Randomized Clinical Study Comparing Three Experimental Denture Adhesives and Fixodent® versus No Adhesive.

OBJECTIVES: Denture adhesives can improve function, retention, stability, and bite force in well-fitting dentures. This single-center, randomized, five-arm, examiner-blind, crossover clinical study aimed to compare three experimental adhesives ("Adhesive 1," "Adhesive 2," "Adhesive 3") with slightly different formulations and a commercially marketed "Positive control" with a "No Adhesive" arm using incisal bite force measurements over 12 hours in subjects with a moderately well- to well-fitting maxillary denture. METHODS: Institutional review and informed consent were obtained and qualified subjects were randomly assigned to a treatment sequence. Prior to adhesive application, subjects were asked to bite on a transducer with increasing force until their maxillary denture dislodged (bite force measurement). This procedure was repeated at 0.5, 1, 3, 6, 9, and 12 hours after adhesive application, with results recorded electronically. Treatment differences in the area over baseline (AOB) were analyzed using an ANCOVA model. RESULTS: A total of 48 subjects completed the study. All experimental formulations showed statistically significantly higher bite force measurements compared to the No Adhesive arm at all time points (p < 0.0001 for Adhesive 1 and Adhesive 2 at all times; p < 0.003 for Adhesive 3 at all times). While numerical values for bite force favored the Positive control for the duration of the study, there were no significant statistical differences at any time point between Adhesive 2 and the Positive control, and only over three and six hours compared to Adhesive 1. However, differences favored the Positive control compared to Adhesive 3 at all time points. CONCLUSIONS: All denture adhesives gave statistically significantly better bite force AOB in moderately well- to well-fitting dentures compared to no adhesive. All denture adhesives tested were generally well tolerated.

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.

A randomized clinical trial in subjects with dry mouth evaluating subjective perceptions of an experimental oral gel, an oral rinse and a mouth spray compared to water.

PURPOSE: This multicenter, randomized, parallel group study analyzed the effectiveness of an experimental oral gel, a commercially available oral rinse and a commercially available mouth spray versus water alone at relieving self-reported symptoms of dry mouth over a 28-day home use treatment period. The effects of the study treatments on dry mouth-related quality of life (QoL) were also investigated. METHODS: Eligible subjects were stratified by dry mouth severity (mild, moderate or severe) and randomized to receive one of the study treatments. Prior to first use they completed a questionnaire designed to assess their baseline dry mouth-related QoL. Following first use and on Day 8 (2 hours post-treatment only) and Day 29, subjects completed the modified Product Performance and Attributes Questionnaire (PPAQ) I at 0.5, 1, 2 and 4 hours post-treatment. Subjects further assessed treatment performance using the PPAQ II questionnaire on Days 8 and 29 and the dry mouth-related QoL questionnaire on Day 29. RESULTS: In 396 randomized subjects almost all comparisons of responses to PPAQ I, including those for the primary endpoint (response to PPAQ I Question 1 'Relieving the discomfort of dry mouth' after 2 hours on Day 29), were statistically significant in favor of active treatment groups versus water (P < 0.05). All comparisons of responses to PPAQ II on Days 8 and 29 were statistically significant in favor of active treatments versus water (P < 0.05). Moreover, nearly all comparisons for dry mouth-related QoL scores on Day 29 were statistically significant in favor of the active treatments versus water. All the dry mouth management strategies in this trial were well tolerated.

Evaluation of the Oral Tolerance of Three Fluoride Toothpaste Formulations in a Dry Mouth Population: Results from Two Randomized Studies.

