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1.  New technique for inter-implant papilla reconstruction between two or more implants in patients with variably reabsorbed ridges and flat anatomy. Preliminary results of a 9 consecutive clinical case series 
Oral & Implantology  2010;3(1):2-11.
The aim of the work.
Interimplant papilla reconstruction is difficult because the biologic width around an implant is apical to the implant-abutment connection and because the biologic width creates subcrestally. The aim of this study is to investigate whether the reconstruction of the interimplant papilla can be achieved by the use of an innovative surgical technique combined with scalloped implants, in the most severe surgical conditions, i.e. in variably reabsorbed ridges with flat anatomy.
Materials and method.
Nine surgical sites, in eight consecutive patients, were treated with at least two adjacent scalloped implants and fixed prosthesis. 23 scalloped implants were placed using this new surgical technique on bone and soft tissue structures. One flat platform implant was also placed between two other scalloped implants. A total of 15 interimplant papillae were examined.
100% of papilla reconstruction at first prosthesis insertion. 13.3% failed to maintain interimplant papillae after 6 months and 20% after 12 months. Also, papilla reconstruction was maintained for 12 months in the mesial and distal embrasure spaces of the flat platform implant.
The combination of the use of adjacent scalloped implants with this surgical approach, even in reabsorbed ridges with flat anatomy, may reform inter-implant bone peaks as support for the papillae.
PMCID: PMC3415335  PMID: 23285375
inter-implant papilla reconstruction/regeneration; scalloped implants; implant design; esthetics; dental papilla
2.  Correcting loss of a papilla following orthodontic space opening (Atherton´s patch) through implant supported rehabilitation. A case report 
The objective of this case report is to describe a surgical and prosthetic technique to create a lost papilla following orthodontic space opening (Atherton´s patch) through implant supported rehabilitation. A switching platform implant was used to replace a left maxillary canine in a unitary interdental edentulous ridge with Atherton´s patch in the distal area of the upper lateral left incisor. The radiographic study revealed correct level of the interproximal bone of the adjacent teeth. A mucoperiosteal flap with crest incision and sulcular extension to the adjacent teeth was made. Special attention was paid to correct position of the implant and the distance (≥ 1.5 mm) between the platform and the roots of the adjacent teeth. A submerged technique was used. Tissue modeling through provisional crown was performed in order to create an ideal emergence profile with total papilla fill recorded at the Atherton´s patch area. Final screw retained CAD-CAM zirconia structure was place. Final follow up was performed 2 years after provisional crown placement, and total fill of both papilla, including at Atherton´s patch area, was recorded.
Key words:Atherton´s patch, papilla, switching platform, implant and orthodontics, esthetic score.
PMCID: PMC3935898  PMID: 24596628
3.  Mucosal dehiscence coverage for dental implant using sprit pouch technique: a two-stage approach 
Soft tissue recessions frequently cause esthetic disharmony and dissatisfaction. Compared with soft tissue coverage around a tooth, the coverage of an implant site is obviously unpredictable. Particularly in the cases of thin mucosa, a significant greater amount of recession takes place compared to thick mucosa. To overcome this problem, this case report demonstrates a two-step mucosal dehiscence coverage technique for an endosseous implant.
A 33-year-old female visited us with the chief complaint of dissatisfaction with the esthetics of an exposed implant in the maxillary left cental incisor region. A partial-thickness pouch was constructed around the dehiscence. A subepithelial connective tissue graft was positioned in the apical site of the implant and covered by a mucosal flap with normal tension. At 12 months after surgery, the recipient site was partially covered by keratinized mucosa. However, the buccal interdental papilla between implant on maxillary left central incisor region and adjacent lateral incisor was concave in shape. To resolve the mucosal recession after the first graft, a second graft was performed with the same technique.
An esthetically satisfactory result was achieved and the marginal soft tissue level was stable 9 months after the second graft.
The second graft was able to resolve the mucosal recession after first graft. This two-step approach has the potential to improve the certainty of esthetic results.
PMCID: PMC3394995  PMID: 22803012
Case report; Dental Esthetics; Mouth mucosa; Oral surgical procedures
4.  Black triangle dilemma and its management in esthetic dentistry 
Dental Research Journal  2013;10(3):296-301.
In recent years, clinician and dentist's esthetic demand in dentistry have increased rapidly, driven by an enhanced awareness of beauty and esthetics. The ultimate goal in modern restorative dentistry is to achieve “white” and “pink” esthetics in esthetically important zones. “White esthetics” is the natural dentition or the restoration of dental hard tissues with suitable materials. “Pink esthetics” refers to the surrounding soft-tissues, which includes the interdental papilla and gingiva that can enhance or diminish the esthetic result. Reconstruction of the lost interdental papilla is one of the most challenging and least predictable problems. Restoration and maintenance of these tissues with adequate surgical and prosthetic techniques are a real challenge in modern esthetic dentistry. Treatment of marginal tissue recession, excessive gingival display, deficient ridges, ridge collapse, and esthetic defects around teeth and implants are some of the esthetic problems associated with the interdental papilla that have to be corrected in todays scenario which has been discussed in this review.
PMCID: PMC3760350  PMID: 24019795
Black triangle disease; interdental papilla; pink esthetics; white esthetics
5.  A simple approach to preserve keratinized mucosa around implants using a pre-fabricated implant-retained stent: a report of two cases 
There is no consensus regarding the relationship between the width of keratinized mucosa and the health of peri-implant tissues, but clinicians prefer to provide enough keratinized mucosa around dental implants for long-term implant maintenance. An apically positioned flap during second stage implant surgery is the chosen method of widening the keratinized zone in simple procedures. However, the routine suture techniques used with this method tend to apply tension over the provisional abutments and decrease pre-existing keratinized mucosa. To overcome this shortcoming, a pre-fabricated implant-retained stent was designed to apply vertical pressure on the labial flap and stabilize it in a bucco-apical direction to create a wide keratinized mucous zone.
