In situ anticaries efficacy of dentifrices with different formulations - A pooled analysis of results from three randomized clinical trials.

OBJECTIVES: Data generated from three similar in situ caries crossover studies presented the opportunity to conduct a pooled analysis to investigate how dentifrice formulations with different fluoride salts and combinations at concentrations of 1400-1450 ppm F, different abrasive systems and in some cases, carbomer (Carb), affect enamel caries lesion remineralization and fluoridation. METHODS: Subjects continuously wore modified partial dentures holding two gauze-covered partially-demineralized human enamel specimens for 14 days and brushed 2×/day with their assigned dentifrice: Study 1: sodium fluoride (NaF)/Carb/silica, NaF/silica, NaF + monofluorophosphate (MFP)/chalk; Study 2: NaF/Carb/silica, NaF + MFP/dical, amine fluoride (AmF)/silica; Study 3: NaF/Carb/silica, NaF + stannous fluoride (SnF2)/silica/hexametaphosphate (HMP). All studies included Placebo (0 ppm F) and/or dose-response controls (675 ppm F as NaF [675F-NaF]) ±Carb. Specimens were evaluated for percentage surface microhardness recovery (SMHR) and enamel fluoride uptake (EFU). RESULTS: All 1400-1450 ppm F dentifrices except NaF + SnF2/silica/HMP provided significantly greater lesion remineralization than Placebo (p < 0.0001): differences in SMHR ranged from 17.46% (NaF + MFP/dical) to 26.66% (AmF/silica). For EFU (back-transformed log EFU), all 1400-1450 ppm F dentifrices gave significant fluoride uptake compared to Placebo (p < 0.0001): increases in EFU ranged from 4.95 µg F/cm2 (NaF + SnF2/silica/HMP) to 16.32 µg F/cm2 (NaF/carb/silica). Dentifrices containing NaF or AmF as sole fluoride source provided the greatest remineralization and fluoridation; Carb addition did not alter fluoride efficacy; some excipients appeared to interfere with the cariostatic action of fluoride. Treatments were generally well-tolerated with ≤4 treatment-related adverse events per study. CONCLUSION: Commercially available fluoride dentifrices varied greatly in their ability to remineralize and fluoridate early caries lesions. CLINICAL SIGNIFICANCE: Fluoride dentifrices are the most impactful anticaries modality worldwide. While clinical caries trials have not consistently shown the superiority of one formulation over another, these findings using a sensitive in situ caries model indicated that dentifrices containing NaF or AmF as the sole fluoride source provided the greatest remineralization and fluoridation benefits.

A randomised clinical study to evaluate experimental children's toothpastes in an in-situ palatal caries model in children aged 11-14 years.

OBJECTIVES: To compare three children's sodium fluoride toothpastes to placebo with respect to enamel remineralisation potential, enamel fluoride uptake and net acid resistance using an in situ palatal caries model in children aged 11-14 years following a single brushing. DESIGN: This was a randomised, single blind (laboratory analyst), single-centre, four-treatment, crossover study with a 7-day washout period between treatments. The treatments were 1,426 ppm fluoride, 1,000 ppm fluoride, 500 ppm fluoride and 0 ppm fluoride (placebo) toothpaste (NaF/silica). A custom made in situ palatal appliance was used by each subject in all treatment periods. At each of the four treatment visits subjects wore the appliance containing four partially demineralised human enamel specimens for 5 minutes and then brushed their teeth using a standardised procedure for 60 seconds under supervision using 1.0 g (±0.1 g) of their assigned toothpaste. After 4 hours the appliance was removed and enamel specimen recovered. This process was repeated until all subjects completed all four study treatment visits. Recovered enamel specimens were analysed for per cent surface microhardness recovery (%SMHR; Knoop) and enamel fluoride uptake (EFU; microdrill biopsy). Subsequently, specimens were demineralised in vitro to determine their % net acid resistance (%NAR; Knoop). RESULTS: All three fluoride toothpastes demonstrated significantly greater %SMHR, EFU and %NAR compared with 0 ppm F toothpaste. The model demonstrated a dose response over the range 0 to 1,426 ppm fluoride for %SMHR, EFU and %NAR. There was no significant difference between 500 ppm F and 1,000 ppm F for %SMHR and between 1,000 ppm F and 1,426 ppm F for %SMHR, EFU and %NAR. CONCLUSIONS: The present in situ study demonstrated that the children's fluoride toothpastes tested are capable of delivering cariostatic amounts of fluoride to early caries lesions following a single brushing.

A randomised clinical study to evaluate the effect of brushing duration on fluoride levels in dental biofilm fluid and saliva in children aged 4-5 years.

