A randomized controlled trial evaluating the efficacy of a 67% sodium bicarbonate toothpaste on gingivitis.

INTRODUCTION: In previous studies, toothpastes with high levels of sodium bicarbonate (>50%) have reduced gingival inflammation and oral malodour. This study compared the effects of brushing for 6 weeks with 67% (test group) or 0% (control group) sodium bicarbonate toothpaste on gingival health. METHODS: This was a single-centre, single examiner-blind, randomized, controlled, two-treatment, parallel-group study. Eligible subjects (≥18 years) had ≥20 gradable teeth, mild-to-moderate gingivitis, a positive response to bleeding on brushing and ≥20 bleeding sites. The primary objective was to compare the number of bleeding sites following twice-daily use of 67% sodium bicarbonate toothpaste or 0% sodium bicarbonate toothpaste after 6 weeks. Secondary endpoints included Modified Gingival Index (MGI), Bleeding Index (BI) and volatile sulphur compounds (VSC), assessed after 6 weeks. Safety was assessed by treatment-emergent oral soft tissue abnormalities and adverse events. RESULTS: Of 148 patients randomized (74 to each treatment), 66 (89.2%) completed the study in the test group, compared with 69 (93.2%) in the control group. Compared with the control group, the test group had a significant reduction in the number of bleeding sites at Week 6 (absolute difference - 11.0 [-14.0, -8.0], P < 0.0001; relative difference - 25.4%), together with significant reductions in MGI and BI (both P < 0.0001). Although the median reductions from baseline for VSC were numerically greater in the test group, the difference did not reach statistical significance (P = 0.9701). CONCLUSIONS: This 67% sodium bicarbonate toothpaste provided statistically significant improvements in gingival health and bleeding after 6 weeks of use.

Effect of toothbrushing duration and dentifrice quantity on enamel remineralisation: An in situ randomized clinical trial.

OBJECTIVES: The influence of toothbrushing duration and dentifrice quantity on fluoride efficacy against dental caries is poorly understood. This study investigated effects of these two oral hygiene factors on enamel remineralisation (measured as surface microhardness recovery [SMHR]), enamel fluoride uptake (EFU), and net acid resistance (NAR) post-remineralisation in a randomized clinical study using an in situ caries model. METHODS: Subjects (n=63) wore their partial dentures holding partially demineralised human enamel specimens and brushed twice-daily for two weeks, following each of five regimens: brushing for 120 or 45s with 1.5g of 1150ppm F (as NaF) dentifrice; for 120 or 45s with 0.5g of this dentifrice; and for 120s with 1.5g of 250ppm F (NaF) dentifrice. RESULTS: Comparing brushing for 120s against brushing for 45s, SMHR and EFU increased by 20.0% and 26.9% respectively when 1.5g dentifrice was used; and by 22.8% and 19.9% respectively when 0.5g dentifrice was used. Comparing brushing with 1.5g against brushing with 0.5g dentifrice, SMHR and EFU increased by 35.3% and 51.3% respectively when brushing for 120s, and by 38.4% and 43.0% respectively when brushing for 45s. Increasing brushing duration and dentifrice quantity also increased the NAR value. The effects of these two oral hygiene factors on SMHR, EFU, and NAR were statistically significant (p<0.05 in all cases). CONCLUSION: Brushing duration and dentifrice quantity have the potential to influence the anti-caries effectiveness of fluoride dentifrices. Study NCT01563172 on ClinicalTrials.gov. CLINICAL SIGNIFICANCE: The effect of two key oral hygiene regimen factors - toothbrushing duration and dentifrice quantity - on fluoride's anticaries effectiveness is unclear. This 2-week home-use in situ remineralisation clinical study showed both these factors can influence fluoride bioactivity, and so can potentially affect fluoride's ability to protect against caries.

A randomised clinical study to evaluate the efficacy of alcohol-free or alcohol-containing mouthrinses with chlorhexidine on gingival bleeding.