OBJECTIVES: To evaluate the oral tolerance of three experimental toothpaste formulations containing sodium fluoride (NaF), compared with two marketed sodium monofluorophosphate (SMFP)-containing biotène® toothpastes, in a dry mouth population after 14 days (primary objective) and 7 days (secondary objective) of use. METHODS: Toothpastes were tested in two separate dual-site, examiner-blind, randomized, parallel group studies in subjects (35-84 years) with self-reported dry mouth. Oral soft tissue (OST) and oral hard tissue (OHT) examinations were performed at screening, followed by a 7- to 28-day wash-in period using a control toothpaste. Subjects were randomized to receive a NaF-containing toothpaste (Study 1: commercially available toothpaste Pronamel® for Children, n = 82; Study 2: experimental plaque biofilm-loosening formula [PBF] toothpaste, n = 79; or experimental Gentle Mint toothpaste, n = 78) or a reference toothpaste (Study 1: biotène® Fresh Mint Original toothpaste [previously marketed formulation], n = 82; Study 2: biotène® Gentle Mint Gel toothpaste [previously marketed formulation], n = 77) during the 14-day treatment phase. Subjects brushed their teeth twice daily for one timed minute with a ribbon of toothpaste to cover the head of the toothbrush provided. Subjects received further OST and OHT examinations at Day 1 and Day 15, and an additional OST examination at Day 8. Adverse events (AEs) and serious AEs (SAEs) were reported throughout the study. RESULTS: Study 1: At Day 15, 42 oral treatment-emergent AEs (TEAEs) were reported in 33 subjects, of which seven in five subjects (commercially available toothpaste Pronamel for Children: n = 2; control: n = 3) were considered to be treatment-related. One SAE (dyspnea) was reported in a participant who was randomized but withdrew from the study before receiving the allocated toothpaste. Study 2: At Day 15, 41 oral TEAEs were reported in 38 subjects, of which two in two subjects (experimental Gentle Mint toothpaste: n = 1; control: n = 1) were considered treatment-related, according to the investigator. No SAEs were reported. CONCLUSIONS: In both studies, the experimental and reference toothpastes were well tolerated after 7 and 14 days of use. The experimental NaF-containing toothpastes offer potential alternatives to individuals with dry mouth.

Evaluation of the antiplaque efficacy of two cetylpyridinium chloride-containing mouthwashes.

OBJECTIVE: The purpose of this clinical study was to evaluate the efficacy in reducing dental plaque regrowth of two mouthwashes containing 0.075% cetylpyridinium chloride (CPC), one with 6% alcohol and one alcohol-free, as compared to a negative control mouthwash without CPC, using the Modified Gingival Margin Plaque Index (MGMPI). METHODS: The study was a double-blind, randomized, three-way crossover, controlled design. Following a washout period, subjects reported to the dental clinic where they were instructed to brush their teeth, used their assigned mouthwash, and were scored by the examining dentist for plaque using the MGMPI method. Subjects were instructed to refrain from all oral hygiene for the next 24 hours, except for rinsing with their assigned mouthwash 12 hours post-brushing. After this 24-hour period, subjects returned to the dental clinic and were once again scored for plaque. This sequence of washout followed by mouthwash use and plaque scoring was repeated until each subject had used all three mouthwashes. An ANOVA was conducted to assess between-group differences. RESULTS: The two test mouthwashes significantly reduced plaque regrowth over a 24-hour period (p < 0.05) as compared to the negative control mouthwash. The difference between the CPC-containing mouthwashes was not significant (p = 0.4868). CONCLUSION: Two mouthwashes containing 0.075% CPC, one with 6% alcohol and the other alcohol-free, were found to be safe and effective in reducing plaque accumulation when compared a negative control mouthwash without CPC. In short-term studies, the MGMPI appears useful for evaluating the antiplaque efficacy of mouthwash products.

Comparison of two over-the-counter tooth whitening products using a novel system.

Tooth whitening is one of the most widely accepted esthetic procedures in dentistry. Various treatment options include in-office and prescribed at-home bleaching procedures, over-the-counter bleaching kits, and whitening dentifrices. This study evaluated and compared a 6% hydrogen peroxide tooth bleaching gel delivered on polyethylene film (HP) with an 18% carbamide peroxide brush-applied liquid gel (CP). A total of 59 subjects completed this 2-week, examiner blind, randomized, parallel group study. Both treatments were applied twice daily for 2 weeks according to the manufacturer's instructions. Evaluations for oral safety and Vita tooth shade were conducted by a dental examiner at baseline and 2 weeks after product use. In addition, the ShadeVision System was used to determine changes in Vita shade and L*a*b* values. Based on both the examiner and ShadeVision System assessments, both treatments significantly improved tooth shade. Improvements in Vita tooth shade based on the adjusted mean for HP were 2.64 (P < 0.001) and 2.33 (P < 0.001) for the examiner and ShadeVision System assessments, respectively, compared with improvements of 1.04 (P = .004) and 0.42 (P = 0.029) for CP users, respectively. The difference between treatments was found to be significant for both the examiner (P = .005) and ShadeVision (P = .001) assessments. Findings from the L*a*b* data derived from the ShadeVision System were in agreement with Vita assessments, with significant differences for changes in L*, a*, and b* in favor of HP users (P = .001). In this study, the ShadeVision method of color analysis was relatively easy to use and demonstrated significant differences between 2 OTC whitening products using both Vitapan and L*a*b* means of assessment.