During second stage implant surgery, an apically displaced, partial thickness flap with a lingualized incision was retracted. A pre-fabricated stent was clipped over the abutments after connecting to the provisional abutment. Vertical pressure was applied to displace the labial flap. No suture was required and the stent was removed after 10 days.
A clinically relevant amount of keratinized mucosa was achieved around the dental implants. Buccally displaced keratinized mucosa was firmly attached to the underlying periosteum. A slight shrinkage of the keratinized zone was noted after the healing period in one patient, but no discomfort during oral hygiene was reported. Clinically healthy gingiva with enough keratinized mucosa was achieved in both patients.
The proposed technique is a simple and time-effective technique for preserving and providing keratinized tissue around dental implants
PMCID: PMC2931308  PMID: 20827329
Dental esthetics; Dental implants; Gingiva
6.  A staged approach of implant placement in immediate extraction sockets for preservation of peri-implant soft and hard tissue 
Esthetic zone restoration is a challenging aspect in implant dentistry because of two critical factors such as level of bone support and soft tissue dimensions. Preservation of healthy peri-implant tissues is of primary importance for ensuring better esthetics over an extended period. The aim of the present case-series was to evaluate a new staged approach of implant placement in immediate extraction sockets for preservation of peri-implant soft and hard tissues. Four subjects scheduled for extraction of teeth in the esthetic zone with neither a periapical nor periodontal infection and with thick tissue biotype were included. For all the subjects sand blasted, large grit, acid etched platform switched implant with a diameter 2 mm less than the diameter of extraction socket and a conical abutment-implant connection (Morse taper) were placed 2 mm below the crest of the socket, with almost 2 mm gap between the labial plate and the implant with shoulder placed palatally/lingually. The implants were loaded after 2 months healing period and followed for a period of 1-2 years. In all the four patients there was preservation of both hard and soft tissues around the implant with a good esthetic outcome in all the follow up visits. Integrating immediate placement with stable implant-abutment connection, platform switching concept and careful case selection, we can achieve a very good esthetic outcome.
PMCID: PMC4033901  PMID: 24872643
Dental implants; platform switching; tooth extraction
7.  Evaluating the clinical and esthetic outcome of apically positioned flap technique in augmentation of keratinized gingiva around dental implants 
Contemporary Clinical Dentistry  2013;4(3):319-324.
Dental implants though a successful treatment modality there exists controversies regarding the relationship between the adequacy of the keratinized gingiva (KG) and peri-implant health. The presence of an adequate amount of peri-implant KG reduces gingival inflammation and hence soft-tissue augmentation should be frequently considered. Among the various periodontal plastic surgical procedures, the apically displaced flap increases the width of keratinized tissue with reduced patient morbidity. The current study aims at evaluating the esthetic improvement in KG around dental implants applying apically positioned flap (APF) technique.
Materials and Methods:
A total of 10 endosseous dental implants were placed in eight systemically healthy patients. APF surgery was performed at the implant site on the buccal aspect either at the time of implant placement (one stage surgical protocol) or during the implant recovery stage (two stage surgical protocols) for increasing the width of KG and reviewed until 12 weeks post-operatively. The width of KG was evaluated at baseline and at the end of 12 weeks after surgery. Paired t-test was performed to evaluate the changes in the width of KG at baseline and at 12 weeks post-operatively. In addition, soft-tissue esthetic outcome was assessed by using visual analog scale (VAS).
The mean width of KG at baseline was 1.47 mm and 12 weeks post-operatively was 5.42 mm. The gain in KG from baseline was 3.95 mm with the P value of 0.000, which was highly statistically significant. The assessment of esthetic outcome using VAS gave an average score of 7.1 indicating good esthetics.
The technique of APF yielded a significant improvement in keratinized tissue, which is both functionally and esthetically acceptable.
PMCID: PMC3793552  PMID: 24124297
Dental esthetics; dental implants; flap; gingiva
8.  The use of definitive implant abutments for the fabrication of provisional crowns: a case series 
The anterior region is a challenge for most clinicians to achieve optimal esthetics with dental implants. The provisional crown is a key factor in the success of obtaining pink esthetics around restorations with single implants, by soft tissue and inter-proximal papilla shaping. Provisional abutments bring additional costs and make the treatment more expensive. Since one of the aims of the clinician is to reduce costs and find more economic ways to raise patient satisfaction, this paper describes a practical method for chair-side fabrication of non-occlusal loaded provisional crowns used by the authors for several years successfully.
Twenty two patients (9 males, 13 females; mean age, 36,72 years) with one missing anterior tooth were treated by using the presented method. Metal definitive abutments instead of provisional abutments were used and provisional crowns were fabricated on the definitive abutments for all of the patients. The marginal fit was finished on a laboratory analogue and temporarily cemented to the abutments. The marginal adaptation of the crowns was evaluated radiographically.
The patients were all satisfied with the final appearance and no complications occurred until the implants were loaded with permanent restorations.
The use of the definitive abutments for provisional crowns instead of provisional abutments reduces the costs and the same results can be obtained.
PMCID: PMC3213236  PMID: 22087416
Dental abutments; Dental implants; Dental marginal adaptation; Dental prosthesis
9.  Soft tissue grafting to improve implant esthetics 
Dental implants are becoming the treatment of choice to replace missing teeth, especially if the adjacent teeth are free of restorations. When minimal bone width is present, implant placement becomes a challenge and often resulting in recession and dehiscence around the implant that leads to subsequent gingival recession. To correct such defect, the author turned to soft tissue autografting and allografting to correct a buccal dehiscence around tooth #24 after a malpositioned implant placed by a different surgeon. A 25-year-old woman presented with the chief complaint of gingival recession and exposure of implant threads around tooth #24. The patient received three soft tissue grafting procedures to augment the gingival tissue. The first surgery included a connective tissue graft to increase the width of the keratinized gingival tissue. The second surgery included the use of autografting (connective tissue graft) to coronally position the soft tissue and achieve implant coverage. The third and final surgery included the use of allografting material Alloderm to increase and mask the implant from showing through the gingiva. Healing period was uneventful for the patient. After three surgical procedures, it appears that soft tissue grafting has increased the width and height of the gingiva surrounding the implant. The accomplished thickness of gingival tissue appeared to mask the showing of implant threads through the gingival tissue and allowed for achieving the desired esthetic that the patient desired. The aim of the study is to present a clinical case with soft tissue grafting procedures.