OBJECTIVES: Gingival bleeding following twice-daily use of 0.2% w/v chlorhexidine digluconate mouthrinse with and without alcohol (0.2% CHX-alcohol; 0.2% CHX-alcohol-free, respectively) and brushing with a standard fluoride toothpaste was compared to brushing alone. METHODS: Three hundred and nineteen subjects with mild-to-moderate gingivitis (with ≥16 gradable permanent teeth including four molars, bleeding after brushing and ≥20 bleeding sites) completed this randomised, examiner-blinded, parallel-group study. A prophylaxis was performed at baseline. Gingival Severity Index (GSI; primary objective), Gingival Index (GI) and Plaque Index (PI) were assessed at baseline and after 6 weeks of treatment. Adverse events (AEs) were recorded throughout the study. RESULTS: Between treatment differences at week 6 demonstrated significantly lower GSI for the 0.2% CHX-alcohol and 0.2% CHX-alcohol-free groups compared to brushing alone (primary endpoint; treatment difference -0.061 [95% CI -0.081, -0.041] and -0.070 [95% CI -0.090, -0.050], respectively; both p <0.0001). There were also significant reductions in GI and PI for the 0.2% CHX-alcohol and 0.2% CHX-alcohol-free groups compared to brushing alone (all p <0.0001). The proportion of subjects reporting ≥1 treatment-related adverse events (TRAEs) was 27.8% (0.2% CHX-alcohol), 24.8% (0.2% CHX-alcohol-free) and 3.7% (brushing alone). CONCLUSIONS: Chlorhexidine mouthrinse with or without alcohol as an adjunct to brushing with regular fluoride toothpaste significantly reduces bleeding scores, plaque and gingival inflammation compared to brushing alone. TRAEs are characteristic of those associated with the use of chlorhexidine and are similar for both mouthrinses.

Dose-response effect of fluoride dentifrice on remineralisation and further demineralisation of erosive lesions: A randomised in situ clinical study.

OBJECTIVE: The objective was to evaluate the ability of fluoride in a conventional, non-specialised sodium fluoride-silica dentifrice to promote tooth remineralisation and enamel fluoride uptake (EFU), and assess the resistance of the newly formed mineral to attack by dietary acid, across the concentration range used in mass-market dentifrices. METHODS: Subjects wore a palatal appliance containing eight polished bovine enamel specimens, each including an early erosive lesion. In a randomised full-crossover sequence, 62 healthy subjects were treated with dentifrices containing four different fluoride concentrations: no fluoride; 250ppm, 1150ppm and 1426ppm fluoride. At each treatment visit, under supervision, subjects brushed with 1.5g dentifrice and rinsed once while wearing the appliance; the appliance was removed after a 4-h remineralisation period and effects on the enamel specimens determined. The primary efficacy variable was surface microhardness recovery (SMHR); others included EFU, relative erosion resistance (RER) and comparative erosion resistance. RESULTS: Highly significant linear and, with the exception of SMHR, quadratic dose-response relationships were observed between all efficacy variables and fluoride concentration. For SMHR, EFU and RER, values for the different fluoride concentrations were statistically resolved from one another, with the exception of the two highest fluoride concentrations. The degree of remineralisation and the acid resistance of enamel after treatment were closely related to EFU. CONCLUSION: After a single brushing, conventional non-specialised sodium fluoride-silica dentifrices promoted remineralisation of early enamel lesions, and imparted increased acid-resistance to the enamel surface, in a dose-dependent manner at least up to 1500ppm fluoride. CLINICAL SIGNIFICANCE: Enamel erosive tissue loss is an increasing concern, associated with modern diets. This study demonstrated that sodium fluoride, in a conventional non-specialised dentifrice formulation, can promote repair of the earliest stages of enamel erosion after a single application, in a dose-dependent fashion across the fluoride concentration range used in mass-market dentifrices. This study is registered in the GlaxoSmithKline Study Register (ID RH01299), available at: www.gsk-clinicalstudyregister.com/study/RH01299.

Interproximal access efficacy of three manual toothbrushes with extended, x-angled or flat multitufted bristles.

PURPOSE: This laboratory research study was conducted to evaluate three manual toothbrushes for their ability to remove artificial plaque from interproximal sites. MATERIALS AND METHODS: Interproximal access efficacy (IAE) was evaluated using a pressure-sensitive artificial plaque substrate placed around simulated anterior and posterior teeth with horizontal and vertical brushing motions. Efficacy was determined as the maximum width of artificial plaque removed from around the teeth. Testing was conducted on three manual toothbrushes with different bristle configurations coded as: Extended [Aquafresh Between Teeth (also marketed as Dr. Best Zwischenzahn)], X-angled (Oral-B CrossAction) and Flat multitufted (Oral-B Indicator). Twenty-four tests on each toothbrush design were conducted, and the results were statistically analysed using two-sample t-tests, assuming unequal variances. RESULTS: The individual mean IAE values on anterior and posterior tooth shapes with vertical and horizontal brushing were significantly (P < 0.001) higher for the toothbrush with extended bristles (Aquafresh Between Teeth) than for the other two toothbrush designs tested. When the data were combined to give an overall average, the IAE for the toothbrush with extended bristles (Aquafresh Between Teeth) was significantly (P < 0.001) higher than the IAE value for the toothbrushes containing x-angled (Oral-B CrossAction) or flat multitufted bristles (Oral-B Indicator). CONCLUSION: Based on the demonstrated predictability of the IAE assay for clinical interproximal plaque removal, the manual toothbrush with extended bristles should be an effective brush for cleansing the dental interproximal sites.

