Effects of an oral hygiene regimen on progression of gingivitis/early periodontitis: A randomized controlled trial.

Background: Periodontal disease continues to be prevalent globally, but little clinical research has been undertaken to evaluate the long-term benefits of a daily oral hygiene regimen on progression of gingivitis/early periodontitis. The objective of this study was to evaluate the effects of an oral hygiene regimen (OHR) on the periodontal health of adults in good general health with established gingivitis and early periodontitis over 24 months. Methods: A randomized controlled trial was conducted in adults with established gingivitis, with isolated sites of probing pocket depth >4 mm. Study participants were randomized to the OHR (bioavailable stannous fluoride dentifrice, oscillating-rotating electric toothbrush, cetylpyridinium chloride rinse, and floss; P&G) or usual care products (sodium fluoride dentifrice and manual toothbrush; P&G) groups. At baseline and every 6 months, gingivitis and periodontal measures were assessed and a prophylaxis was conducted. The primary outcome was Gingival Bleeding Index-Bleeding Sites (GBI-BS). Analyses used ANCOVA at 5% significance levels. Results: A total of 107 individuals were enrolled; 87 completed the study. Mean GBI-BS, Modified Gingival Index, and Probing Pocket Depth (PPD) scores were significantly lower at each visit for the OHR versus usual care group by 28% to 39%, 12% to 18%, and 6% to 13%, respectively (p≤ 0.0009). The magnitude of reduction in median number of ≥2 mm PPD loss events for OHR versus the usual care group at 24 months was 74%. Conclusion: Long-term use of the OHR produced significant periodontal health improvements versus the usual care products.

Contexte: La maladie parodontale continue d'être prévalente sur le plan mondial, mais peu de recherches cliniques ont été effectuées pour évaluer les avantages à long terme d'un régime d'hygiène buccodentaire sur la progression de la gingivite ou de la parodontite précoce. L'objectif de cette étude était d'évaluer les effets d'un régime d'hygiène buccodentaire (RHB) sur la santé parodontale des adultes en bonne santé générale qui présentent une gingivite établie et une parodontite précoce au cours de 24 mois. Méthodologie: Un essai contrôlé randomisé a été effectué chez des adultes présentant une gingivite établie et des sites isolés de profondeurs de poches au sondage >4 mm. Les participants de l'étude ont été confiés à un groupe de RHB aléatoire (pâte dentifrice au fluorure stanneux biodisponible, une brosse à dents électrique rotative et oscillante, un rince-bouche au chlorure de cétylpyridinium et la soie dentaire; P & G) ou à un groupe de produits de soins habituels (dentifrice au fluorure de sodium et une brosse à dents manuelle; P & G). La gingivite et les mesures parodontales ont été évaluées au début de l'intervention et tous les 6 mois et une prophylaxie avait été effectuée. Le résultat primaire était l'Indice de saignement gingival­les sites de saignements (ISG­SS). L'analyse de covariance a été utilisée à des seuils de signification de 5 %. Résultats: Un total de 107 personnes ont été inscrites : 87 ont terminé l'étude. Les cotes moyennes de l'ISG­SS, de l'indice gingival modifié et des cotes de profondeurs des poches au sondage (PPS) étaient significativement plus faibles à chaque visite du groupe de RHB par rapport au groupe de soins habituels, de 28 % à 39 %, 12 % à 18 % et 6 % à 13 %, respectivement (p≤ 0,0009). L'ampleur de la réduction en nombre médian d'événements de perte de PPS ≥2 mm du groupe de RHB par rapport au groupe de soins habituels était de 74 % à 24 mois. Conclusion: L'utilisation à long terme du RHB a produit des améliorations significatives de la santé parodontale par rapport aux produits de soins habituels.

Clinical Parameters and Oral Fluid Biomarkers in Gingivitis Subjects using an Electric Toothbrush with Irrigator vs a Manual Toothbrush Alone over 8 Weeks: A Randomised Controlled Clinical Trial.

PURPOSE: To compare clinical outcomes and oral fluid biomarkers in gingivitis subjects using an electric toothbrush/irrigator combination (test) or a manual toothbrush alone (control) over 8 weeks. MATERIALS AND METHODS: Subjects were randomly assigned to two groups of n = 30. In both groups, toothbrushing was performed twice daily at home and no additional interdental cleaning aids were allowed. Plaque Index (PLI), Gingival Index (GI), whole saliva (WS), and gingival crevicular fluid (GCF) samples were collected at weeks 2, 4, and 8. RESULTS: Subjects' mean age was 23 years and 52% were female. Overall baseline means were 1.31 for PLI, 1.07 for GI, and 34.9 for number of bleeding sites. At every follow-up visit, both groups differed statistically significantly (p < 0.001) from baseline for all clinical parameters. The test group demonstrated statistically significantly (p < 0.001) greater reductions in GI vs the control group by 18% at week 2, 17% at week 4 and 24% at week 8. The test group also demonstrated statistically significantly (p < 0.002) greater reductions in the number of bleeding sites vs the control group by 33% at week 2, 34% at week 4 and 43% at week 8. Between-group comparisons for both WS and GCF revealed numerical trends for decreased levels of interleukin (IL)-1ß in GCF after 4 and 8 weeks, but these were not statistically significant. CONCLUSION: In subjects using the electric toothbrush/irrigator combination, increased clinical improvements may be found accompanied by similarly improved trends for oral fluid biomarkers such as IL-1ß.

