A Meta-analysis Comparing Toothbrush Technologies on Gingivitis and Plaque.

BACKGROUND: Research continues to show an association between oral health and systemic health, further stressing the importance of effective daily plaque removal via toothbrushing to maintain periodontal health and overall well-being. This investigation was undertaken to compare the efficacy of oscillating-rotating, sonic, and manual toothbrushes in reducing gingivitis and plaque in randomised controlled trials (RCTs) with up to 6 months' follow-up. METHODS: This meta-analysis was conducted from a single database (Procter & Gamble Oral Care Clinical Archive) including RCTs from 2007 to 2022. Three authors independently assessed study eligibility. Disagreements concerning selected studies were resolved by discussion with an expert colleague. Direct and indirect treatment comparisons along with transition rates to gingival health were calculated using participant-level data. Transition-to-health time was calculated using data from all time points. Subregion analyses evaluated number of bleeding sites and plaque reduction. RESULTS: This meta-analysis included 21 gingivitis RCTs and 25 plaque RCTs. Relative to manual and sonic brushes, oscillating-rotating brushes had a higher percentage of participants who transitioned to gingival health (72% vs 21% and 54%; P < .001). Compared with manual and sonic brushes, respectively, oscillating-rotating brushes demonstrated greater bleeding site reductions (by 52% and 29%; P < .001) and superior plaque reductions (by 19% and 5%; P < .001). Oscillating-rotating brushes provided faster transitions to health than sonic brushes and showed greater efficacy across subregions. The most advanced oscillating-rotating brush demonstrated statistically significantly greater efficacy compared with traditional oscillating-rotating, manual, and sonic brushes when analysed separately. Risk of bias was deemed low for all studies. CONCLUSIONS: Oscillating-rotating toothbrushes offer superior results for transition to health, gingivitis, and plaque reduction compared with manual and sonic brushes. The most advanced oscillating-rotating model offers enhanced efficacy vs traditional models.

A 4-week randomized controlled trial evaluating plaque and gingivitis effects of an electric toothbrush in a paediatric population.

BACKGROUND: Few extended studies have explored oscillating-rotating (O-R) toothbrush efficacy in young children. AIM: To compare the efficacy between O-R and manual toothbrushes in reducing plaque and gingivitis after 4 weeks in children. DESIGN: This was a randomized, parallel-group, examiner-blind, clinical trial. In two 50-subject cohorts (3-6 years, primary dentition, parental brushing; 7-10 years, mixed dentition, self-brushing), subjects used Oral-B Kids O-R toothbrush per manufacturer's instructions or Paro Junior manual toothbrush in a customary manner. Plaque and Modified Gingival Index (MGI; primary variable) scores were assessed at baseline and Week 4 for all subjects and within each age group. RESULTS: Both toothbrushes significantly reduced whole mouth and posterior plaque and MGI versus baseline (p < .001). Combined groups: O-R showed greater plaque and MGI reductions versus manual for all measures (p ≤ .003). Three- to 6-year-olds: O-R demonstrated significantly (p < .032) greater whole-mouth (55.7%) and posterior (34.3%) plaque reductions at Week 4 versus manual. Seven- to 10-year-olds: O-R showed significantly (p < .001) greater whole-mouth (94.5%) and posterior (108.4%) plaque reductions and greater (p ≤ .016) whole-mouth (14.1%) and posterior (18.8%) MGI reductions versus manual. There were no adverse events. CONCLUSION: The O-R toothbrush, used per manufacturer's instructions, reduced plaque and gingivitis better than a manual toothbrush used in a customary manner among children.

A randomized controlled trial assessing denture adhesive efficacy on denture retention across 13 hours.

