This study was conducted in the Department of Pedodontics and Preventive Dentistry, College of Dental Surgery, Manipal, in collaboration with Department of Ayurveda and Department of Microbiology, Kasturba Medical College, MAHE after obtaining Ethics Committee Permission. A total of 1501 students in the age group of 8–12 years, belonging to classes 4th to 6th were the subjects for this study and a total of eight schools around Manipal were included in this study.
Materials used for recording indices were mouth mirror, explorer, tweezers and chip syringe; for oral prophylaxis - hand scalers, disclosing solution, polishing paste, cup and brush, portable micromotor with handpiece.
Before the commencement of the study, an informed consent from the principal of the school as well as the parents of the students participating in the study was obtained.
The students were selected keeping in mind that they had almost similar socioeconomic status, dietary habits, oral hygiene methods, oral hygiene status and KAP status.
Children had a minimum of 1–2 established carious lesions.
The subjects were divided into three groups by block randomization: Group I (n = 514) - using Triphala mouthwash (0.6%), Group II (n = 495) – using chlorhexidine mouthwash (0.1%) [Positive control] and Group III (n = 492) – using Distilled water [Negative control].
The schools were distributed in such a manner so that there was no intermingling within the students of different groups. The group allotment was done in such a manner that the investigators and teachers, who were trained to administer the mouthwash, did not know the content of the bottles. Also, the subjects were not told about the content of mouthwash to make this study a complete double-blind clinical trial.
The caries status was assessed using the DMFS index[3
] (DMF is index for recording dental caries in permanant teeth whereas dmf is index recording dental caries in primary / milk teeth) and incipient caries using the DSi index as suggested by Bjarnason, Kohler and Ranggard.[4
Dental caries for DMFS index was diagnosed based on the following criteria:
- The lesion was clinically visible and obvious.
- The explorer tip could penetrate deep into soft yielding material.
- There was discoloration or loss of translucency typical of undermined or demineralized enamel.
- The explorer tip got caught in a pit or fissure or resisted removal after moderate to firm pressure on insertion.
For posterior teeth five surfaces were examined and for anterior teeth four surfaces were examined.
Incipient caries for DSi index was diagnosed visually under proper light after drying the tooth surface with cotton. It appeared as white chalky area when dried and was not visible when moistened with saliva.
Approximately 0.6% Triphala mouthwash, 0.1% chlorhexidine mouthwash and distilled water were prepared in the pharmacy manufacturing unit of the hospital. All solutions were made of identical colors to eliminate bias. The bottles were then coded and then at the end of the study, the decoding was done.
The indices were recorded before commencement of the study. After collecting the baseline data, plaque and gingivitis scores were brought to zero. Mouth rinsing was started on the day of performing the oral prophylaxis. The teachers were educated and trained in the use of mouthwash so that the children , under the supervision of the teachers, could use the mouthwash. Each of the groups used the respective mouthwash, as a daily, supervised rinse after lunch in the afternoon. The children were advised not to eat or rinse for the next 30 minutes. They were instructed to carry home the mouthwash bottles on weekends and during vacations.
Ten milliliters of mouthwashes were dispensed at one time. The mouthwash was swished in all quadrants of the mouth for a period of two minutes.
The Dsi (incipient caries) were done at 3, 6 and 9 months intervals from baseline and the caries assessment was done at 9 months interval from baseline.
For intra-group comparison of the paired sample, t-test was applied, while for the inter-group comparison independent t-test was applied. All the tests were carried out using SPSS package in the computer.