A randomized controlled trial of a power brush/irrigator/mouthrinse routine on plaque and gingivitis reduction in orthodontic patients.

OBJECTIVES: To assess plaque and gingivitis reduction in orthodontic patients after 4 weeks' use of an oscillating-rotating power brush, irrigator, and mouthrinse. MATERIALS AND METHODS: This was a randomized, examiner-blind, clinical trial comparing plaque and gingivitis outcomes for an experimental power brush/irrigator/mouthrinse oral hygiene routine vs a dental prophylaxis followed by regular manual brushing (positive control). Fifty-one participants with fixed orthodontic appliances in the upper and lower jaw and a minimum of 15 gingival bleeding sites were randomly assigned to experimental or positive control treatment. Both groups were instructed to use their products at least twice daily. At baseline, week 1, and week 4, plaque was evaluated using digital plaque imaging analysis and a conventional subjective index. Gingival inflammation and bleeding were also measured. Analysis of covariance was used to compare groups. RESULTS: Fifty-one participants (mean age = 13.9 years) were randomized; 50 (25 per group) completed the study. At baseline, group means were not statistically different (P > .1) for gingival inflammation or bleeding. At week 4, the experimental and control groups had a 10.0% to 32.7% and 5.9% to 6.7% reduction vs baseline, respectively, in plaque (across both methods); 12.6% and 8.3% reduction, respectively, in gingival inflammation; and 50.6% and 37.8% reduction, respectively, in bleeding. At week 4, group differences favoring the experimental group were statistically significant (P < .05) for gingival inflammation, gingival bleeding, and plaque (by conventional and digital imaging indexes). CONCLUSIONS: Use of a power brush/irrigator/mouthrinse resulted in statistically significantly greater plaque and gingivitis reductions than prophylaxis followed by manual brushing in patients with fixed appliances over 4 weeks.

A Randomized Controlled Clinical Trial to Evaluate the Efficacy of an Oscillating-Rotating Electric Toothbrush, a Stannous Fluoride Dentifrice, and Floss on Gingivitis.

OBJECTIVES: To evaluate the gingival health efficacy of an oscillating-rotating electric toothbrush, a stannous fluoride dentifrice, and dental floss in adults with mild-to-moderate gingivitis. METHODS: This was a single-center, randomized, controlled, examiner-blind, two-treatment, eight-week parallel group study in adults with at least 20 gingival bleeding sites. Eligible subjects were randomized equally to one of two groups: experimental oral hygiene group that included an Oral-B® oscillating-rotating electric toothbrush with round brush head (D20/EB20), Crest® stabilized stannous fluoride dentifrice (SnF2 1100 ppm F, NaF 350 ppm F), and Oral-B® Glide® floss; or regular oral hygiene control group that included a regular manual toothbrush (Oral-B® Indicator 35) and Crest® anti-cavity sodium fluoride dentifrice (NaF 1450 ppm F). Subjects followed manufacturer's instructions and used their assigned products over an eight-week period. Gingival health was measured at baseline, Week 4, and Week 8 using three assessments: Gingival Bleeding Index (GBI), number of bleeding sites, and Modified Gingival Index (MGI). Analysis of Covariance was used to compare gingival health between treatment groups. RESULTS: One hundred and twenty subjects, mean age 44 years (range: 21 to 74 years), were assessed at baseline (60 per group); 113 subjects (57 in control group, 56 in experimental group) completed the study with fully evaluable data. At baseline, the groups were balanced; overall means were 0.41 for GBI, 51.7 for bleeding sites, and 1.44 for MGI. Only the experimental group showed statistically significant reductions from baseline (p < 0.0001) for all three gingivitis assessments at both Weeks 4 and 8. At these time points, better gingival health for the experimental group was seen as significantly lower adjusted mean scores versus the control group (p < 0.0001) for all three assessments. Reductions in favor of the experimental group at Weeks 4 and 8, respectively, were 51% and 45% for GBI, 46% and 40% for number of bleeding sites, and 37% and 20% for MGI. The study treatments were well tolerated. CONCLUSIONS: Over an eight-week period, an oral hygiene routine with an oscillating-rotating electric toothbrush, stannous fluoride dentifrice, and floss significantly improved gingivitis compared to regular hygiene with a manual toothbrush and an anti-cavity sodium fluoride dentifrice.

