A randomized clinical study to assess the performance of a marketed denture adhesive in a model of food infiltration in healthy, edentulous adults.

OBJECTIVES: An optimized food infiltration methodology was utilized to assess the objective and subjective efficacy of a marketed denture adhesive regarding denture dislodgment and infiltration and perception of food particles under maxillary and mandibular dentures. A pilot study helped optimize methodologies before the efficacy study. MATERIALS AND METHODS: Participants were healthy adults (n =48 for both studies) with fair- to well-fitting and well-made full maxillary and mandibular dentures. In the pilot, groups were a denture adhesive applied in a conventional dabbed-on pattern, a denture adhesive applied in continuous strips, or no adhesive. In the efficacy study, groups were the Test denture adhesive (continuous strips pattern application) or no adhesive, employed in a crossover design. Food infiltration was investigated through measurement of peanut particle mass retrieved from under each denture (30-32 g chewed). No formal statistical testing was performed in the pilot. Statistical analysis in the efficacy study was performed using analysis of variance. Primary efficacy evaluation was combined peanut particle mass from both dentures. Secondary efficacy evaluations included peanut particle mass under separate dentures, participant-reported denture dislodgements, and awareness/rates of how bothersome peanut particles under dentures were. RESULTS: In the pilot, the median peanut particle mass was lower with either pattern application compared with no adhesive. In the efficacy study, peanut particle mass under combined dentures was lower with than without adhesive (geometric mean [product of values]: 5.56 vs. 29.13 mg) with a between-group geometric mean ratio (adhesive over no adhesive) of 0.19 (95% confidence interval: 0.12, 0.30) favoring the Test adhesive (p < .0001). Similar Test adhesive beneficial outcomes in both studies included significantly fewer denture dislodgements and awareness and how bothersome peanut particles under dentures were. Treatments were generally well-tolerated. CONCLUSIONS: These findings, including reduced peanut particle infiltration, fewer denture dislodgments, and lower ratings of bothersomeness, corroborate those studies investigating the benefits of denture adhesive in preventing food infiltration.

Understanding the impact of removable partial dentures on patients' lives and their attitudes to oral care.

Introduction Due to a rising prevalence of removable partial denture (RPD) use, there is an unmet need to explore the psychological impact on patient wellbeing.Aim To assess the psychological effects of consumers losing teeth and receiving partial dentures to better manage their needs.Design Four market research surveys, undertaken on behalf of GlaxoSmithKline Consumer Healthcare, are described.Setting Surveys were conducted across the US, Japan, Malaysia, Colombia, Brazil, Poland and Italy.Materials and methods Quantitative/qualitative methods were used to gain knowledge regarding patients' experiences living with partial dentures.Results In a global market research survey involving 3,952 RPD wearers (RPDWs), 54% said that losing teeth was difficult to accept, 40% were concerned about their appearance, 32% were embarrassed about wearing dentures and 62% wished that more oral care education was available when they were younger. In another survey of >1,000 RPDWs, self-esteem was negatively impacted in 51% of respondents and 57% reported anxiety around dental visits.Conclusions Global market research confirmed that RPDWs can have emotional and practical needs that are not well understood/documented by dental healthcare professionals (HCPs). Consumer research can enhance understanding of patients' needs by dental HCPs and provide suggestions about how they may address them.

A proof-of-principle bite force study using two experimental test denture adhesives and a currently marketed denture adhesive.

OBJECTIVES: This proof-of-principle, single-center, randomized, examiner-blind, crossover study compared two experimental polyvinyl acetate (PVA)-based denture adhesives (Test Adhesives 1 and 2) with a marketed reference polymethyl vinyl ether/maleic anhydride (PMV/MA)-based adhesive and no adhesive using incisal bite force area over baseline over 12 hr (AOB0-12 ) in participants with an at least moderately well-fitting complete maxillary denture. Previous in vitro studies suggested the experimental denture adhesives provided superior performance. MATERIALS AND METHODS: Participants were randomized to a treatment sequence such that each received each treatment once. Prior to treatment application (baseline) and at 0.5, 1, 3, 6, 9, and 12 hr following the application, participants bit on a force transducer until their maxillary denture dislodged. Between-treatment differences in AOB0-12 were analyzed using analysis of covariance. For study validity, the reference adhesive was compared with no adhesive. Participants were asked to rate sensory experiences and ease of denture removal. RESULTS: Twenty-three participants were included in the modified intent-to-treat population. Although Test Adhesives 1 and 2 had a higher mean AOB0-12 than no adhesive, differences were not statistically significant. No statistically significant difference was also found between the reference adhesive and no adhesive; hence, study validity was not attained. Participants did not report any clear differences between the test or reference adhesives in terms of taste or feel; however, dentures were easier to remove with the test adhesives versus reference. No treatment-related adverse events were reported. CONCLUSION: Neither the experimental PVA-based denture adhesives nor the PMV/MA-based reference product demonstrated a statistically significant difference in incisal bite force AOB0-12 compared with no adhesive. The reasons for these unexpected results is unclear; they suggest that findings of in vitro tests for denture adhesive performance are not always translated to in vivo performance (Clinicaltrials.gov: NCT02937870).