OBJECTIVES: To compare the effect of 40 seconds versus 2 minutes brushing on saliva and dental biofilm fluid fluoride in children ages 4-5 years over 1 hour. DESIGN: This was a single-blind, cross-over, randomised, two-period clinical study in healthy children. Three days before the start of each treatment subjects received a thorough brushing and then refrained from all oral hygiene procedures. At treatment visits, after collecting baseline biofilm and saliva samples, staff brushed the occlusal surfaces of the subject's posterior teeth with a pea-sized amount (0.25 g) of NaF/silica toothpaste for the randomised time. Samples were taken at 5 minutes, 15 minutes, 30 minutes and 60 minutes after brushing and analysed for fluoride using a microanalytical methodology. There was a minimum 4-day washout period between treatments. RESULTS: Log changes from baseline biofilm fluid and saliva fluoride were statistically significant (P < 0.05) for both brushing times at all post-brushing time-points [except 60 minutes saliva where P = 0.06 (t-test)]. Statistically significantly greater ln-AUC (area under the curve) was found for biofilm fluid and salivary fluoride after brushing for 2 minutes compared with brushing for 40 seconds over the 1-hour test period. There was a statistically significantly higher concentration of fluoride in the log change from baseline saliva levels after 5, 15, 30 and 60 minutes for the 2-minute brushing time compared with 40 seconds brushing time. There was no statistically significant difference in concentration of log change from baseline fluoride levels in biofilm fluid at each individual time-point (5, 15, 30 and 60 minutes) for the 2-minute brushing time compared with the 40-second brushing time, but significant differences were observed for 15, 30 and 60 minutes in favour of 2-minute brushing time when log biofilm fluid value was analysed. CONCLUSION: The findings provide further evidence for the benefits of increased duration of brushing with respect to fluoride delivery.

Quantification of gingival contour and volume from digital impressions as a novel method for assessing gingival health.

OBJECTIVE: To evaluate the novel assessment of gingival contour volume measurement from digital impressions compared with traditional clinical indices (Modified Gingival Index and Bleeding Index) and oral microflora following a dental prophylaxis. METHODS: Following baseline examinations and full mouth digital impression using the LAVA™ Oral Chairside Scanner (COS), subjects had one maxillary quadrant and the contra-lateral mandibular quadrant randomly allocated to receive a complete dental prophylaxis. Subjects then brushed twice daily at home using a standard toothpaste. After 1, 2, 4, 6 and 12 weeks gingivitis examinations and digital impressions of the maxillary and mandibular arches were taken. RESULTS: Significant improvements in gingivitis for the prophylaxis versus no prophylaxis quadrants were observed up to six weeks using both the traditional gingivitis indices and the assessment of change in gingival contour volume from the digital impressions. CONCLUSION: The assessment of changes in gingival contour volume may be a promising technique for the objective and quantitative clinical evaluation of products or procedures used to treat gingivitis. The effects of a dental prophylaxis were demonstrated by both this novel measure and traditional clinical indices.

A randomised clinical trial to assess maintenance of gingival health by a novel dentifrice containing 0.1%w/w o-cymen-5-ol and 0.6%w/w zinc chloride.

OBJECTIVES: To assess the ability of 0.1%w/w o-cymen-5-ol/ 0.6%w/w zinc chloride dentifrice to maintain gingival health compared to a sodium fluoride control dentifrice. DESIGN: Following a baseline examination, subjects went through a regimen to bring them to a high level of gingival health. This included a professional prophylaxis supported by oral hygiene instruction prior to commencing study treatment. Subjects brushed twice daily for 12 weeks with either the test or control dentifrice. Examinations for gingival inflammation (MGI), bleeding and plaque were performed after 6 and 12 weeks. RESULTS: 224 subjects were included in the efficacy analysis. Relative to the sodium fluoride/ silica control dentifrice group the o-cymen-5-ol/ zinc chloride dentifrice exhibited statistically significant reductions (p<0.0001) in MGI, bleeding and plaque of 12.3%, 18.5% and 13.2% respectively after six weeks and 38.1%, 37.8% and 24.2% after 12 weeks. CONCLUSION: The results of the present clinical study demonstrate that the use of the 0.1%w/w o-cymen-5-ol/ 0.6%w/w zinc chloride dentifrice over a 12 week period provides a statistically significant benefit in maintaining gingival health compared to a sodium fluoride control dentifrice.

A randomised clinical trial to assess maintenance of gingival health by a novel gel to foam dentifrice containing 0.1%w/w o-cymen-5-ol, 0.6%w/w zinc chloride.