Relative Performance of Antisensitivity Dentifrice, Rinse, and Oxalate Strips: An In Vitro Comparison of Common Global Over-the-Counter Products.

OBJECTIVE: The objective of this research was to evaluate the performance of a polyethylene strip coated with an oxalate-containing gel to occlude patent tubuli in human dentin. METHODS: An in vitro model was adapted from the published literature to create a physiologically relevant microenvironment to study immediate and long-term effects of the strip. Observation techniques included scanning electron microscopy (SEM), SEM of ion-milled surfaces (SEM/FIB), and synchrotron-based x-ray microtomography. In addition, the reduction in hydraulic conductance induced by the strip was quantified. RESULTS: Significant deposition of crystalline oxalate was observed in treated dentin. Crystal density and occlusionary performance were found to be strong functions of strip application time and of the number of applications. Quantitative reduction in hydraulic conductance correlated well with crystal accumulation, also demonstrating a strong dependence on time and number of applications. The robustness of an oxalate crystal barrier formed with a single 10-minute strip application was tested over a 30-day period, during which dentin samples were subjected to a series of dissolution and mechanical challenges. Oxalate crystal density was shown to be modestly impacted, with substantial flow resistance maintained throughout the 30-day challenge period. CONCLUSION: The performance of an oxalate gel-coated strip is strongly affected by product-dentin contact time, producing an effective and durable occlusive barrier when applied as an adhesive strip.

Response of chronic gingivitis to hygiene therapy and experimental gingivitis. Clinical, microbiological and metabonomic changes.

PURPOSE: To compare the clinical, microbiological and metabonomic profiles of subjects with high and low levels of chronic gingival bleeding during a controlled oral hygiene regimen intervention including sequential phases of rigorous therapeutic oral hygiene followed by experimental gingivitis (EG). METHODS: Two cohorts of qualified study subjects with differences in gingival bleeding on probing levels at their baseline clinical examination were entered into the study. These two cohorts were followed through three separate study phases including a 1-week baseline phase, a 2-week phase of rigorous oral hygiene including dental prophylaxis, and a 3-week EG phase of no oral hygiene to encourage relapse of gingivitis. The 58 subjects were assessed during each phase of the study for clinical presentation of gingivitis and concurrently had plaque sampled for real-time polymerase chain reaction (RTPCR) microbiological characterization and salivary lavage samples for 'systems biology' metabonomics assessment by 1H-NMR. RESULTS: Subjects presenting with different levels of gingival bleeding on probing when they entered the study responded differently to rigorous oral hygiene and EG. Specifically, the high bleeding cohort responded sluggishly to rigorous oral hygiene and exhibited markedly greater relapse to gingivitis during EG. RTPCR analysis showed changes in bacterial populations that were associated with study phases, particularly the increases in putative periodontal pathogens during EG. However, the microbiological profiles of high- and low-susceptibility gingival bleeding patients were largely similar. Metabonomic analysis likewise revealed significant changes in metabolite composition during study phases associated with differences in plaque toxicity, especially the short chain carboxylic acids propionate and n-butyrate, which tracked clinical changes in gingivitis severity. Systems analysis of metabonomic changes suggested differences between cohorts, although analysis to date has not elucidated whether these differences are causative (population predictive) or simply diagnostic of clinical status within populations.

A clinical study to assess the effect of a stabilized stannous fluoride dentifrice on hypersensitivity relative to a marketed sodium fluoride/triclosan control.

OBJECTIVE: To evaluate the efficacy of a marketed stabilized stannous fluoride (SnF2) dentifrice in reducing dentinal hypersensitivity as compared to a marketed sodium fluoride (NaF)/triclosan dentifrice over an eight-week period. METHODS: Adults with confirmed dentinal hypersensitivity were enrolled in this randomized and controlled, parallel group, double blind, eight-week, single-center clinical trial. Random assignment to one of two dentifrice test groups via age, gender, and thermal sensitivity of enrolled test teeth was performed at baseline, with subjects assigned to twice-daily unsupervised brushing with either the marketed SnF2 dentifrice (Oral-B Pro-Expert, 0.454% SnF2 plus 0.077% NaF) or the marketed 0.32% NaF with 0.3% triclosan/copolymer dentifrice control (Colgate Total Advanced). Tactile sensitivity (Yeaple Probe) and thermal sensitivity (airblast/Schiff Air Index) evaluations of the selected test teeth were performed at baseline pre-treatment, and again at Weeks 2 and 8 of product use to compare the dentifrices' relative hypersensitivity protection effectiveness. RESULTS: Ninety-seven (97) of the 100 enrolled subjects completed the trial and were fully evaluable. At both Week 2 and Week 8, for both the thermal and tactile evaluation measurements, subjects brushing with the marketed SnF2 dentifrice experienced statistically significantly (p < 0.0001) superior average dentinal hypersensitivity improvement versus subjects assigned to the NaF/triclosan control dentifrice. Between groups, superior relative mean reduction in thermal Schiff Air Index favored SnF2 by 24% at Week 2 and 68% at Week 8, while greater relative mean tactile Yeaple Probe benefits were observed for SnF2 relative to the control by 114% after Week 2 and 184% at Week 8. The dentifrices were well-tolerated. CONCLUSION: Twice-daily brushing with a marketed SnF2 dentifrice provided superior dentinal hypersensitivity improvement versus a commercially available NaF/triclosan dentifrice, with significantly (p < 0.0001) greater relief after two weeks, and even larger relative benefits at eight weeks.