PURPOSE: To compare the effects of two denture adhesive formulations on the bite force required to dislodge a maxillary denture in adult participants during a 13-h test period. MATERIALS AND METHODS: Twenty-two participants with a fair-to-poor fitting maxillary denture opposed by natural dentition or a stable mandibular denture were enrolled in this single-center, randomized, double-blind, two-treatment, 4-period crossover study. Participants were randomly assigned a product usage sequence so that each participant used each product twice during the 4-day test period. The test product was a denture cream adhesive formulated with an optimized calcium/zinc partial salt of polyvinyl methyl ether/maleic acid (Fixodent Ultra technology); the control product was a cream adhesive formulated with a calcium/zinc partial salt of polyvinyl methyl ether/maleic acid (Fixodent Original technology). On each study day, bite force at dislodgement was measured with a gnathodynamometer at baseline, representing the "no adhesive" score. Then, after standardized product application to the participant's existing maxillary denture by site staff, bite force measurements were retaken at 1, 3, 5, 7, 9, 11, and 13 h. The change from baseline and the 13-h area under the bite-force-change-from-baseline curve were analyzed via an analysis of variance. RESULTS: Twenty-one participants completed all test periods; one additional participant completed three test periods so 22 participants were included in the analysis. There were 15 females and 7 males with a mean age of 70 years. The mean 13-h area under the bite-force-change-from-baseline curve was 8% greater (p = 0.010) for the test adhesive (114.3 lb) than for the control adhesive (105.9 lb). Both adhesives showed a statistically significant increase in bite force (p < 0.001) at each time point compared to no adhesive. CONCLUSIONS: The optimized calcium/zinc partial salt of polyvinyl methyl ether/maleic acid test adhesive provided superior maxillary denture retention relative to that of the control adhesive across 13 h. Both adhesives increased bite force at dislodgement compared to no adhesive.

Brushing Behavior Changes and Plaque Removal with an Electric Toothbrush: A clinical trial.

Purpose To evaluate changes in toothbrushing behavior and plaque removal performance with usage of a next generation oscillating-rotating electric toothbrush (NG-OR).Methods This exploratory clinical study had a two-treatment, three-period, single-group, sequential design. Generally healthy adults with a screening whole mouth mean Turesky modified Quigley-Hein Plaque Index (TQHPI) score of at least 1.75 on a 0-5 scale and who were primarily OR brush users were enrolled. Participants used each OR toothbrush in A-B-B order, where a currently marketed OR brush with a traditional mechanical drive system (T-OR) was used in period A and the NG-OR brush with a linear magnetic drive was used in period B. At Visit 1, qualifying participants brushed on-site with T-OR. After a 48h washout, participants returned for Visit 2 and brushed on-site with NG-OR. Participants then used NG-OR for 1 week, twice daily, at home and returned for Visit 3 to brush on-site with NG-OR again. For all on-site brushings, participants were instructed to brush for 2min without interactive features. Each toothbrush was tagged with a transmitter chip connected to a Motion Tracking System to record movements of the toothbrush and participant using infrared light transmission to determine Isochronicity (brushing time uniformly distributed across the dentition). Plaque was measured using TQHPI. Primary variables were Isochronicity and TQHPl whole mouth mean plaque reduction (pre-brushing minus post brushing).Results Overall, 41 participants enrolled and received treatment; 40 completed the trial. NG-OR showed significantly greater Isochronicity after a single brushing (p=0.043) and after a 1-week at-home use (p=0.001) versus T-OR. NG-OR showed 41% greater whole mouth plaque removal than T-OR (p<0.001) after a single brushing. Plaque reduction by region/surface was consistent with whole mouth results.Conclusion The NG-OR brush showed greater brushing uniformity and plaque removal versus the T-OR brush.

Brushing behaviour changes and plaque removal with an electric toothbrush: A clinical trial.