PMCID: PMC3645463  PMID: 23662087
case report; connective tissue; dental implants; allograft; coronally positioned flap
10.  Peri-implant soft tissue management: Where are we? 
Dental implants have evolved dramatically over the last decade, and so have our expectations from them in terms of functional and esthetic criteria. The maintenance and augmentation of the soft tissue has emerged as an area of concern and focus. The triad of anatomical peri-implant characteristics, soft tissue response to the implant material, and clinical skill form the fundamental principles in augmenting soft tissue. However, as clinicians, where are we with regards to the ability to augment and maintain soft tissue around dental implants, about 40 years after the first implants were placed? We now understand that peri-implant soft tissue management begins with extraction management. Our treatment modalities have evolved from socket compression post-extraction, to socket preservation with an aim to enhance the eventual peri-implant soft tissue. This short communication will assess the evolution of our thought regarding peri-implant soft tissue management, augmentation of keratinized mucosa around implants, and also look at some recent techniques including the rotated pedicle connective tissue graft for enhancing inter-implant papilla architecture. With newer research modalities, such as cyto-detachment technology, and cutting-edge bioengineering solutions (possibly a soft-tissue-implant construct) which might be available in the near future for enhancing soft tissue, we are certainly in an exciting era in dentistry.
PMCID: PMC3590740  PMID: 23493178
Dental implant; dental implantology; graft; grafting; tissue
11.  An analysis on the factors responsible for relative position of interproximal papilla in healthy subjects 
This study examined the factors that can be associated with the appearance of the interproximal papilla.
One hundred and forty-seven healthy interproximal papillae between the maxillary central incisors were examined. For each subject, a digital photograph and periapical radiograph of the interdental embrasure were taken using a 1-mm grid metal piece. The following parameters were recorded: the amount of recession of the interproximal papilla, contact point-bone crest distance, contact point-cemento-enamel junction (CEJ) distance, CEJ-bone crest distance, inter-radicular distance, tooth shape, embrasure space size, interproximal contact area, gingival biotype, papilla height, and papilla tip form.
The amount of recession of the interproximal papilla was associated with the following: 1) increase in contact point-bone crest, contact point-CEJ, and CEJ-bone crest distance; 2) increase in the inter-radicular distance; 3) triangular tooth shape; 4) decrease in the interproximal contact area length; 5) increase in the embrasure space size; and 6) flat papilla tip form. On the other hand, the amount of gingival recession was not associated with the gingival biotype or papilla height. In the triangular tooth shape, the contact point-bone crest distance and inter-radicular distance were longer, the interproximal contact area length was shorter, and the embrasure space size was larger. The papilla tip form became flatter with increasing inter-radicular distance and CEJ-bone crest distance.
The relative position of the interproximal papilla in healthy subjects was associated with the multiple factors and each factor was related to the others. A triangular tooth shape carries a higher risk of recession of the interproximal papilla because the proximal contact point is positioned more incisally and the bone crest is positioned more apically. This results in an increase in recession of the interproximal papilla and flat papilla tip form.
PMCID: PMC3769594  PMID: 24040568
Gingiva; Gingival recession
12.  Multiple Marginal Tissue Recession Treated with a Simplified Lateral Sliding Flap Technique 
Case Reports in Dentistry  2014;2014:432960.
Marginal tissue recession is a common esthetic problem that is usually accompanied by dentin sensitivity, and patients frequently report a fear of dental loss. Lateral sliding flaps have been used for localized recession, but they are rarely used for multiple recessions. The aim of this paper was to report a case of coverage of multiple marginal tissue recessions by means of a lateral sliding flap associated with a connective tissue graft. This was a modification of Nelson's technique, which was originally described as the combination of the double papilla technique, lateral sliding flap, and connective tissue graft. In the present case, double papilla was not performed, rendering the maneuver less complicated. After surgery on teeth #23 to #25, total root coverage, decreased dentin sensitivity, and increased keratinized tissue band and gingival thickness were achieved. In the present case, modified Nelson technique proved to be a more simple procedure for the treatment of multiple recessions in one session, resulting in adequate healing, predictable root coverage, and, more importantly, esthetic and functional success.
PMCID: PMC4221904  PMID: 25400955
13.  Novel Techniques with the Aid of a Staged CBCT Guided Surgical Protocol 
Case Reports in Dentistry  2015;2015:439706.
The case report will present some novel techniques for using a “staged” protocol utilizing strategic periodontally involved teeth as transitional abutments in combination with CBCT guided implant surgery. Staging the case prevented premature loading of the grafted sites during the healing phase. A CBCT following a tenting screw guided bone regeneration procedure ensured adequate bone to place an implant fixture. Proper assessment of the CBCT allowed the surgeon to do an osteotome internal sinus lift in an optimum location. The depth of the bone needed for the osteotome sinus floor elevation was planned. The staged appliance allowed these sinus-augmented sites to heal for an extended period of time compared to implants, which were uncovered and loaded at an earlier time frame. The staged protocol and CBCT analysis enabled the immediate implants to be placed in proper alignment to the adjacent fixture. After teeth were extracted, the osseointegrated implants were converted to abutments for the transitional appliance. Finally, the staged protocol allowed for soft tissue enhancement in the implant and pontic areas prior to final insertion of the prosthesis.