A randomized controlled clinical trial to assess the desensitizing effect of a stannous fluoride dentifrice.

PURPOSE: To assess the dentin hypersensitivity-reducing effectiveness of a 0.454% stannous-containing dentifrice as compared to a marketed negative control dentifrice after the first brushing as well as after 3 days and 2 weeks of twice daily use. METHODS: This was a 2-week, randomized, double-blind, parallel group, single-center clinical investigation in confirmed dentin hypersensitivity adult sufferers. At baseline, subjects were stratified by age, gender, and thermal sensitivity scores, and randomly assigned to a marketed 0.454% stannous fluoride (SnF2) dentifrice or a marketed sodium fluoride (NaF) dentifrice negative control. Following baseline assessment of tactile and thermal sensitivity via the Yeaple Probe and air-blast/Schiff Air Index evaluations, respectively, subjects brushed once on-site with their assigned test product following the same usage instructions. Post-brushing tactile and thermal sensitivity were then assessed ('Immediate' evaluation). Subjects subsequently brushed twice daily at home for a 2-week period, with the same tactile and thermal efficacy evaluations repeated at Day 3 and Week 2 post-baseline. RESULTS: All 116 enrolled subjects completed all evaluations. The stannous fluoride dentifrice provided significantly (P < 0.0001) superior dentin hypersensitivity reduction compared to the negative control dentifrice at each time point and by both evaluation measures: superior mean relative Yeaple Probe (tactile) benefits were 124.5% after one use, 203.8% after 3 days, and 222.5% after 2 weeks; and superior mean relative Schiff Air Index (thermal) benefits were 27.6% after a single use, 44.6% at Day 3, and 74.2% at Week 2. Both dentifrices were well-tolerated.

A randomised in situ trial, measuring the anti-erosive properties of a stannous-containing sodium fluoride dentifrice compared with a sodium fluoride/potassium nitrate dentifrice.

OBJECTIVES: To determine if a stabilised, stannous-containing sodium fluoride dentifrice provides greater enamel protection in situ against intraoral dietary erosive challenges compared with a sodium fluoride/potassium nitrate dentifrice. METHODS: A single-centre, investigator blind, randomised, supervised, two-treatment, non-brushing, four-period crossover in situ study was undertaken, with each test period being 15 days. Thirty-five healthy adult subjects were recruited to participate in the study, which included four erosive acid challenges per day. Subjects were randomised to product treatment, which included either: (1) a stannous-containing sodium fluoride dentifrice (Oral-B(®) Pro-Expert Sensitive) or (2) a sodium fluoride/potassium nitrate dentifrice (Sensodyne(®) Pronamel(®) ). Each study subject wore an intraoral appliance retaining two sterilised, polished human enamel samples for 6 hours/day. Subjects swished with an allocated dentifrice slurry twice a day and with 250 ml of orange juice for 10 minutes (25 ml/minute over a 10-minute period) four times per day. The primary and secondary outcomes for this study were enamel loss measured using contact profilometry at days 15 and 5, respectively, using parametric analysis methods. RESULTS: At day 15, a 38% lower enamel loss (P < 0.0001) was observed, with estimated medians of 2.03 µm (SE 0.247) and 3.30 µm (SE 0.379), in favour of the stannous-containing dentifrice. At day 5, specimens treated with the stannous-containing sodium fluoride dentifrice demonstrated 25% less enamel loss than those treated with the sodium fluoride/potassium nitrate dentifrice. Treatment differences at day 5 were also statistically significant (P < 0.05), with estimated medians of 1.37 µm (SE 0.177) and 1.83 µm (SE 0.223), respectively. CONCLUSIONS: Results of this in situ study suggest the stabilised, stannous-containing sodium fluoride dentifrice could be used to provide significantly greater protection to enamel from erosive acid challenge compared with that provided by conventional fluoride-containing products.

In situ clinical evaluation of a stabilised, stannous fluoride dentifrice.

