Investigates the efficacy and tolerability of alcohol-free and alcohol-containing chlorhexidine mouthrinses.Discusses the pharmacokinetics of alcohol-free and alcohol-containing chlorhexidine mouthrinses after single and repeated use.

BackgroundDentine hypersensitivity can impact functional status and everyday activities such as eating and talking. This study aimed to assess changes in oral health-related quality of life measures in individuals with dentine hypersensitivity following long-term use (24 weeks) of a commercially available toothpaste marketed for dentine hypersensitivity relief.MethodsThis study was conducted across two sites and enrolled 75 adults with ≥2 non-adjacent sensitive teeth. Participants were assigned to twice-daily brushing with toothpaste containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Every 4 weeks, participant-reported outcomes were assessed using the Dentine Hypersensitivity Experience Questionnaire (DHEQ), a condition specific oral health-related quality of life scale that has five domains and includes questions on social and emotional impact, restrictions, adaptations and effect on life overall. Responses to a clinically applied evaporative (air) stimulus were assessed using the examiner-observed Schiff sensitivity scale and Labelled Magnitude Scales (LMS), which included dentine hypersensitivity-specific descriptors of intensity, duration, tolerability and descriptive qualities of the participant’s response.ResultsParticipant-reported outcomes demonstrated reduction of the impact of dentine hypersensitivity over time on health-related quality of life, as measured by the DHEQ. This reached statistical significance from Week 8 onwards (p < 0.0001 versus baseline) for the Total DHEQ score, with scores continually decreasing at each timepoint. Most domain scores followed a similar pattern. Statistically significant reductions were also detected for the examiner-observed Schiff Sensitivity Scale scores at all timepoints (including at 4 weeks) (p < 0.05), which were mirrored by LMS responses. The toothpaste was generally well-tolerated.ConclusionsThese results show that long-term use of a sensitivity toothpaste containing 0.454% w/w stannous fluoride has a beneficial, ongoing, impact on the oral health-related quality of life of people with dentine hypersensitivity.Trial registrationThis study was registered at Clinicaltrials.gov (https://clinicaltrials.gov/ct2/show/NCT02752958) on April 27, 2016.

AimTo evaluate effects of a 0.454% stannous fluoride test toothpaste on dentine hypersensitivity (DH) applied by fingertip, then 3 days’ brushing, versus a sodium monofluorophosphate‐based control.Materials and MethodsIn three randomized clinical studies, DH was assessed using evaporative (Schiff scale) and tactile (Yeaple probe) stimuli. Participants applied toothpaste to two sensitive teeth by fingertip (60 s each); DH was re‐assessed, prior to brushing. Test treatment participants brushed their sensitive teeth, with all participants then brushing all teeth for ≥60 s, twice daily for 3 days. DH was re‐assessed. Data were analysed by study and then pooled.ResultsIn two studies, test treatment significantly reduced DH versus control treatment after fingertip application and 3 days’ brushing (both measures). In one study, both treatments significantly reduced DH without between‐treatment differences. Mean Schiff differences (95% confidence intervals) for fingertip/3d were as follows: Study 1: −0.09 (−0.280, 0.092)/ −0.18 (−0.442, 0.072); Study 2: −0.72 (−0.839, −0.610)/ −1.02 (−1.150, −0.882); and Study 3: −0.26 (−0.387, −0.123)/ −0.92 (−1.055, −0.793). Pooled analysis indicated test treatment significantly reduced DH versus control (both timepoints, both measures). Toothpastes were generally well‐tolerated.ConclusionStudies indicated that single, fingertip application of a SnF2 toothpaste reduced DH versus a control. DH relief increased over 3 days.

BackgroundGingivitis can develop as a reaction to dental plaque. It can be limited by curtailing plaque build-up through actions including tooth brushing and the use of medicinal mouthwashes, such as those containing chlorhexidine digluconate (CHX), that can reach parts of the mouth that may be missed when brushing. This study aimed to compare dental stain control of twice-daily brushing with a sodium fluoride (NaF) dentifrice containing 67 % sodium bicarbonate (NaHCO3) or a commercially available NaF silica dentifrice without NaHCO3, while using a mouthwash containing 0.2 % CHX.MethodsThis was a 6-week, randomised, two-site, examiner-blind, parallel-group study in healthy subjects with at least ‘mild’ stain levels on the facial surfaces of ≥4 teeth and ≥15 bleeding sites. Assessment was via modified Lobene Stain Index (MLSI), the score being the mean of stain intensity multiplied by area (MLSI [IxA]).ResultsOne hundred and fifty of 160 randomised subjects completed the study. There were no significant differences in Overall (facial and lingual) MLSI (IxA) scores between dentifrices. The Facial MLSI (IxA) was statistically significant at 6 weeks, favouring the 67 % NaHCO3 dentifrice (p = 0.0404). Post-hoc analysis, conducted due to a significant site interaction, found significant differences for all MLSI scores in favour of the 67 % NaHCO3 dentifrice at Site 1 (both weeks) but not Site 2.ConclusionsNo overall significant differences were found between a 67 and 0 % NaHCO3 dentifrice in controlling CHX stain; a significant difference on facial surfaces suggests advantage of the former on more accessible surfaces.Trial registrationThis study was registered at ClinicalTrials.gov (NCT01962493) on 10 October 2013 and was funded by GSK Consumer Healthcare.

Objectives: To evaluate a 0.454% stannous fluoride/5% sodium tripolyphosphate (STP) toothpaste’s ability to provide relief from dentinal hypersensitivity (DH) applied using ‘focused brushing.’ Materials and methods: In two randomised, examiner-blind, parallel-group studies, a SnF2/STP toothpaste was applied by brushing two selected sensitive teeth before 1 min whole-mouth brushing, compared to 1 min whole-mouth brushing only, with a negative control toothpaste. DH was assessed via evaporative (air) (Schiff scale) and tactile (Yeaple probe) stimuli after 7 and 14 d of twice-daily brushing. Results: In total, 141 (Study 1)/142 (Study 2) participants were randomised. In Study 1, the test treatment significantly reduced DH at 7/14 d versus baseline (7/14 d Schiff difference: −0.74 [−0.84,−0.65]/−1.39 [−1.54,−1.23]; tactile: 6.00 [4.88,7.13]/15.30 [13.34,17.26]); whereas the Control treatment did not (7/14 d Schiff difference −0.03 [−0.13,0.06]/−0.10 [−0.25,0.06]; tactile: 0.77 [−0.36,1.90]/0.77 [−1.20,2.74]). Differences between Test and Control were statistically significant (p < 0.0001 all cases). In Study 2, both treatments reduced DH compared to baseline by both measures, but there were no significant between-treatment differences. Toothpastes were generally well-tolerated. Discussion and conclusions: Previous studies and Study 1 support SnF2/5% STP toothpaste efficacy; Study 2 results may have been influenced by placebo/Hawthorne effects. DH study design needs to, where possible, negate such effects.