PMCID: PMC4302971  PMID: 25632356
14.  A Focus on Soft Tissue in Dental Implantology 
Most of the focus in the early dental implant literature is on the bone to titanium interface because a successful Osseo integrated implant requires direct bone contact to the implant surface. The importance of soft tissue in the ability of dental implants to restore function and esthetics has often been underestimated. This paper reviews the pertinent literature on soft tissue healing and management in partially edentulous dental implant patients. Patients seek treatment to replace missing teeth and to improve comfort, function and/or esthetics. Healing around dental implants is affected by the patient’s health, soft and hard tissue contours, and the use and care of the prosthesis, surgical augmentation and placement, and the design of the definitive prosthesis. Several surgical and non-surgical procedures have been proposed to treat the soft tissue deformities in the interproximal areas. This review also discusses the interdental papilla and various approaches to preserve and restore the same. Most of the research was based on scientifically legitimate sources of information obtained from primary literature, other appropriate technical references and searching using various online resources.
PMCID: PMC3416938  PMID: 23997462
Implants; Soft tissue; Surgical management; Non-surgical management
15.  Marginal bony changes in relation to different vertical positions of dental implants 
The purpose of this study was to radiographically evaluate marginal bony changes in relation to different vertical positions of dental implants.
Two hundred implants placed in 107 patients were examined. The implants were classified by the vertical positions of the fixture-abutment connection (microgap): 'bone level,' 'above bone level,' or 'below bone level.' Marginal bone levels were examined in the radiographs taken immediately after fixture insertion, immediately after second-stage surgery, 6 months after prosthesis insertion, and 1 year after prosthesis insertion. Radiographic evaluation was carried out by measuring the distance between the microgap and the most coronal bone-to-implant contact (BIC).
Immediately after fixture insertion, the distance between the microgap and most coronal BIC was 0.06 ± 0.68 mm; at second surgery, 0.43 ± 0.83 mm; 6 months after loading, 1.36 ± 0.56 mm; and 1 year after loading, 1.53 ± 0.51 mm (mean ± SD). All bony changes were statistically significant but the difference between the second surgery and the 6-month loading was greater than between other periods. In the 'below bone level' group, the marginal bony change between fixture insertion and 1 year after loading was about 2.25 mm, and in the 'bone level' group, 1.47 mm, and in 'above bone level' group, 0.89 mm. Therefore, the marginal bony change was smaller than other groups in the 'above bone level' group and larger than other groups in the 'below bone level' group.
Our results demonstrated that marginal bony changes occur during the early phase of healing after implant placement. These changes are dependent on the vertical positions of implants.
PMCID: PMC2967813  PMID: 21072222
Alveolar bone loss; Dental implants
16.  Clinical Evaluation of Papilla Reconstruction Using Subepithelial Connective Tissue Graft 
Objective: The aesthetics of the patient can be improved by surgical reconstruction of interdental papilla by using an advanced papillary flap interposed with subepithelial connective tissue graft.
Materials and Methods: A total of fifteen sites from ten patients having black triangles/papilla recession in the maxillary anterior region were selected and subjected to presurgical evaluation. The sites were treated with interposed subepithelial connective tissue graft placed under a coronally advance flap. The integrity of the papilla was maintained by moving the whole of gingivopapillary unit coronally. The various parameters were analysed at different intervals.
Results: There was a mean decrease in the papilla presence index score and distance from contact point to gingival margin, but it was statistically not significant. Also, there is increase in the width of the keratinized gingiva which was statistically highly significant.
Conclusion: Advanced papillary flap with interposed sub–epithelial connective tissue graft can offer predictable results for the reconstruction of interdental papilla. If papilla loss occurs solely due to soft-tissue damage, reconstructive techniques can completely restore it; but if due to periodontal disease involving bone loss, reconstruction is generally incomplete and multiple surgical procedures may be required.
PMCID: PMC4225981  PMID: 25386529
Aesthetic; Black triangle; Interdental papilla; Subepithelial connective tissue graft
17.  An evaluation of a periodontal plastic surgical procedure for the reconstruction of interdental papillae in maxillary anterior region: A clinical study 
In today's world, people are very much aware about their looks and personality. They are getting more concerned about the esthetics and thus are not ready to compromise the appearance of black holes, especially in the anterior region of the mouth. Various techniques like orthodontic correction, prosthetic veneers and various periodontal surgical methods have been used to cover these unaesthetic open embrasures. In the present study, a variant technique given by Beagle in 1992 was used to cover these open gingival embrasures. The technique uses a gingival flap from the labial aspect to close the open gingival embrasures thus solving the problem of black holes.
Aims and Objectives:
This clinical study was aimed to reconstruct the lost or blunted interdental papillae with gingival tissue for esthetic purpose and for maintaining oral health with the objective to determine the extent to which the procedure can revert the maxillary esthetics.
Materials and Methods:
The patients selected were those who were having a complaint of at least one black hole in the maxillary anterior region with grade ‘0’ or ‘1’ type of contour of interdental tissues. A total of 39 open embrasures were surgically closed using this technique. Various indices were taken pre-surgically and then again post surgically.
Plaque index and gingival index showed an initial increase in the scores at the end of 1 week. Later, there was a gradual fall till the end of the study. Bleeding index significantly increased at the end of 12 weeks (P<0.001) but reduced to insignificant levels at the end of 24 weeks (P<0.09). The sulcus depth increased by about 1.19 mm. There was improvement in the contour of interdental tissues in 51% of cases and in 38.46% the interdental papillae completely obliterated the open embrasures.
The surgical technique used here for reconstruction of interdental papilla was fairly successful. However, use of bone grafts or soft tissue grafts would have improved the results further.
PMCID: PMC3590722  PMID: 23493264
Black holes; gingival flap; open embrasures; periodontal plastic surgery; unaesthetic appearance
18.  Intrastromal Corneal Ring Implants for Corneal Thinning Disorders 
Executive Summary
The purpose of this project was to determine the role of corneal implants in the management of corneal thinning disease conditions. An evidence-based review was conducted to determine the safety, effectiveness and durability of corneal implants for the management of corneal thinning disorders. The evolving directions of research in this area were also reviewed.
Subject of the Evidence-Based Analysis
The primary treatment objectives for corneal implants are to normalize corneal surface topography, improve contact lens tolerability, and restore visual acuity in order to delay or defer the need for corneal transplant. Implant placement is a minimally invasive procedure that is purported to be safe and effective. The procedure is also claimed to be adjustable, reversible, and both eyes can be treated at the same time. Further, implants do not limit the performance of subsequent surgical approaches or interfere with corneal transplant. The evidence for these claims is the focus of this review.
