Randomized controlled trial to evaluate tooth stain reduction with nicotine replacement gum during a smoking cessation program.

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.

Clinical study to monitor dentinal hypersensitivity with episodic use of a desensitising dentifrice.

OBJECTIVES/AIMS: To evaluate continuous and episodic twice-daily usage regimens of a desensitising dentifrice containing 5% calcium sodium phosphosilicate (CSPS). MATERIALS AND METHODS: In this exploratory, single-centre, randomised, examiner-blind study, subjects with dentinal hypersensitivity were randomised to continuous (24 weeks) use of a 5% CSPS-containing dentifrice or episodic use of the dentifrice comprising two 8-week treatment periods separated by 8 weeks' use of a standard fluoride dentifrice. Sensitivity was assessed by tactile threshold (Yeaple probe) and evaporative (air) sensitivity (Schiff sensitivity score). Other measures included labelled magnitude scales to assess subjects' responses to the evaporative stimulus, the Dentine Hypersensitivity Experience Questionnaire and a tooth sensitivity question. RESULTS: Seventy-six subjects were randomised to continuous (n=38) or episodic (n=38) use. Small but statistically significant improvements from baseline in Schiff sensitivity scores were observed at weeks 8, 16 and 24 with both regimens (all P<0.05). Increases from baseline in tactile threshold were not statistically significant. No significant between-regimen difference was observed for any endpoint. No treatment-related adverse events were reported. DISCUSSION: Dentifrice containing 5% CSPS improved dentinal hypersensitivity with both episodic and continuous twice-daily usage regimens over 24 weeks and was well tolerated. CONCLUSION: No performance differences were observed between the two usage regimens.