OBJECTIVES: To compare the erosion protection efficacy of a stabilised, stannous fluoride (SnF2 ) dentifrice versus a sodium fluoride (NaF) dentifrice using a modified in situ clinical model. METHODS: This study, a randomised parallel group in situ design with in vivo product use and ex vivo acid challenge, compared: A, a dentifrice containing 1,450 ppm F as NaF; B, a dentifrice containing 1,450 ppm F (1,100 ppm F as SnF2 + 350 ppm F as NaF); and T, tap water. Sample size was n = 4 per group (total of 12 subjects) and within each subject appliances were placed on each side of the mouth (left and right). Enamel specimens were placed in different positions of the mouth (front, mid-front, mid-rear, rear) in each appliance (total = 8 specimens per subject). Product treatment was twice per day (lingual brushing for 30 seconds followed by swishing for 90 seconds with the resultant product/saliva slurry) in vivo for 15 days, and ex vivo acid treatment (0.02 m citric acid 5 minutes four times per day; total exposure time = 300 minutes). Data were analysed using a general linear repeated measures model with treatment, side and position as fixed effects. Within subjects, correlations were modelled assuming a different correlation and variance for treatment B relative to the other groups. Pairwise treatment differences were performed using a 5% two-sided significance level. RESULTS: Enamel loss (in µm) was significantly lower (P < 0.005) for treatment B versus treatments A and T. Treatment B reduced enamel surface loss by 86.9% relative to treatment A. There was no statistical difference in mean enamel loss (P = 0.51) between treatments A and T. Enamel loss was not statistically different for side (left vs. right; P = 0.44) or position (front, mid-front, mid-rear, rear; P = 0.36). CONCLUSION: This modified in situ erosion model confirmed the enhanced erosion protection benefits of a stabilised SnF2 dentifrice versus a conventional NaF dentifrice, validating the ability of the model to safely and effectively demonstrate differences in the erosion protection potential of oral care products.

Measuring enamel erosion: a comparative study of contact profilometry, non-contact profilometry and confocal laser scanning microscopy.

OBJECTIVES: To compare three instruments for their ability to quantify enamel loss after acid erosion. METHODS: 6 randomized parallel groups of bovine enamel samples were subjected to citric acid (higher acidity) or orange juice (lower acidity) erosion and remineralisation in a cycling model. Two protected shoulders were created on each of the samples using tape, to serve as reference for analysis. The time of exposure to each acid was varied, along with presence or absence of agitation. After treatment, samples were measured on 3 instruments capable of measuring step height: a contact profilometer (CP); a non-contact profilometer (NCP); and a confocal laser scanning microscope (CLSM) by three different examiners. Additionally, 3D (volume) step height was also measured using the CLSM. RESULTS: Increasing acid concentration and exposure time resulted in greater erosion, as did agitation of samples while in acid solution. All instruments/methods identified the same statistically significant (p<0.05) pair-wise differences between the treatments groups. Further, all four methods exhibited strong agreement (Intra-class correlation ≥ 0.96) in erosion level and were highly correlated, with correlations of 0.99 or higher in all cases. SIGNIFICANCE: All instruments/methods used in this study produced very similar conclusions with regard to ranking of enamel loss, with data showing very high agreement between instruments. All instruments were found to be equally suited to the measurement of enamel erosion.

Digital plaque imaging evaluation of a stabilized stannous fluoride dentifrice compared with a triclosan/copolymer dentifrice.

PURPOSE: To compare the relative plaque control efficacy of a marketed 0.454% stabilized stannous fluoride (SnF2) dentifrice relative to a triclosan/copolymer dentifrice using digital plaque imaging analysis (DPIA). METHODS: This was a randomized, two-treatment, double-blind, parallel group design study that compared SnF2 and triclosan/copolymer dentifrices over a period of 3 weeks. DPIA was used to capture a digital image of the maxillary and mandibular anterior facial surfaces of 12 teeth and to calculate plaque area coverage. Overnight DPIA images were taken at a baseline visit after which subjects were randomly assigned to one of the two treatment groups and were required to brush with their assigned dentifrice according to each manufacturer's instructions. Subjects had DPIA assessments on two separate days at the end of Week 3. RESULTS: 96 subjects were randomized to treatment. Plaque area data for 47 subjects per treatment group were compared at Week 3 using ANCOVA. The SnF2 group demonstrated a statistically significant reduction in overnight plaque at Week 3 compared to baseline (P= 0.002). The reduction for the triclosan group at Week 3 compared to baseline was not statistically significant (P= 0.24). At Week 3, the SnF2 group demonstrated a 17% lower adjusted mean for overnight plaque relative to the triclosan group with a mean difference that was statistically significant (P< 0.05). The Week 3 adjusted mean change from baseline in overnight plaque for the SnF2 group was 3 times greater versus that of the triclosan group (P< 0.05).