The specific research questions for the evidence review were as follows:
Corneal Surface Topographic Effects:
Effects on corneal surface remodelling
Impact of these changes on subsequent interventions, particularly corneal transplantation (penetrating keratoplasty [PKP])
Visual Acuity
Refractive Outcomes
Visual Quality (Symptoms): such as contrast vision or decreased visual symptoms (halos, fluctuating vision)
Contact lens tolerance
Functional visual rehabilitation and quality of life
Patient satisfaction:
Disease Process:
Impact on corneal thinning process
Effect on delaying or deferring the need for corneal transplantation
Clinical Need: Target Population and Condition
Corneal ectasia (thinning) comprises a range of disorders involving either primary disease conditions such as keratoconus and pellucid marginal corneal degeneration or secondary iatrogenic conditions such as corneal thinning occurring after LASIK refractive surgery. The condition occurs when the normally round dome-shaped cornea progressively thins causing a cone-like bulge or forward protrusion in response to the normal pressure of the eye. Thinning occurs primarily in the stoma layers and is believed to be a breakdown in the collagen network. This bulging can lead to an irregular shape or astigmatism of the cornea and, because the anterior part of the cornea is largely responsible for the focusing of light on the retina, results in loss of visual acuity. This can make even simple daily tasks, such as driving, watching television or reading, difficult to perform.
Keratoconus (KC) is the most common form of corneal thinning disorder and is a noninflammatory chronic disease process. Although the specific causes of the biomechanical alterations that occur in KC are unknown, there is a growing body of evidence to suggest that genetic factors may play an important role. KC is a rare condition (<0.05% of the population) and is unique among chronic eye diseases as it has an early age of onset (median age of 25 years). Disease management for this condition follows a step-wise approach depending on disease severity. Contact lenses are the primary treatment of choice when there is irregular astigmatism associated with the disease. When patients can no longer tolerate contact lenses or when lenses no longer provide adequate vision, patients are referred for corneal transplant.
Keratoconus is one of the leading indications for corneal transplants and has been so for the last three decades. Yet, despite high graft survival rates of up to 20 years, there are reasons to defer receiving transplants for as long as possible. Patients with keratoconus are generally young and life-long term graft survival would be an important consideration. The surgery itself involves lengthy time off work and there are potential complications from long term steroid use following surgery, as well as the risk of developing secondary cataracts, glaucoma etc. After transplant, recurrent KC is possible with need for subsequent intervention. Residual refractive errors and astigmatism can remain challenging after transplantation and high refractive surgery rates and re-graft rates in KC patients have been reported. Visual rehabilitation or recovery of visual acuity after transplant may be slow and/or unsatisfactory to patients.
Description of Technology/Therapy
INTACS® (Addition Technology Inc. Sunnyvale, CA, formerly KeraVision, Inc.) are the only currently licensed corneal implants in Canada. The implants are micro-thin poly methyl methacrylate crescent shaped ring segments with a circumference arc length of 150 degrees, an external diameter of 8.10 mm, an inner diameter of 6.77 mm, and a range of different thicknesses. Implants act as passive spacers and, when placed in the cornea, cause local separation of the corneal lamellae resulting in a shortening of the arc length of the anterior corneal curvature and flattening the central cornea. Increasing segment thickness results in greater lamellar separation with increased flattening of the cornea correcting for myopia by decreasing the optical power of the eye. Corneal implants also improve corneal astigmatism but the mechanism of action for this is less well understood.
Treatment with corneal implants is considered for patients who are contact lens intolerant, having adequate corneal thickness particularly around the area of the implant incision site and without central corneal scarring. Those with central corneal scarring would not benefit from implants and those without an adequate corneal thickness, particularly in the region that the implants are being inserted, would be at increased risk for corneal perforation. Patients desiring to have visual rehabilitation that does not include glasses or contact lenses would not be candidates for corneal ring implants.
Placement of the implants is an outpatient procedure with topical anesthesia generally performed by either corneal specialists or refractive surgeons. It involves creating tunnels in the corneal stroma to secure the implants either by a diamond knife or laser calibrated to an approximate depth of 70% of the cornea. Variable approaches have been employed by surgeons in selecting ring segment size, number and position. Generally, two segments of equal thickness are placed superiorly and inferiorly to manage symmetrical patterns of corneal thinning whereas one segment may be placed to manage asymmetric thinning patterns.
Following implantation, the major safety concerns are for potential adverse events including corneal perforation, infection, corneal infiltrates, corneal neovascularization, ring migration and extrusion and corneal thinning. Technical results can be unsatisfactory for several reasons. Treatment may result in an over or under-correction of refraction and may induce astigmatism or asymmetry of the cornea.
Progression of the corneal cone with corneal opacities is also invariably an indication for progression to corneal transplant. Other reasons for treatment failure or patient dissatisfaction include foreign body sensation, unsatisfactory visual quality with symptoms such as double vision, fluctuating vision, poor night vision or visual side effects related to ring edge or induced or unresolved astigmatism.
Evidence-Based Analysis Methods
The literature search strategy employed keywords and subject headings to capture the concepts of 1) intrastromal corneal rings and 2) corneal diseases, with a focus on keratoconus, astigmatism, and corneal ectasia. The initial search was run on April 17, 2008, and a final search was run on March 6, 2009 in the following databases: Ovid MEDLINE (1996 to February Week 4 2009), OVID MEDLINE In-Process and Other Non-Indexed Citations, EMBASE (1980 to 2009 Week 10), OVID Cochrane Library, and the Centre for Reviews and Dissemination/International Agency for Health Technology Assessment. Parallel search strategies were developed for the remaining databases. Search results were limited to human and English-language published between January 2000 and April 17, 2008. The resulting citations were downloaded into Reference Manager, v.11 (ISI Researchsoft, Thomson Scientific, U.S.A), and duplicates were removed. The Web sites of several other health technology agencies were also reviewed including the Canadian Agency for Drugs and Technologies in Health (CADTH), ECRI, and the United Kingdom National Institute for Clinical Excellence (NICE). The bibliographies of relevant articles were scanned.