A 30-day clinical comparison of a novel interdental cleaning device and dental floss in the reduction of plaque and gingivitis.

OBJECTIVE: To compare the safety and efficacy of a novel battery-operated interdental cleaning device (Oral-B Hummingbird) [ID], fitted with either a flossette or pick attachment, versus hand-held dental floss in the reduction of plaque and gingivitis when combined with manual tooth brushing over a 30-day period. METHODOLOGY: This randomized, examiner blind, parallel group study assessed three treatment groups: ID/flossette (ID/F), ID/pick (ID/P), and unwaxed manual dental floss. All groups used the same soft manual toothbrush and toothpaste. The 84 subjects were stratified to treatment groups based on initial whole mouth mean plaque scores, gingivitis scores, and gender. Subjects were instructed to brush twice daily and use their assigned interdental method once daily in the evening before brushing. Gingivitis, gingival bleeding, and plaque were evaluated at baseline and Day 30. RESULTS: A total of 78 subjects completed all aspects of the study and were included in the analyses. There was no significant difference between treatment groups in baseline plaque, gingivitis, and bleeding scores. After 30 days, statistically significant reductions from baseline gingivitis and bleeding scores were found for all groups (p < 0.0001), but there were no significant statistical differences among groups. Whole mouth and approximal plaque scores were significantly reduced from baseline in the manual floss and ID/F groups after 30 days of product use, with no significant difference between groups. Plaque reduction for both the manual floss and ID/F groups was significantly greater than the ID/P group. All interdental cleaning methods were safe as used in the study, with no evidence of oral hard or soft tissue trauma. CONCLUSION: The Oral-B Hummingbird was safe and effective in reducing approximal plaque and gingival inflammation, and provides a useful alternative device for interdental cleaning.

A clinical study of plaque removal with an advanced rechargeable power toothbrush and a battery-operated device.

PURPOSE: To compare the safety and efficacy of two recently introduced modern power toothbrushes with different characteristics. MATERIALS AND METHODS: This was a single-blind, randomized, crossover study which compared the ability of two power toothbrushes to remove plaque during a 2-minute brushing period. The two brushes were the Braun Oral-B 3D Excel (D17), a rechargeable toothbrush with an oscillating/rotating/pulsating action and the Colgate Actibrush, a battery-operated device with an oscillating/rotating action. Seventy-four healthy subjects from a general population who met the inclusion/exclusion criteria used the two brushes on alternate days for a period of familiarization before returning to the test facility. At this visit, subjects with a whole mouth mean Proximal/Marginal Plaque Index of > or = 2.20 after 23-25 hours of no oral hygiene were randomly assigned to one of two treatment sequences, D17/Actibrush and Actibrush/D17, balanced for age and gender. Subjects brushed with their assigned toothbrush after which post-brushing plaque scores were recorded. After a 2-week washout phase subjects returned to the test facility and brushed with the alternate toothbrush as described. Data from the two visits were pooled, after which plaque removal efficacies were compared. Change from prebrushing treatment means were compared using ANOVA with models appropriate for the crossover design. RESULTS: Both toothbrushes were found to be safe and both significantly reduced plaque levels (P < or = 0.0001), but the D17 was significantly more effective than the Actibrush for the whole mouth and for approximal sites. Plaque reductions for the D17 were 46.5%, 55.2% and 42.9% for whole mouth, marginal and approximal sites, respectively while reductions for the Actibrush for the whole mouth, marginal, and approximal sites, were 41.5%, 52.5% and 36.8% respectively. It is concluded that the Braun Oral-B D17 may offer advantages in terms of plaque removal over the battery-powered Actibrush, particularly at hard to reach approximal sites.