OBJECTIVE: To evaluate changes in toothbrushing behaviour and plaque removal performance with usage of a next generation oscillating-rotating electric toothbrush (NG-OR). METHODS: This exploratory clinical study had a two-treatment, three-period, single-group, sequential design. Generally healthy adults with a screening whole mouth mean Turesky modified Quigley-Hein Plaque Index (TQHPI) score of at least 1.75 on a 0-5 scale and who were primarily OR brush users were enrolled. Participants used each OR toothbrush in A-B-B order, where a currently marketed OR brush with a traditional mechanical drive system (T-OR) was used in period A, and the NG-OR brush with a linear magnetic drive was used in period B. At Visit 1, qualifying participants brushed on-site with T-OR. After a 48 h washout, participants returned for Visit 2 and brushed on-site with NG-OR. Participants then used NG-OR for 1 week, twice daily, at home and returned for Visit 3 to brush on-site with NG-OR again. For all on-site brushings, participants were instructed to brush for 2 min without interactive features. Each toothbrush was tagged with a transmitter chip connected to a Motion Tracking System to record movements of the toothbrush and participant using infrared light transmission to determine Isochronicity (brushing time uniformly distributed across the dentition). Plaque was measured using TQHPI. Primary variables were Isochronicity and TQHPl whole mouth mean plaque reduction (pre-brushing minus post-brushing). RESULTS: Overall, 41 participants enrolled and received treatment; 40 completed the trial. NG-OR showed significantly greater Isochronicity after a single brushing (p = 0.043) and after a 1-week at-home use (p = 0.001) versus T-OR. NG-OR showed 41% greater whole mouth plaque removal than T-OR (p < 0.001) after a single brushing. Plaque reduction by region/surface was consistent with whole mouth results. CONCLUSION: The NG-OR brush showed greater brushing uniformity and plaque removal versus the T-OR brush.

Tooth color change and tolerability evaluation of a hydrogen peroxide whitening strip compared to a strip, paste, and rinse regimen containing plant-based oils and Dead Sea salt.

PURPOSE: To assess tooth color changes and tolerability with use of a hydrogen peroxide whitening strip compared to a regimen of a strip, rinse and paste for tooth whitening. METHODS: This was a single-center, parallel-group, double-blind, randomized controlled clinical trial. Qualified generally healthy adult participants were assigned to one of two treatment groups. The test group included peroxide-free strips, a fluoride-free whitening toothpaste, and a whitening mouthwash (all Lumineux Oral Essentials); all test products contain plant-based oils (coconut, sage, and lemon peel) and Dead Sea salt. The control group included hydrogen peroxide whitening strips (Crest 3DWhitestrips Classic White) and a sodium fluoride non-whitening toothpaste (Crest). Both groups used a soft manual toothbrush (Oral-B). Strips (for both groups) and rinse (for test group) were used once daily. Changes in tooth color were assessed objectively and quantitatively by digital image analysis after 7, 10 and 14 treatments. RESULTS: 50 participants were enrolled and randomized to treatment and 48 completed the trial. Participants had an average age of 40.8 years (range 18 to 62 years) and 64% were female. At the end of treatment, the test group did not provide statistically significant changes in yellowness (b*) or lightness (L*) from baseline (P≥ 0.411), whereas the control group demonstrated a statistically significant mean yellowness reduction (SD) of 1.55 (0.703) and a mean lightness improvement (SD) of 1.57 (1.141) compared to baseline (P< 0.001 for both). The control group also provided statistically significantly greater mean yellowness reductions and mean lightness improvements compared to the test group at all time points (P< 0.002). Products in both groups were well tolerated, with minor oral irritation and tooth sensitivity representing the most common findings during treatment. CLINICAL SIGNIFICANCE: The Crest Whitestrips control whitening strip provided significant tooth whitening efficacy, whereas the Lumineux Oral Essentials test regimen containing plant-based oils and Dead Sea salt did not. This evidence is important for dental professionals to consider when making recommendations for patients seeking at-home whitening treatments.

Evaluation of an advanced oral hygiene regimen on maternity outcomes in a randomized multicenter clinical trial (Oral Hygiene and Maternity Outcomes Multicenter Study).