The effect of brushing time and dentifrice quantity on fluoride delivery in vivo and enamel surface microhardness in situ.

While the clinical anticaries efficacy of fluoride toothpaste is now without question, our understanding of the relation of fluoride efficacy to brushing time and dentifrice quantity is limited. The aim of this in situ study was to determine how differences in brushing time and dentifrice quantity influence (i) fluoride distribution immediately after brushing, (ii) clearance of fluoride in saliva, (iii) enamel fluoride uptake (EFU) and (iv) enamel strengthening, via the increase in surface microhardness. The study compared brushing times of 30, 45, 60, 120 and 180 s with 1.5 g of dentifrice containing 1,100 microg/g fluoride as sodium fluoride. In addition, 60 s of brushing with 0.5 g dentifrice was evaluated. A longer brushing time progressively reduced retention of dentifrice in the brush, thereby increasing the amount delivered into the mouth. A longer brushing time also increased fluoride concentrations in saliva for at least 2 h after the conclusion of brushing, showing that increased contact time promoted fluoride retention in the oral cavity. There was a statistically significant positive linear relationship between brushing time and both enamel strengthening and EFU. Compared to 0.5 g dentifrice, brushing with 1.5 g dentifrice more than doubled the fluoride recovered in saliva after brushing and increased EFU. In conclusion, the results of this preliminary, short-term usage study suggest for the first time that both brushing time and dentifrice quantity may be important determinants both of fluoride retention in the oral cavity and consequent enamel remineralization.

A comparison of two chlorhexidine gel brushing regimens and a conventional toothpaste brushing regimen for the development of tooth staining over a 6-week period.

AIMS: A single-centre, randomized single-blind parallel study was undertaken to compare staining seen with three brushing regimens and to determine subject perception of side effects such as staining and effects on taste. METHODS: This 6-week parallel study used 157 volunteers who were randomized into one of three treatment groups: (i) brushing in the morning and evening with a normal dose of a 1% chlorhexidine gel, (ii) brushing with a low dose of chlorhexidine gel in the evening and a whitening dentifrice in the morning, and (iii) brushing with a standard fluoride paste in the morning and evening. Following home usage of their allocated products, the study volunteers returned after 3 and 6 weeks to record the amount of stain present. After the 6-week period, subject perception of taste and stain acceptability was determined using a questionnaire. RESULTS: After 6 weeks of use of the low-dose chlorhexidine gel and whitening dentifrice, significantly more stain was seen compared with the use of a standard dentifrice (P<0.0001). Similarly, significantly more stain was seen with use of the normal-dose chlorhexidine gel compared with the low-dose gel and whitening dentifrice (P=0.0007). Approximately 30% of individuals on the low-dose chlorhexidine gel regimen found the amount of stain unacceptable and 10% noted an effect on their taste perception. CONCLUSIONS: The use of low dose of chlorhexidine gel at night and a whitening paste in the morning produced a significant amount of stain that 30% of subjects considered unacceptable.

Clinical study to compare the effectiveness of a test whitening toothpaste with a commercial whitening toothpaste at inhibiting dental stain.

AIMS: A single centre, randomised single-blind, three-way crossover study was performed, to compare the effect of an experimental test toothpaste with a commercially available whitening toothpaste and water control at inhibiting extrinsic stain promoted by repeated chlorhexidine/tea rinses. METHODS: This study used 23 subjects. During the week before the study the subjects received a prophylaxis to remove all staining, plaque and calculus deposits. On the Monday of the following week subjects returned to the clinic to receive their rinses and to check their dentition was stain free. Under direct supervision at both 09:00 and 13:00 hours they rinsed with either a toothpaste slurry or water control that was repeated daily up to and including the following Thursday. Additionally from the Monday to the Thursday each subject rinsed with a 0.2% chlorhexidine mouthrinse, immediately followed by a rinse with a warm black tea solution. This cycle was repeated hourly eight times throughout the day and on the following days until the Friday. Throughout this period volunteers omitted all other forms of oral hygiene except rinsing with the chlorhexidine mouthwash. On the Friday the level of stain on the teeth and dorsum of tongue was assessed using the Lobene stain index for both stain area and intensity. At the end of each trial period each subject received a thorough prophylaxis to remove all plaque, calculus and staining before starting the second and third period of the study. RESULTS: As expected appreciable amounts of extrinsic stain accumulated on the teeth over each study period. The amount of stain following use of the toothpastes and water control was least with the experimental toothpaste, followed by water control and lastly the commercial whitening paste. For all sites combined there was evidence that the experimental paste was significantly superior to both the commercial paste and water control at reducing stain area (p<0.001), a product of stain area and intensity (p<0.001 and 0.05, respectively) but not stain intensity (p>0.05). CONCLUSIONS: In this stain-prevention model the use of an experimental paste showed a significant reduction in stain accumulation on the teeth compared with a (placebo) negative water control and a commercially available whitening paste. As such the experimental paste would be expected to be of benefit in controlling extrinsic dental staining.