Inclusion Criteria
English language reports and human studies
Any corneal thinning disorder
Reports with corneal implants used alone or in conjunction with other interventions
Original reports with defined study methodology
Reports including standardized measurements on outcome events such as technical success, safety, effectiveness, durability, vision quality of life or patient satisfaction
Case reports or case series for complications and adverse events
Exclusion Criteria
Non-systematic reviews, letters, comments and editorials
Reports not involving outcome events such as safety, effectiveness, durability, vision quality or patient satisfaction following an intervention with corneal implants
Reports not involving corneal thinning disorders and an intervention with corneal implants
Summary of Findings
In the MAS evidence review on intrastromal corneal ring implants, 66 reports were identified on the use of implants for management of corneal thinning disorders. Reports varied according to their primary clinical indication, type of corneal implant, and whether or not secondary procedures were used in conjunction with the implants. Implants were reported to manage post LASIK thinning and/or uncorrected refractive error and were also reported as an adjunctive intervention both during and after corneal transplant to manage recurrent thinning and/or uncorrected refractive error.
Ten pre-post cohort longitudinal follow-up studies were identified examining the safety and effectiveness of INTAC corneal implants in patients with keratoconus. Five additional cohort studies were identified using the Ferrara implant for keratoconus management but because this corneal implant is not licensed in Canada these studies were not reviewed.
The cohorts implanted with INTACS involved 608 keratoconus patients (754 eyes) followed for 1, 2 or 3 years. Three of the reports involved ≥ 2 years of follow-up with the longest having 5-year follow-up data for a small number of patients. Four of the INTAC cohort studies involved 50 or more patients; the largest involved 255 patients. Inclusion criteria for the studies were consistent and included patients who were contact lens intolerant, had adequate corneal thickness, particularly around the area of the implant incision site, and without central corneal scarring. Disease severity, thinning pattern, and corneal cone protrusions all varied and generally required different treatment approaches involving defined segment sizes and locations.
A wide range of outcome measures were reported in the cohort studies. High levels of technical success or ability to place INTAC segments were reported. Technically related complications were often delayed and generally reported as segment migration attributable to early experience. Overall, complications were infrequently reported and largely involved minor reversible events without clinical sequelae.
The outcomes reported across studies involved statistically significant and clinically relevant improvements in corneal topography, refraction and visual acuity, for both uncorrected and best-corrected visual acuity. Patients’ vision was usually restored to within normal functioning levels and for those not achieving satisfactory correction, insertion of intraocular lenses was reported in case studies to result in additional gains in visual acuity. Vision loss (infrequently reported) was usually reversed by implant exchange or removal. The primary effects of INTACS on corneal surface remodelling were consistent with secondary improvements in refractive error and visual acuity. The improvements in visual acuity and refractive error noted at 6 months were maintained at 1 and 2-year follow-up
Improvements in visual acuity and refractive error following insertion of INTACS, however, were not noted for all patients. Although improvements were not found to vary across age groups there were differences across stages of disease. Several reports suggested that improvements in visual acuity and refractive outcomes may not be as large or predictable in more advanced stages of KC. Some studies have suggested that the effects of INTACs were much greater in flattening the corneal surface than in correcting astigmatism. However, these studies involved small numbers of high risk patients in advanced stages of KC and conclusions made from this group are limited.
INTACS were used for other indications other than primary KC. The results of implant insertion on corneal topography, refraction, and visual acuity in post-LASIK thinning cases were similar to those reported for KC. The evidence for this indication, however, only involved case reports and small case series. INTACS were also successfully used to treat recurrent KC after corneal transplant but this was based on only a single case report. Corneal implants were compared to corneal transplantation but these studies were not randomized and based on small numbers of selected patients.
The foremost limitation of the evidence base is the basic study design in the reports that involved longitudinal follow-up only for the treated group; there were no randomized trials. Follow-up in the trials (although at prescribed intervals) often had incomplete accounts of losses at follow-up and estimates of change were often not reported or based on group differences. Second, although standardized outcome measures were reported, contact lens tolerance (a key treatment objective) was infrequently specified. A third general limitation was the lack of reporting of patients’ satisfaction with their vision quality or functional vision. Outcome measures for vision quality and impact on patient quality of life were available but rarely reported and have been noted to be a limitation in ophthalmological literature in general. Fourth, the longitudinal cohort studies have not followed patients long enough to evaluate the impact of implants on the underlying disease process (follow-up beyond 3 years is limited). Additionally, only a few of these studies directly examined corneal thinning in follow-up. The overall quality of evidence determined using the GRADE hierarchy of evidence was moderate.
There is some evidence in these studies to support the claim that corneal implants do not interfere with, or increase the difficultly of, subsequent corneal transplant, at least for those performed shortly after INTAC placement. Although it’s uncertain for how long implants can delay the need for a corneal transplant, given that patients with KC are often young (in their twenties and thirties), delaying transplant for any number of years may still be a valuable consideration.
The clinical indications for corneal implants have evolved from management of myopia in normal eyes to the management of corneal thinning disorders such as KC and thinning occurring after refractive surgery. Despite the limited evidence base for corneal implants, which consists solely of longitudinal follow-up studies, they appear to be a valuable clinical tool for improving vision in patients with corneal thinning. For patients unable to achieve functional vision, corneal implants achieved statistically significant and clinically relevant improvements in corneal topography, refraction, and visual acuity, providing a useful alternative to corneal transplant. Implants may also have a rescue function, treating corneal thinning occurring after refractive surgery in normal eyes, or managing refractive errors following corneal transplant. The treatment offers several advantages in that it’s an outpatient based procedure, is associated with minimal risk, and has high technical success rates. Both eyes can be treated at once and the treatment is adjustable and reversible. The implants can be removed or exchanged to improve vision without limiting subsequent interventions, particularly corneal transplant.