BACKGROUND: During pregnancy, dental plaque-induced gingivitis prevalence and subsequent risk of periodontal disease increases substantially, as a consequence of both inadequate oral hygiene and changes in sex steroid hormone levels. Although maternal periodontal disease has been associated with adverse pregnancy outcomes, including spontaneous preterm birth, previous clinical trials involving mechanical debridement (eg, scaling and root planing) to remove plaque biofilm have not yielded decreased rates of preterm birth. OBJECTIVE: We hypothesized that an advanced oral hygiene program, including an antibacterial regimen coupled with a power toothbrush and hygiene instruction, may improve the periodontal milieu and reduce the rate of spontaneous preterm birth. Therefore, we conducted a clinical trial of obstetrical patients with moderate-to-severe gingivitis who were randomized to an advanced oral hygiene program vs usual oral hygiene care, and the primary obstetrical outcome compared between the treatment groups was gestational age at delivery. STUDY DESIGN: Obstetrical patients with singleton pregnancies between 8 and 24 weeks' gestation were screened by trained dentists at 2 clinical sites for moderate-to-severe gingivitis (>30 intraoral sites with gingival bleeding on probing). Eligible participants were randomized to an advanced oral hygiene regimen, including antibacterial mouth wash, dental floss, antibacterial toothpaste, a power toothbrush, and intensive oral hygiene education vs standard oral home care instructions and regimen. The primary obstetrical outcome assessed was gestational age at delivery. The overall primary (dental) outcomes were gingival index, bleeding sites, and pocket depth (reported elsewhere). Secondary obstetrical outcomes included birthweight and incidence of preterm birth at <37 weeks' gestation. Regression models were utilized and included factors such as treatment group, gestational age at enrollment, preterm birth history, and potential markers of health disparities (ie, education, employment status). RESULTS: A total of 817 obstetrical patients underwent dental screening at the 2 sites, 789 were identified with moderate-to-severe gingivitis, 746 were randomized, and birth outcomes were available for 613 of the study participants. The gestational age at delivery was 2 days earlier in the control group (P=.040), but the clinical significance of this finding was limited (39.13 vs 38.85 weeks). Overall rates of spontaneous preterm birth <37 weeks and <34 weeks were not statistically different between the 2 treatment groups (7.0% advanced oral hygiene regimen vs 10.3% controls, OR=1.63 (0.90-3.00), P=.11; and 2.3% vs 3.9%, OR=1.88 (0.71-4.98), P=.20, respectively). However, we observed lower rates of spontaneous preterm birth among unemployed participants with less favorable socioeconomic status (4.7% advanced oral hygiene regimen vs 16.0% controls, OR=4.04 (1.34-15.12), P=.01). CONCLUSION: An advanced oral hygiene program may reduce the risk of spontaneous preterm birth among pregnant patients with moderate-to-severe gingivitis and health disparities. This is the same group that may be at highest risk of poor dental hygiene and preterm birth.

A Randomized Controlled Clinical Trial of Prenatal Oral Hygiene Education in Pregnancy-Associated Gingivitis.

INTRODUCTION: Research shows there is a significant increase in gingival inflammation during pregnancy. This study was conducted to determine if an oral health intervention (OHI), including oral hygiene education delivered by nurse-led staff and an advanced over-the-counter (OTC) oral home care regimen, improved gingival inflammation in pregnant women with moderate-to-severe gingivitis compared with a standard oral hygiene control group. METHODS: This was a multicenter, randomized, controlled, single-masked, parallel group clinical trial conducted in obstetrics clinics of 2 medical centers. A total of 750 pregnant women between 8 and 24 weeks of pregnancy with at least 20 natural teeth and moderate-to-severe gingivitis (>30 intraoral bleeding sites) were enrolled. Participants were randomized to either the OHI group, which included oral hygiene instructions supplemented with an educational video and advanced OTC antibacterial/mechanical oral hygiene products, or the control group receiving oral hygiene instructions and standard products. Both groups received oral hygiene instructions from nurse-led staff. Experienced, masked examiners measured whole mouth gingival index (GI) and periodontal probing depths (PDs) at baseline and months 1, 2, and 3. RESULTS: Participants enrolled in this study presented with moderate-to-severe gingivitis at baseline. Both the OHI and control groups exhibited significant reductions in GI (P < .001) and PD (P < .03) from baseline that persisted throughout the study period. The OHI group exhibited modest, yet statistically greater, reductions in GI (P ≤ .044) compared with the control at all time points. The reduction in PD directionally favored the OHI group, but between-group differences were small (<0.03 mm) and not statistically significant (P > .18). DISCUSSION: Significant gingivitis was prevalent among participants in this study and identifies an opportunity to improve gingival health during pregnancy by providing oral health education during the course of prenatal care when coupled with an advanced OTC oral hygiene regimen.