A randomized clinical study to evaluate the effect of denture adhesive application technique on food particle accumulation under dentures.

Food ingress under dentures is a common problem that may be reduced by denture adhesive use. The objective of this study was to explore the effect of the mode of application of a denture adhesive on reducing accumulation of food particles under dentures. This was a single-centre, controlled, single-blind, randomized, three-treatment, three-period, crossover study in participants with complete, removable well-fitting, well-made upper/lower dentures. Treatments were: 1) experimental denture adhesive application (test adhesive) applied with a precision applicator as continuous strips; 2) marketed denture adhesive (positive control) applied using a flat ribbon nozzle as dabs; 3) no adhesive. Food-occlusion testing was performed by assessing peanut particle migration under dentures with denture retention/stability evaluated using the Kapur Index (Olshan modification). Differences were assessed using an ANOVA model. Adhesive oozing and perceptions of the adhesives were assessed by questionnaire. All 83 randomized participants completed the study. There were no significant differences between positive control or test adhesives versus no adhesive, or between test adhesive and positive control, for mass of peanut particles recovered from dentures. Both adhesives had significantly higher retention and stability scores compared with no adhesive (all P < .01). Participants reported significantly higher scores for denture comfort, confidence, satisfaction and movement with both adhesives versus no adhesive (all P < .01). No differences in adhesive ooze were reported between adhesives. No adverse events were reported. In conclusion, there was no difference in performance, as measured by peanut particle mass recovered from upper/lower dentures, for the test adhesive, positive control and no adhesive.

A method development randomised clinical study investigating efficacy of an experimental oral rinse in providing long-term relief from dentinal hypersensitivity.

OBJECTIVES: To evaluate and compare clinical efficacy of a 1.5% dipotassium oxalate monohydrate (KOX)-containing oral rinse ('Test') for the relief of dentinal hypersensitivity (DH) against Negative Control and Placebo oral rinses, adjunctive to twice-daily brushing with a standard fluoride dentifrice, after 8 weeks. METHODS: This was a randomised, examiner blind, parallel-group, method development study in participants with DH, assessed at baseline and after 4 and 8 weeks by response to an evaporative (air) stimulus (evaluated by Schiff sensitivity score and a 10-point visual rating scale [VRS]) and a tactile stimulus (Yeaple probe). To boost compliance, study features included recruiting only regular oral rinse users, use of an oral rinse during acclimatisation, weekly supervised rinsing and twice-daily text reminders. RESULTS: After 8 weeks, adjusted mean change from baseline in Schiff sensitivity score was significantly lower in the Test rinse group (n=43) versus the Negative Control group (n=23) (difference: -1.22; 95% CI -1.657, -0.782); tactile threshold score was significantly higher in the Test rinse group compared to the Negative Control rinse (difference: 37.46g; 95% CI: 22.916, 51.995). Similar significant differences in Schiff/tactile scores were also demonstrated after 4 weeks use, after 4 and 8 weeks use as assessed by VRS and as compared to the Placebo rinse (n=23) in all instances. Study products were generally well tolerated. CONCLUSIONS: The Test rinse showed statistically significant improvements in DH compared to the Negative Control and Placebo rinses after 8 weeks twice daily use. Compliance with the rinsing regimen and study visits was excellent. CLINICAL SIGNIFICANCE: Additional compliance features incorporated into this dentinal hypersensitivity study - recruitment of regular oral rinse users only, acclimatisation rinse, weekly supervised rinsing at the study site, twice-daily text reminders - appear to have been of benefit to the overall study design as compliance was high, and primary and secondary objectives were met.

Efficacy of a dissolvable strip with calcium sodium phosphosilicate (NovaMin®) in providing rapid dentine hypersensitivity relief.