Better reporting on vision quality, functional vision and patient satisfaction, however, would improve evaluation of the impact of these devices. Information on the durability of the implants’ treatment effects and their affects on underlying disease processes is limited. This information is becoming more important as alternative treatment strategies, such as collagen cross-linking aimed at strengthening the underlying corneal tissue, are emerging and which might prove to be more effective or increase the effectiveness of the implants, particularly in advances stages of corneal thinning.
Ontario Health System Considerations
At present there are approximately 70 ophthalmologists in Canada who’ve had training with corneal implants; 30 of these practice in Ontario. Industry currently sponsors the training, proctoring and support for the procedure. The cost of the implant device ranges from $950 to $1200 (CAD) and costs for instrumentation range from $20,000 to $30,000 (CAD) (a one time capital expenditure). There is no physician services fee code for corneal implants in Ontario but assuming that they are no higher than those for a corneal transplant, the estimated surgical costs would be $914.32(CAD) An estimated average cost per patient, based on device costs and surgical fees, for treatment is $1,964 (CAD) (range $1,814 to $2,114) per eye. There have also been no out of province treatment requests. In Ontario the treatment is currently being offered in private clinics and an increasing number of ophthalmologists are being certified in the technique by the manufacturer.
KC is a rare disease and not all of these patients would be eligible candidates for treatment with corneal implants. Based on published population rates of KC occurrence, it can be expected that there is a prevalent population of approximately 6,545 patients and an incident population of 240 newly diagnosed cases per year. Given this small number of potential cases, the use of corneal implants would not be expected to have much impact on the Ontario healthcare system. The potential impact on the provincial budget for managing the incident population, assuming the most conservative scenario (i.e., all are eligible and all receive bilateral implants) ranges from $923 thousand to $1.1 million (CAD). This estimate would vary based on a variety of criteria including eligibility, unilateral or bilateral interventions, re-interventions, capacity and uptake
Keratoconus, corneal implants, corneal topography, corneal transplant, visual acuity, refractive error
PMCID: PMC3385416  PMID: 23074513
19.  Interproximal Papillae Reconstruction around Implant Using Subepithelial Connective Tissue Graft in Maxillary Anterior Region: A Case Series 
The present study was undertaken to evaluate the effectiveness of interproximal papillae reconstruction around early loaded single implant using subepithelial connective tissue graft in maxillary anterior region.
Material and Methods
Ten systemically healthy patients (mean age = 29.3 [SD 7.9] years) in need of dental implants in maxillary anterior region were included in the study. Interproximal papillae reconstruction around single implant using subepithelial connective tissue graft was applied. The donor palatal tissue was harvested by a "trap door approach". Subepithelial connective tissue graft was inserted in the pouch created on mesial and distal site of implant. Clinical and radiographic parameters were recorded around the each implant, including papillary height and papillary gingival contour, at baseline, 3 and 6 months after operation.
The mesial papilla height was increased by 1.9 (SD 0.87) mm, P = 0.005 at 3 month and maintained at 1.5 (SD 0.97) mm, P = 0.007 at 6 months. The distal papilla height was increased by 2 (SD 0.66) mm, P = 0.004 at 3 month and maintained at 1.2 (SD 0.78) mm, P = 0.010 at 6 months. Assessment of papilla contour index showed 90% aesthetic success both for mesial and distal papilla at 6 months.
It can be concluded that subepithelial connective tissue graft may be used to successfully augment the gingival papillae adjacent to single tooth implant restoration.
PMCID: PMC3886102  PMID: 24422008
dental papilla; single-tooth dental implant; early dental implant loading; tissue grafts; tissue transplants.
20.  Soft tissue expansion before vertical ridge augmentation: Inflatable silicone balloons or self-filling osmotic tissue expanders? 
Recent advances in periodontal plastic surgical procedures allow the clinician to reconstruct deficient alveolar ridges in more predictable ways than previously possible. Placement of implant/s in resorbed ridges poses numerous challenges to the clinician for successful esthetic and functional rehabilitation. The reconstruction frequently utilizes one or combination of periodontal plastic surgical procedures in conjunction with autogenous bone grafting, allogenic bone block grafting, ridge split techniques, distraction osteogenesis, or guided bone regeneration (GBR) for most predictable outcomes. Current surgical modalities used in reconstruction of alveolar ridge (horizontal and/or vertical component) often involve the need of flap transfer. Moreover, there is compromise in tissue integrity and color match owing to different surgical site and the tissue utilized is insufficient in quantity leading to post surgical graft exposition and/or loss of grafted bone. Soft tissue expansion (STE) by implantation of inflatable silicone balloon or self filling osmotic tissue expanders before reconstructive surgery can overcome these disadvantages and certainly holds a promise for effective method for generation of soft tissue thereby achieving predictable augmentation of deficient alveolar ridges for the implant success. This article focuses and compares these distinct tissue expanders for their clinical efficacy of achieving excess tissue that predominantly seems to be prerequisite for ridge augmentation which can be reasonably followed by successful placement of endosseous fixtures.
PMCID: PMC4158582  PMID: 25210255
Alveolar ridge reconstruction; bone grafts; controlled tissue expansion; dental implants; soft tissue expansion; systematic review
21.  Papillae alterations around single-implant restorations in the anterior maxillae: thick versus thin mucosa 
To evaluate the papilla alterations around single-implant restorations in the anterior maxillae after crown attachment and to study the influence of soft tissue thickness on the papilla fill alteration. According to the inclusion criteria, 32 patients subjected to implant-supported single-tooth restorations in anterior maxillae were included. The patients were assigned to two groups according to the mucosal thickness: (i) group 1, 1.5 mm≤mucosal thickness≤3 mm; and (ii) group 2, 3 mm
PMCID: PMC3412666  PMID: 22627613
esthetic outcome; papilla fill index; single-implant restoration; soft tissue thickness
Seminars in Plastic Surgery  2011;25(4):265-272.