Evaluation of anti-gingivitis benefits of stannous fluoride dentifrice among triclosan dentifrice users.

PURPOSE: To evaluate the anti-gingivitis benefits of a 0.454% highly bioavailable stannous fluoride dentifrice (SnF2) relative to a 0.3% triclosan/copolymer dentifrice (triclosan/copolymer) among triclosan/copolymer dentifrice users with residual gingivitis. METHODS: This was a randomized, controlled, double-blind, parallel group, 2-month clinical study. Self-reported triclosan/copolymer dentifrice users were recruited and provided with triclosan/copolymer dentifrice to use for 1 month. After this 1-month acclimation period, subjects who had residual gingivitis at the baseline visit were randomized to either the SnF2 dentifrice or the triclosan/copolymer dentifrice (positive control). Subjects performed their treatment unsupervised using their assigned dentifrice following manufacturers' usage instructions for 2 months. The Gingival Bleeding Index (GBI) and Modified Gingival Index (MGI) were used to measure gingivitis benefits at baseline and Month 2. An analysis of covariance was performed to compare treatment groups for the post-baseline scores as well as change from baseline, with the baseline score as a covariate. All comparisons were two-sided at the 0.05 level of significance. RESULTS: A total of 150 subjects were randomized to treatment. Both treatment groups experienced significant reductions in number of bleeding sites, gingival bleeding index (GBI), and gingival inflammation (MGI) relative to baseline (P < 0.001). At Month 2, the SnF2 dentifrice group demonstrated significantly lower adjusted mean scores versus the triclosan/copolymer group for number of bleeding sites, GBI, and MGI (P < 0.001). Between-treatment group comparisons for change from baseline values showed that the improvement in number of bleeding sites from baseline for the SnF2 group was 49% greater versus that of the triclosan/copolymer group (P < 0.001), and the GBI and MGI improvements from baseline for the SnF2 group were 48% and 37%, greater, respectively, relative to the triclosan/copolymer group (P < 0.001).

Assessment of the effects of a stannous fluoride dentifrice on gingivitis in a two-month positive-controlled clinical study.

OBJECTIVE: The purpose of this study was to evaluate the anti-gingivitis effectiveness of a 0.454% stannous fluoride test dentifrice relative to a marketed positive-control triclosan-containing dentifrice in adults with gingivitis. METHODS: This was a two-month, randomized and controlled, double-blind, parallel group, single-center investigation involving 150 adults with existing mild to moderate gingivitis. Pre-treatment gingivitis levels were assessed at baseline using the Lobene Modified Gingival Index (MGI) and the Gingival Bleeding Index (GBI). Qualified subjects were randomly assigned to either a 0.454% stannous fluoride test dentifrice or a marketed, positive-control 0.30% triclosan/copolymer dentifrice. Subjects then brushed for two months unsupervised in the home setting with their assigned dentifrice per manufacturer's instructions. At Month 2, subjects were re-evaluated for gingivitis via MGI and GBI examinations. RESULTS: All 150 enrolled subjects completed the trial and were evaluable. Both the stannous fluoride test and triclosan/copolymer control dentifrices provided statistically significant reductions in average MGI, GBI, and number of bleeding sites relative to pre-treatment (p < 0.0001) at Month 2. The adjusted mean improvement from baseline at Month 2 for the stannous fluoride test dentifrice group was 65% greater for number of bleeding sites, 62% greater for GBI, and 45% greater for MGI compared to the triclosan/copolymer positive-control group, with groups differing significantly (p < 0.0001) via each of the three gingivitis measures. Both dentifrices were well-tolerated. CONCLUSION: An advanced stannous fluoride test dentifrice provided superior reductions in gingival inflammation and gingival bleeding compared to a commercially available triclosan/copolymer positive-control dentifrice after two months of tooth brushing.

Anti-gingivitis effects of a novel 0.454% stabilized stannous fluoride dentifrice relative to a positive control.

PURPOSE: To compare the anti-gingivitis efficacy of a novel 0.454% stannous fluoride dentifrice to a commercially available positive control triclosan-containing dentifrice in a population of adults with gingivitis. METHODS: This single-center, randomized and controlled, double-blind, parallel group, 2-month trial enrolled 200 adults with mild-to-moderate gingivitis. At baseline, pre-treatment gingivitis levels were assessed with both the Lobene Modified Gingival Index (MGI) and the Gingival Bleeding Index (GBI). Subjects were randomly assigned to one of two test dentifrices: either 0.454% highly bioavailable stannous fluoride or the 0.30% triclosan positive control. Following at-home, unsupervised toothbrushing according to manufacturer's instructions with their assigned test dentifrice for 2 months, subjects were re-evaluated for gingivitis again via the MGI and GBI examinations. RESULTS: A total of 196 subjects completed the trial and were evaluable. At Month 2, both test dentifrices produced statistically significant reductions in number of bleeding sites, GBI, and MGI on average relative to pre-treatment (P< 0.0001). The Month 2 adjusted mean improvement from baseline for the stannous fluoride dentifrice group was 62% greater for number of bleeding sites, 60% greater for GBI, and 45% greater for MGI versus the triclosan/copolymer positive control group; groups differed significantly (P<0.0001) for each gingivitis measure at Month 2. Both dentifrices were well-tolerated.