Gingival health effects with an oscillating-rotating electric toothbrush with micro-vibrations and a novel brush head designed for stain control: Results from a 12-week randomized controlled trial.

PURPOSE: To evaluate the reduction of plaque and gingivitis by an oscillating-rotating (O-R) smart-connected electric rechargeable toothbrush with micro-vibrations used with a novel brush head designed for stain control versus a manual toothbrush. METHODS: 100 adult subjects with evidence of gingivitis and plaque were enrolled in this single-center, examiner-blind, two-treatment, parallel-group, controlled trial. Subjects were randomized to either the O-R toothbrush used in whitening mode (Oral-B iO with Radiant White brush head) or the manual toothbrush (Oral-B Indicator). Subjects brushed twice daily with their assigned toothbrush and a standard sodium fluoride dentifrice. At baseline, week 1, and week 12, gingivitis was assessed with the Modified Gingival Index (MGI) and the Gingival Bleeding Index (GBI), and plaque was assessed with the Rustogi Modification of the Navy Plaque Index (RMNPI). Gingival case status was classified as " healthy" (< 10% bleeding sites) or "not healthy" (≤ 10% bleeding sites) according to the standard of the American Academy of Periodontology and the European Federation of Periodontology. RESULTS: All 100 subjects who were randomized to treatment completed the study. At baseline, the gingival case status for all subjects was classified as "not healthy". By week 12, 86% of subjects in the O-R brush group had transitioned to a " healthy" case status, in contrast to 20% of subjects in the manual toothbrush group (P< 0.001). The reduction in the adjusted mean number of bleeding sites from baseline was greater for the O-R brush group than for the manual brush group [at week 12, by 24.5 (74.6%) vs. by 7.8 (23.7%), respectively; P< 0.001]. Reductions for adjusted mean MGI and GBI scores were likewise statistically significantly greater for the O-R brush group relative to those of the manual brush group (P< 0.001). The O-R brush also provided greater relative reductions in adjusted mean whole mouth, gingival margin and approximal RMNPI scores at week 12 (P< 0.001), and plaque was similarly reduced in the lingual and buccal subregions (P< 0.001). Significant between-group plaque reductions favoring the O-R brush were observed for all regions as early as first use (P< 0.001). CLINICAL SIGNIFICANCE: The results of this 12-week study support the recommendation of the O-R toothbrush with micro-vibrations, used in whitening mode with a novel brush head designed for stain control, so patients motivated by esthetic desires can personalize their brushing experience without compromising cleaning and gingival health efficacy.

A 12-Week Randomized Controlled Trial Comparing a Novel Electric Toothbrush With an Extra Gentle Brush Head to a Manual Toothbrush for Plaque and Gingivitis Reduction.