OBJECTIVES: To assess the ability of 0.1%w/w o-cymen-5-ol/ 0.6%w/w zinc chloride gel to foam dentifrice to maintain gingival health compared to a sodium fluoride control dentifrice. DESIGN: Following a baseline examination, subjects went through a regimen to bring them to a high level of gingival health. This involved a professional dental prophylaxis supported by oral hygiene instruction prior to commencing study treatment. Subjects brushed twice daily for 12 weeks with either the test or control dentifrice. Examinations for gingival inflammation (MGI), bleeding and plaque were performed after 12 weeks. RESULTS: 205 subjects were included in the efficacy analysis. Relative to the sodium fluoride/ silica control dentifrice group the o-cymen-5-ol/ zinc chloride gel to foam dentifrice exhibited statistically significant reductions (p<0.0001) in MGI, bleeding and plaque of 32.2%, 26.3% and 20.7% respectively after 12 weeks. CONCLUSION: The results of the present clinical study demonstrate that the use of the 0.1%w/w o-cymen-5-ol/ 0.6%w/w zinc chloride gel to foam dentifrice over a 12 week period provides a statistically significant benefit in maintaining gingival health compared to a sodium fluoride control dentifrice.

Laboratory assessment of the anticaries potential of a new dentifrice.

OBJECTIVE: The aim of the present study was to investigate the anticaries potential of a new sodium fluoride dentifrice in comparison to two commercial dentifrices containing different fluoride compounds by determining enamel fluoride uptake (EFU) and early caries lesion remineralization (REM) in an established in vitro caries remineralization/demineralization pH cycling model. METHODS: Test products were: new dentifrice formulation in a fluoride dose-response (0; 675; 1426 ppm F as sodium fluoride [NaF-0; NaF-675; NaF]); Elmex Kariesschutz (1400 ppm F as amine fluoride [AmF]); and Oral-B Pro-Expert (1450 ppm F-1100 ppm F as stannous fluoride and 350 ppm F as sodium fluoride [SnNaF]). Artificial caries-like lesions were formed in human enamel specimens by immersion in lactic acid buffer (LA). Specimens were then subjected to a daily cycling regime for 20 days comprising four one-minute dentifrice slurry treatments (prepared in pooled human saliva), and one four-hour LA challenge and remineralization in pooled human saliva. After 20 days, REM was evaluated as the change in surface Vickers microhardness from lesion baseline and EFU using the microdrill technique. The data were analyzed using ANOVA. RESULTS: A good fluoride dose-response was established for EFU and REM, with NaF delivering greater EFU and REM than NaF-675, which was superior to NaF-0 (p < 0.05). The new dentifrice NaF also showed greater EFU and REM than AmF and SnNaF (p < 0.05). In EFU, AmF and SnNaF were as efficacious as NaF-675 and superior to NaF-0 (p < 0.05). AmF and NaF-675 were also comparable in REM, whereas both products exhibited superior REM vs. SnNaF (p < 0.05), which was superior to NaF-0 (p < 0.05). CONCLUSION: The present study has demonstrated that fluoride dentifrices vary in their capability of enhancing anticaries potential as determined using an established in vitro caries cycling model. The new dentifrice NaF showed superior predicted anticaries potential compared to the two commercial dentifrices AmF and SnNaF in this model, which demonstrates the importance of fluoride compound and formulation excipients on driving anticaries potential in vitro.

Control of oral malodour by dentifrices measured by gas chromatography.

OBJECTIVE: To evaluate the effect of toothpaste treatments on levels of oral volatile sulphur compounds (VSCs) measured by gas chromatography in two clinical studies. METHODS: These were blinded, randomised, controlled, crossover studies with 16 (study A) or 20 (study B) healthy volunteers between the ages of 19-54. Study A: breath samples were collected at baseline, immediately and lhr after brushing. Four dentifrices (Zinc A, Zinc B, commercially available triclosan dentifrice and zinc free control) were evaluated. Study B: breath samples were collected at baseline, immediately, 1, 2, 3 and 7 hours after treatment. Subjects consumed a light breakfast then provided an additional breath sample between baseline assessment and treatment. Two dentifrices (gel-to-foam and a commercially available triclosan dentrifrice) were evaluated. Breath samples were collected in syringes and analysed for VSCs (hydrogen sulphide, methyl mercaptan and Total VSCs) utilising gas chromatography (GC) with flame photometric detection. RESULTS: Study A: immediately after treatment, a statistically significant reduction in VSCs from baseline was observed for Zinc A product only. A statistically significant reduction in VSCs from baseline was observed after 1 hour for all products. Both zinc products exhibited a significantly greater reduction from baseline VSCs than Colgate Total and Control at all time points. Study B: a statistically significant reduction in VSCs from baseline was observed at all time points for both products. The gel-to-foam product exhibited significantly greater reduction from baseline Total VSC concentration than Colgate Total at all time points from 1 hour post-treatment. CONCLUSION: Control of oral malodour by toothpaste treatment, evaluated as VSC levels using GC, has been demonstrated. Zinc is effective at reducing VSCs and the efficacy of zinc is formulation dependent. A gel-to-foam dentifrice was more effective at reducing VSCs than Colgate Total up to 7 hours.