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Logo of bmcorhlBioMed Centralsearchsubmit a manuscriptregisterthis articleBMC Oral Health
 
BMC Oral Health. 2012; 12: 13.
Published online Jun 13, 2012. doi:  10.1186/1472-6831-12-13
PMCID: PMC3444372
Randomized controlled trial to evaluate tooth stain reduction with nicotine replacement gum during a smoking cessation program
Helen Whelton,corresponding author1 Rose Kingston,1 Denis O’Mullane,1 and Frederick Nilsson2
1Oral Health Services Research Centre, University College Cork, Ireland
2Global Medical Affairs & Clinical Research, McNeil AB, Norrbroplatsen 2, SE-25109, Helsingborg, Sweden
corresponding authorCorresponding author.
Helen Whelton: h.whelton/at/ucc.ie; Rose Kingston: r.kingston/at/ucc.ie; Denis O’Mullane: d.omullane/at/ucc.ie; Frederick Nilsson: ekruse/at/its.jnj.com
Received September 7, 2011; Accepted May 23, 2012.
Abstract
Background
In addition to its general and periodontal health effects smoking causes tooth staining. Smoking cessation support interventions with an added stain removal or tooth whitening effect may increase motivation to quit smoking. Oral health professionals are well placed to provide smoking cessation advice and support to patients. The objective of the present study was to evaluate the effect of Nicorette® Freshmint Gum used in a smoking cessation programme administered in a dental setting, on extrinsic stain and tooth shade among smokers.
Methods
An evaluator-blinded, randomized, 12-week parallel-group controlled trial was conducted among 200 daily smokers motivated to quit smoking. Participants were randomised to use either the Nicorette® Freshmint Gum or Nicorette® Microtab (tablet). Tooth staining and shade were rated using the modified Lobene Stain Index and the Vita® Shade Guide at baseline, weeks 2, 6 and 12. To maintain consistency with other whitening studies, the primary end-point was the mean change in stain index between baseline and week 6. Secondary variables included changes in stain measurements and tooth shade at the other time points the number of gums or tablets used per day and throughout the trial period; and the number of cigarettes smoked per day. Treatments were compared using analysis of covariance (ANCOVA), using treatment and nicotine dependence as factors and the corresponding baseline measurement as a covariate. Each comparison (modified intention-to-treat) was tested at the 0.05 level, two-sided. Within-treatment changes from baseline were compared using a paired t-test.
Results
At week 6, the gum-group experienced a reduction in mean stain scores whilst the tablet-group experienced an increase with mean changes of -0.14 and +0.12 respectively, (p = 0.005, ANCOVA). The change in mean tooth shade scores was statistically significantly greater in the gum-group than in the tablet group at 2 (p = 0.015), 6 (p = 0.011) and 12 weeks (p = 0.003) with greater lightening in the gum-group at each examination period.
Conclusion
These results support the efficacy of the tested nicotine replacement gum in stain reduction and shade lightening. These findings may help dentists to motivate those wishing to quit smoking using a nicotine replacement gum.
Trial registration
NCT01440985
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