OBJECTIVE: This study compared the gingivitis and plaque reduction efficacy of a novel smart-connected oscillating-rotating (O-R) electric toothbrush with micro-vibrations, used in Sensitive mode with an extra gentle ("sensitive") brush head, to the efficacy of a soft manual toothbrush. METHODS: This was a 12-week, examiner-blind, two-treatment, parallel-group clinical trial with 100 adult subjects (N = 100) having evidence of gingivitis and plaque at baseline. Subjects were randomly assigned to use either the O-R electric rechargeable toothbrush (Oral-B iO with Oral-B Gentle Care brush head) or the soft manual toothbrush (Oral-B Indicator). Gingivitis was assessed with the modified gingival index (MGI) and the gingival bleeding index (GBI). Plaque was assessed with the Rustogi modification of the navy plaque index (RMNPI). Patients were classified as having a "healthy" or "not healthy" gingival case status according to the criteria of the American Academy of Periodontology and the European Federation of Periodontology. Efficacy assessments and oral soft-tissue examinations were conducted before brushing at baseline, week 1, and week 12. The baseline assessment included both pre- and post-brushing plaque evaluations to evaluate single-use plaque removal efficacy. RESULTS: All 100 subjects completed the trial. Subjects had a mean age of 49.1 years; 72% were females. The O-R brush group had a significantly higher percentage of subjects who transitioned from "not healthy" to "healthy" gingival case status than did the manual brush group. Plaque reduction for the O-R brush group was also significantly greater (P ≤ .009) than for the manual brush group for whole mouth, gingival margin, and interproximal region, from day 1 (single use) through 12 weeks. Both brushes were well tolerated. CONCLUSION: The novel O-R toothbrush with micro-vibrations used in Sensitive mode with an extra gentle brush head provided significantly greater gingivitis and plaque reduction than did a manual toothbrush over 12 weeks.

Application of non-inferiority testing in microhardness and its relationship to erosion: Relevance for hard tissue safety evaluations.

PURPOSE: To use non-inferiority statistical testing with simple microhardness measurements (SMH) as a prediction of potential erosive hard tissue damage of topical treatments on enamel. METHODS: Three independent experiments of a simple acid cycling demineralization (ACD) model were used to screen softening effects of various commercial beverages on dental enamel. The cycling model consists of six repeated exposures of enamel slabs with alternating treatments of artificial saliva over the course of 6 hours. After six repeated cycles, effects on surface microhardness were measured. Softening effects of beverages were evaluated using a statistical non-inferiority test of the positive control (water) and negative control (1% citric acid). To confirm whether softening effects as evaluated by a non-inferiority test translated to like differences in enamel erosion susceptibility, selected beverages then underwent more complex erosion cycling model (ECM) evaluation where enamel blocks were cycled with beverages (vs. historically established citric acid) and pooled saliva over a period of 5 days. The ECM also incorporated dentifrice treatments, sodium fluoride (NaF, Crest Cavity Protection, negative control) and a positive control stannous fluoride dentifrice (SnF2, Crest Pro-Health Advanced), to confirm model performance against historically published results of in situ erosion protection benefits of SnF2. RESULTS: There was a spectrum of softening properties of 16 commercial beverages in the ACD test, ranging from a ΔSMH of -22.6 to -316 vs. baseline. Four beverages were evaluated further in ECM testing. Despite a measurable change in SMH, Sprite and beer treatments in the ACD passed the statistical non-inferiority test and both were evaluated in erosion cycling, showing no enamel surface loss. Vinegar (~5% acetic acid) and Gatorade also showed measurable changes in SMH in the ACD, but they failed statistical non-inferiority testing. Both beverages subsequently showed significant enamel tissue loss (erosion) in further erosion cycling testing. This combined set of data suggests that simple surface microhardness evaluation may be used as a proxy for potential erosion surface loss if properly quantified. SnF2 dentifrice significantly reduced erosion from all erosive beverages with greater efficacy than NaF control dentifrice, consistent with prior clinical and in vitro evidence. CLINICAL SIGNIFICANCE: The ACD model with application of non-inferiority statistical testing is proposed as a simple model of hard tissue safety assessment of treatments, including oral hygiene products. Products that pass the non-inferiority test in ACD (surface softening) are proposed as safe for enamel as there is no suggestion from this data that teeth are at risk of tissue loss due to these products. On the other hand, products failing the non-inferiority test require confirmatory safety qualification in erosion cycling. Products equal or worse than citric acid with ACD or with significant erosion in ECM are suggested to warrant reformulation unless favorable safety data for enamel (lack of erosion) or the appropriate justification are provided.