Extensive defects of the ear require satisfactory cosmetic reconstruction to enable the patient to achieve full social integration. Although surgical procedures are the gold standard for reconstruction of the ear, in some cases they cannot be performed because of extended scars, threatening tumor, or congenital tissue abnormalities. Prosthetic reconstruction of the auricle is an established and reliable alternative technique to autologous surgical reconstructions. Since studies performed by Brånemark, osseointegrated implants have been widely used to provide a reliable and stable anchorage for a prosthesis (prosthesis anchored to bone). To allow good osseointegration of the titanium screw implants, two stages are necessary. After careful preparation for the surgical procedure (local and general examination, computed tomography scan, skin preparation), screws are implanted into bone, which are then covered by a skin flap. During the second stage, the skin is incised, and penetrating fixtures are attached to the screw implants, which allow fixation of the prosthesis. This procedure is reliable and reproducible, with good to excellent results and stability over time.
PMCID: PMC3312151  PMID: 23115532
Prosthesis; ear; osseointegration; plastic surgery
The Open Dentistry Journal  2010;4:165-171.
Oral rehabilitation for a patient with severe loss of alveolar bone and soft tissue resulting from severe periodontitis presents a challenge to clinicians. Replacing loosening natural teeth with fixed prostheses supported by dental implants often requires either gingival surgery or bone grafting. The outcome of the bone grafting is sometimes unpredictable and requires longer healing time and/ or multiple surgeries. The presence of periodontal inflammation and periapical lesions often delay the placement of bone grafts as well as dental implants. Here we present a clinical case of a patient undergone full mouth reconstruction with implant-supported fixed prostheses. We demonstrated that early placement of implants (three weeks after extractions) with minimal bone grafting may be an alternative to conventional bone grafting followed by implant placement. We believe that primary stability during implant placement may contribute to our success. In addition, composite resin gingival material may be indicated in cases of large fixed implant prostheses as an alternative to pink porcelain.
PMCID: PMC3041016  PMID: 21339901
Dental implants; Full mouth rehabiliation; Full mouth reconstruction; Periodontitis; Early implant placement.
The Saudi Dental Journal  2011;23(3):129-133.
Around dental implants exists a “biologic width” of few millimeters that have to be preserved in order to not have adverse effect on soft and hard tissues around implant. Because the minimum distance between adjacent implants has not been determined yet, we therefore, decided to perform a retrospective study on a series of spiral family implants (SFIs) to verify the minimum inter-implants’ distance that has an impact on crestal bone resorption.
Materials and Methods
Fifty-nine implants were investigated with a mean follow-up of 14 months. Implant diameter was 3.75, 4.2, 5 and 6 mm in 11 (18.6%), 29 (49.2%), 17 (28.8%) and 2 (3.4%) SFIs. Implant length was shorter than 13 mm, equal to 13 mm and 16 mm in 23 (39%), 23 (39%) and 13 (22%) SFIs. Implants were inserted to replace 13 incisors (22%), 7 cuspids (11.9%), 30 premolars (50.8%) and 9 molars (15.3%). Twenty-seven fixtures were inserted in post-extractive sockets and the remaining 32 in healed bone; 36 (61%) were immediately loaded. In addition to the above mentioned implant-related factors, several host- and surgery-factors were investigated. Independent samples T-test, univariate and multivariate analysis were used to detect those variables associated with the clinical outcome.
Data were evaluated with a two steps statistical analysis (i.e. univariate and multivariate) after having grouped implants in two series: those with an implant-implant distance less of 1.8 mm and those with an implant-implants distance greater than 1.8 mm. In univariate analysis, post-extractive implants and number of prosthetic units were statistically significant. In multivariate analysis, only post-extractive implants have a significant adverse effect on crestal bone resorption.
Adjacent implants inserted with a distance lower and higher than 1.8 mm have difference in crestal bone resorption but this difference is not statistically significant in a short period follow up. This could due to the specific implant used that has a reverse conical neck. No statistical difference was detected between implant subtypes. Post-extractive implant insertion is the major determinant in terms of peri-implant bone resorption in a short period follow-up.
PMCID: PMC3723294  PMID: 23960506
Implant; Tooth; Width; Resorption; Biology
Journal of Pharmacy & Bioallied Sciences  2014;6(Suppl 1):S34-S38.
Anchorage control is a critical consideration when planning treatment for patients with dental and skeletal malocclusions. To obtain sufficient stability of implants, the thickness of the soft tissue and the cortical-bone in the placement site must be considered; so as to provide an anatomical map in order to assist the clinician in the placement of the implants.
The aim of this study is to evaluate the thickness of soft- and hard-tissue.
Materials and Methods:
To measure soft tissue and cortical-bone thicknesses, 12 maxillary cross-sectional specimens were obtained from the cadavers, which were made at three maxillary mid-palatal suture areas: The interdental area between the first and second premolars (Group 1), the second premolar and the first molar (Group 2), and the first and second molars (Group 3). Sectioned samples along with reference rulers were digitally scanned. Scanned images were calibrated and measurements were made with image-analysis software. We measured the thickness of soft and hard-tissues at five sectional areas parallel to the buccopalatal cementoenamel junction (CEJ) line at 2-mm intervals and also thickness of soft tissue at the six landmarks including the incisive papilla (IP) on the palate. The line perpendicular to the occlusal plane was made and measurement was taken at 4-mm intervals from the closest five points to IP.
(1) Group 1:6 mm from CEJ in buccal side and 2 mm from CEJ in palatal side. (2) Group 2:8 mm from CEJ in buccal side and 4 mm from CEJ in palatal side. (3) Group 3:8 mm from CEJ in buccal side and 8 mm from CEJ in palatal side.
The best site for placement of implant is with thinnest soft tissue and thickest hard tissue, which is in the middle from CEJ in buccal side and closest from CEJ in palatal side in Group 1 and faraway from CEJ in buccal side and closest from CEJ in palatal side in Group 2 and faraway from CEJ in buccal side and faraway from CEJ in palatal side in Group 3.
PMCID: PMC4157277  PMID: 25210381
Anchorage; hard tissue; implant stability; soft tissue

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