The Featherstone laboratory pH cycling model: a prospective, multi-site validation exercise.

PURPOSE: To demonstrate the robustness of the Featherstone pH cycling model when tested in three independent laboratories and to evaluate the use of "non-inferiority" testing at those laboratories. METHODS: The fundamental principles for the Featherstone laboratory pH cycling model to be an appropriate alternative to animal testing is that it must demonstrate equivalent accuracy to the "Gold Standard" (rat caries model) by: (1) providing a meaningful representation of the caries process; (2) demonstrating a proportionate response to fluoride dose (or concentration); (3) being able to show that clinically proven formulations perform similarly relative to the controls; and (4) differentiating products that have attenuated fluoride activity. RESULTS: This cross-validation study confirmed the ability of the three independent laboratories to discriminate between various concentrations of fluoride-containing dentifrice formulations, demonstrated that clinically proven formulas perform as expected and identified an attenuated fluoride formulation (NaF/CaCO3 dentifrice - 1100 ppm NaF) as inferior compared to the 1100 ppm F (NaF/silica) positive control.

Clinical trial assessing light enhancement of in-office tooth whitening.

OBJECTIVE: Evaluate a light-enhanced in-office tooth whitening system in order to assess tooth color and safety. METHODS: Thirty-three adults were randomly assigned to one of three treatment groups. Professional treatment involved application of a 25% H(2)O(2) gel (Discus Dental ZOOM!) with light enhancement, H(2)O(2) gel alone, or the light alone with no peroxide. The 12 anterior teeth were treated three times for 20 minutes each. Efficacy was measured objectively as L*a*b* color change using digital images, tooth shade was measured, and safety was evaluated immediately after treatment and at posttreatment days 7 and 30. RESULTS: After adjusting for baseline and age, immediate (end-of-treatment) means (SE) for Deltab* (yellowness) were -3.1 (0.25) for the gel + light, -2.0 (0.25) for the gel-only group, and -2.4 (0.25) for the light-only group. Significant (p < 0.05) color rebound was evident at posttreatment day 7. By day 30, adjusted means (SE)for Deltab* were -1.7 (0.20) for the gel + light group, -1.1 (0.20) for the gel-only group, and -0.5 (0.20) for the light-only group. Both peroxide groups differed significantly (p < 0.05) from light alone on Deltab* and DeltaL*. In the gel + light group, 91% of subjects experienced tooth sensitivity, the majority of which was moderate or severe. Adverse events were low in the light-only group. CONCLUSION: Use of light enhancement for in-office whitening leads to immediate color change, after which there was significant color and shade rebound within 7 days as well as moderate-to-severe tooth sensitivity during and after treatment. CLINICAL SIGNIFICANCE Increased tooth sensitivity during treatment and appreciable short-term color rebound after treatment may impact the utility of in-office tooth whitening with peroxide and light as a stand-alone esthetic procedure. (J Esthet Restor Dent 21:336-347, 2009).

Placebo-controlled clinical trial of use of 10% hydrogen peroxide whitening strips for medication-induced xerostomia.

OBJECTIVE: A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the effectiveness and safety of peroxide-containing strip-based tooth whitening among subjects with medication-induced hyposalivation. METHODS: Eligibility for this tooth whitening study was limited to dentate adults taking xerogenic medications with an unstimulated salivary flow < or = 0.2 ml/min. After giving informed consent, 42 subjects were randomized using a 2:1 ratio to 10% hydrogen peroxide whitening strips (Crest Whitestrips Premium) or placebo strips without peroxide. Strips were used for 30 min twice daily for a 14-day period. Usage was unsupervised, and only the maxillary arch was treated. On days 8 and 15, efficacy was assessed from standard digital images of the anterior dentition and quantified using the Cielab color system, while safety was assessed from interviews and clinical examinations. RESULTS: At day 8, the peroxide group experienced significant (p < 0.001) color improvement relative to baseline and placebo. Adjusted means +/- standard errors for yellowness reduction were -1.65 +/- 0.115 units for the peroxide group and -0.32 +/- 0.170 units for the placebo group. For the increase in lightness, adjusted means +/- standard errors on day 8 were 1.53 +/- 0.130 units for the peroxide group and 0.37 +/- 0.191 units for the controls. Continued strip use through day 15 yielded incremental color improvement for the peroxide group. Mild and transient tooth sensitivity represented the most common adverse events. No subject discontinued treatment due to a product-related adverse event. CONCLUSION: Twice daily use of 10% hydrogen peroxide whitening strips by adults with medication-induced xerostomia was well tolerated, with significant tooth color improvement evident within 7 days.