OBJECTIVE: To evaluate the efficacy of a dissolvable strip containing 15% w/w calcium sodium phosphosilicate (CSPS) (Novamin®) in providing rapid relief from dentine hypersensitivity (DH). METHODS: In this examiner-blind, proof-of-principle study, 120 healthy adults with DH were randomized 1:1 to the Test strip, professionally applied to facial surfaces of two selected teeth, or to No treatment. Sensitivity was assessed at baseline and 10min, 2h and 4h post-application in response to evaporative (air) and tactile stimuli (measured by Schiff sensitivity scale/a numeric rating scale and tactile threshold, respectively). Change from baseline was analyzed by ANCOVA. RESULTS: At 10min post-application, mean Schiff score change from baseline (primary endpoint) was statistically significant with the Test strip (-0.46; 95% confidence intervals [CI]: -0.563, -0.356; p<0.0001) but not with No treatment (-0.02; 95% CI: -0.119, 0.088; p=0.7664). The between-treatment group difference favored the Test strip (difference: -0.44; 95% CI: -0.591, -0.297; p<0.0001). Similar improvements with the Test strip were reported for all other evaporative (air) and tactile sensitivity endpoints (p<0.0001 vs no-treatment) at all timepoints (10min, 2h, 4h). Test strips were considered by most staff and participants slightly/moderately easy to apply (98%). Many participants rated the overall usage experience as "like moderately" (40%) or "like extremely" (20%). There were no treatment-related adverse events. CONCLUSION: This new CSPS-based technology may provide a novel treatment option for rapid relief from DH (Clinicaltrials.gov NCT02937623). CLINICAL SIGNIFICANCE: A dissolvable strip containing 15% w/w calcium sodium phosphosilicate (CSPS) demonstrated significantly greater dentine hypersensitivity reductions following a single application compared with no treatment. Strips were well-liked by participants and generally well tolerated. A strip containing CSPS, which dissolves within 10min, may provide rapid relief from dentine hypersensitivity.

A Randomized Clinical Trial to Measure Mouth Moisturization and Dry Mouth Relief in Dry Mouth Subjects Using Dry Mouth Products.

OBJECTIVES: This study examined ratings of two subjective aspects (moisturization and dry mouth relief) that may be changed following the use of dry mouth relief products (an oral gel, an oral rinse, or a mouth spray), in comparison to water over a period of four hours following a single supervised use on two separate occasions. METHODS: This was a single-center, two site, randomized, examiner blind, four treatment arm, stratified (by dry mouth screening score at baseline), parallel group study in healthy subjects with a self-reported feeling of dry mouth. Prior to product use, subjects rated their current subjective perception of moisturization and dry mouth on an 11-point scale. Subjects then rated the two questions immediately after product use and 30, 60, 90, 120, and 240 minutes later. At the 240-minute time point, subjects also rated global efficacy questions regarding "overall" and "long-lasting" moisturization and dry mouth relief, and overall product opinion. Subjects then used their assigned products at home for three days and the procedures were repeated on Day 4. RESULTS: In total, 300 subjects were randomized to treatment. Compared with water, all test products showed statistically significantly greater improvements over baseline on both Day 1 and Day 4 at most time points, on the area under the curve from baseline for the moisturization and dryness questions, and after 240 minutes for the global efficacy and overall opinion assessments (all p < 0.05). There was a statistically significant difference between the pre-dosing assessments on Day 1 versus Day 4 (p < 0.001) for both efficacy questions. Products were generally well-tolerated. CONCLUSIONS: Three different types of dry mouth relief products were shown to provide significant relief of dry mouth and increased feelings of moisturization compared to water using subjective questionnaires.

The lateral pterygoid muscle, a heterogeneous unit implicated in temporomandibular disorder: a literature review.

Based on its anatomical relationships, the lateral pterygoid muscle is strongly linked with the temporomandibular joint (TMJ). It plays a major role in mastication. Embryological, histological, and anatomical knowledge define the lateral pterygoid muscle as a single muscle with a penniform structure. The various results of electromyographic (EMG) studies describe a complex physiology with a chronological contraction of the layers during the masticatory cycle. The sequential contraction of the layers of the lateral pterygoid muscle is the result of a selective neuronal activation induced by the masticatory Central Pattern Generator (mCPG). This neurophysiological theory highlights the essential role of the reticular formation in oral motor control. The sensitivity of those neurological structures to chronic emotional stress is one of the possible explanations for the appearance of oral parafunctions accompanied by a modification of pain perception and a disorganized muscular activation, determining factors in temporomandibular disorders.