Laboratory interproximal access efficacy of two toothbrushes with cross-angulated bristling.

Interproximal access efficacy (IAE) has been evaluated in a laboratory method using pressure-sensitive paper placed around simulated anterior and posterior teeth, using horizontal or vertical brushing motions. The two toothbrushes evaluated in this study were the Oral-B Cross Action Medium 40 and the Dr. Best X-Activ Mittel. Twenty-four tests on each toothbrush design were conducted, and results were statistically analyzed using ANOVA. In all of the individual evaluations, using either vertical or horizontal brushing motions on either anterior or posterior simulated teeth, the Dr. Best X-Activ Mittel toothbrush was significantly (p < 0.001) more effective than the Oral-B Cross Action Medium 40 in achieving IAE. When individual IAE data from the vertical, horizontal, anterior and posterior assessments were combined to assess overall IAE, the Dr. Best X-Activ Mittel toothbrush had a significantly (p < 0.001) higher mean value than the Oral-B Cross Action Medium 40 mean value.

Clinical efficacy of an optimized stannous fluoride dentifrice, Part 5: A 3-month study of extrinsic tooth staining, northeast USA.

The objective of this 3-month, double-blind clinical study was to investigate the level of tooth staining associated with the use of Colgate Optimized Stannous Fluoride (COSF) dentifrice compared to the tooth staining associated with two commercially available dentifrices. The results of this clinical study support the conclusion that the intensity and extent of extrinsic tooth stain associated with the use of the COSF dentifrice are significantly lower than that associated with Crest Gum Care Toothpaste. Further, this study provided no indication that the use of the COSF dentifrice is associated with a greater level of stain than that associated with the use of Crest Regular Toothpaste, a standard 0.243% sodium fluoride/silica dentifrice.

Clinical effects of a 0.12% chlorhexidine rinse as an adjunct to scaling and root planing.

This trial tested the adjunctive effects of a 0.12% chlorhexidine rinse (Peridex) upon gingival healing following scaling and root planing. Assessments were made on reduction in plaque (Pl), gingivitis (GI), pocket depth and gingival bleeding as measures of treatment benefit. All subjects had Class II, III or IV periodontal conditions. Following baseline examinations, subjects received a gross supragingival scaling and polishing. Subjects were separated by sex and periodontal classification, arrayed by GI scores, and randomly assigned to either the chlorhexidine rinse or a placebo rinse. Subjects were instructed to rinse with 1/2 ounce of their assigned products for 30 seconds twice daily. Following two weeks of product use, the clinical examinations were repeated and two randomly selected, opposing contralateral quadrants were scaled and root planed. After two more weeks of product use (week 4), clinical examinations were repeated and the remaining quadrants were scaled and root planed. At week 6, final clinical examinations were conducted. Since half-mouths were treated at different times and exposed to the treatment rinses for different periods, the data were analyzed for the half-mouths independently 2 and 4 weeks after gross scaling, and 2 and 4 weeks after root planing. A total of 94 subjects (47 in each treatment group) completed all phases of the trial. Gingival healing following scaling and root planing in subjects using a chlorhexidine rinse (0.12%) was significantly better than subjects using the placebo rinse as evidenced by less gingivitis (29%), fewer GI bleeding sites (48%) and less plaque (54%).

A comparison of 3 clinical indices for measuring gingivitis.

A clinical study was conducted among 200 adult males and females to compare the intrusive gingival index (GI) for estimating gingivitis with the nonintrusive and only visually applied papillary-marginal-gingivitis index (PMGI). The GI examinations were performed by a senior examiner with long experience and a junior examiner, while the PMGI was graded by only a senior examiner with long experience. A 4th examiner was included for grading bleeding sites by gentle intrusion at the orifice of the gingival crevice. Following the baseline examination by all examiners, the subjects were randomly assigned to either a group that received an oral prophylaxis immediately or to a group that received an oral prophylaxis 6 weeks after the baseline. All subjects were regraded by all examiners 4 days after the 2nd group received a prophylaxis. This delayed prophylaxis design created a difference in the responses between treatment groups. Both the GI examiners and the PMGI examiner concluded there was significantly less gingivitis in the group receiving a prophylaxis second. There were also significantly fewer bleeding sites in the group receiving a prophylaxis second as determined by both GI examiners and the bleeding-sites examiner.