Effects of duration of whitening strip treatment on tooth color: a randomized, placebo-controlled clinical trial.

OBJECTIVES: A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate efficacy and safety of 6% hydrogen peroxide whitening strip used twice daily over an extended, 6-week period. METHODS: After informed consent, 40 eligible adults were randomly assigned to 6% hydrogen peroxide whitening strips (Crest Whitestrips, The Procter & Gamble Company, USA) or placebo strips without peroxide. Treatment was twice daily for 30min, and response was evaluated biweekly after initial (Week 2) and extended (Weeks 4 and 6) use. Tooth color was measured under standardized lighting conditions using digital image analysis, and safety was assessed from clinical examination and interview. Whitening was measured using data derived from digital images taken at baseline compared to post-treatment, with outcomes reported using the CIELAB color notation system. Analysis of variance and covariance were used to assess initial response, and repeated measures regression analysis was used to model color change during sustained use. RESULTS: Forty subjects (25-58 years old) started the study. At baseline, L* ranged from 68.0 to 76.8, a* ranged from 8.0 to 11.8, and b* ranged from 16.4 to 23.1. Groups differed significantly (p<0.001) on all color parameters at Week 2 and thereafter, favoring the 6% hydrogen peroxide strips. Week 2 adjusted means+/-SE were -2.1+/-0.2 for Deltab* and 1.9+/-0.2 for DeltaL* for the peroxide group compared to -0.3+/-0.2 for Deltab* and 0.4+/-0.2 for the placebo group. With sustained use (Weeks 2-6), the slope for the peroxide strip was estimated as -0.3 for Deltab* and +0.2 for DeltaL* per week, with both slopes differing significantly from zero (p<0.0001), while slopes for the placebo strip were not significant (p=0.22) and nearly zero. Treatment was generally well tolerated, with adverse events confined to symptoms only. CONCLUSIONS: Twice-daily use of 6% hydrogen peroxide whitening strips resulted in teeth becoming lighter and less yellow versus baseline and placebo during initial 2-week use, with no evidence of placebo response during sustained (Weeks 2-6) use.

A randomized clinical trial to compare plaque inhibition of a sodium fluoride/potassium nitrate dentifrice versus a stabilized stannous fluoride/sodium hexametaphosphate dentifrice.

AIM: To compare the plaque inhibition efficacy of a sodium fluoride/potassium nitrate (NaF/KNO3 with 1450 ppm F) test dentifrice to a 0.454% stannous fluoride/sodium hexametaphosphate/sodium fluoride positive control dentifrice (SnF2/SHMP with 1450 ppm F). METHODS AND MATERIALS: Twenty-five subjects were randomized to a two-period, two-treatment, double blind crossover sequence using NaF/KNO3 (Sensodyne ProNamel dentifrice) and SnF2/SHMP (blend-a-med* EXPERT GUMS PROTECTION dentifrice). Each treatment was conducted with a standard manual toothbrush (Oral-B P35 Indicator). Digital plaque image analysis (DPIA) was used on three consecutive days to evaluate: (a) overnight plaque formation (A.M. pre-brushing); (b) following 40 seconds of brushing with the test product (A.M. post-brushing); and (c) mid-afternoon (P.M.). Images were analysed using an objective computer algorithm to calculate the total area of visible plaque. A four-day washout period was instituted for the crossover phase. RESULTS: All 25 subjects completed the study. The SnF2/SHMP positive control dentifrice provided statistically significantly lower levels of plaque area coverage versus the NaF/KNO3 test dentifrice at each timepoint. For the SnF2/SHMP dentifrice, plaque coverage was 23.0% lower (p< 0.0001) at A.M. pre-brushing, 17.3% (p= 0.0163) lower at A.M. post-brushing, and 22.6% (p= 0.0004) lower at the P.M. measure relative to the NaF/KNO3 dentifrice. CONCLUSION: The SnF2/SHMP dentifrice (blend-a-med EXPERT GUMS PROTECTION) inhibits plaque regrowth both overnight and during the day to a significantly greater degree than the NaF/KNO3 dentifrice (Sensodyne ProNamel). CLINICAL SIGNIFICANCE: Dentists recommending an effective home use dentifrice for patients experiencing dentinal hypersensitivity and/or dental erosion may previously have needed to compromise on other key benefits, such as plaque control. blend-a-med EXPERT GUMS PROTECTION is a dentifrice when integrated into an oral hygiene routine can provide a proven treatment for hypersensitivity, dental erosion, and a reduction in the regrowth of plaque.