Anti-gingivitis and Anti-plaque Efficacy of an Oral Hygiene System: Results From a 12-Week Randomized Controlled Trial.

The objective of this study was to compare the antigingivitis and antiplaque efficacy of an oral hygiene system versus a control regimen. This was a single-center, randomized, examiner-blind, two-treatment, 12-week parallel group study in adults with evidence of gingivitis and plaque. Eligible subjects were stratified by baseline gingivitis and plaque scores, number of bleeding sites, and tobacco use and randomized to one of two treatment groups: (1) oral hygiene system (test group) involving a novel smart-connected Oral-B® iO oscillating-rotating (O-R) electric toothbrush, 0.454 percent stabilized stannous fluoride (SnF2) dentifrice, 0.07 percent cetylpyridinium chloride (CPC) rinse, and floss, or (2) control regimen involving a manual toothbrush and 0.243 percent sodium fluoride dentifrice. Gingivitis (modified gingival index, gingival bleeding index) and plaque (Rustogi modification of the navy plaque index) were assessed at Baseline, Week 1, and Week 12.

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.

Randomized clinical trial assessing anti-gingivitis efficacy of two stannous fluoride dentifrices and zinc/arginine dentifrice.

PURPOSE: To evaluate the anti-gingivitis efficacy of two bioavailable stannous fluoride (SnF2) dentifrices versus a zinc/arginine dentifrice and a negative control dentifrice, and to compare the plaque control benefits. METHODS: This was a single-center, randomized, controlled, four-treatment, parallel-group, double-blind, 3-month clinical trial. Healthy adult subjects with gingivitis were randomly assigned to one of four different dentifrice treatment groups: SnF2 dentifrice A, SnF2 (1,100 ppm F) + sodium fluoride (350 ppm F) + sodium hexametaphosphate (Procter & Gamble); SnF2 dentifrice B, SnF2 (1,100 ppm F) + sodium fluoride (350 ppm F) + citrate (Procter & Gamble); Zn/Arg dentifrice, zinc/arginine + sodium fluoride (1,450 ppm F) (Colgate-Palmolive); negative control dentifrice, sodium monofluoro-phosphate (1,000 ppm F) + sodium fluoride (450 ppm F) (Colgate-Palmolive). Subjects brushed with their assigned treatment dentifrice and an assigned manual toothbrush (Oral-B Indicator) for 1 minute, twice daily, for the duration of the study. Gingivitis was assessed at Baseline and at Weeks 2, 4 and 12 by calculating the total number of gingival bleeding sites using the Gingival Bleeding Index, and plaque was assessed at Baseline and at Week 12 using the Turesky Modified Quigley-Hein Index. A repeated measures model was carried out across Weeks 2, 4, and 12 to determine bleeding efficacy (total number of bleeding sites). An ANCOVA with baseline plaque as the covariate was used to evaluate plaque efficacy at Week 12. RESULTS: 161 subjects were randomized (mean age= 38.8 years). 154 subjects completed the study and 153 had evaluable data at Week 12. The mean (SD) number of Baseline bleeding sites overall was 78.74 (31.16) with no significant difference between groups (P= 0.537). SnF2 dentifrice A significantly reduced the number of bleeding sites relative to the negative control dentifrice at Weeks 2, 4 and 12 by 15.4%, 13.7% and 17.2%, respectively. SnF2 dentifrice B significantly reduced the number of bleeding sites relative to the negative control dentifrice at Week 4 by 13.9% (P= 0.041). Relative to the Zn/Arg dentifrice, SnF2 dentifrice A produced significantly greater reductions in gingival bleeding sites at Weeks 2, 4 and 12 by 23.4%, 17.2% and 20.9%, respectively (P≤ 0.007). SnF2 dentifrice B produced significantly greater bleeding reductions versus the Zn/Arg dentifrice at Weeks 4 and 12 by 17.4% and 14.4%, respectively (P≤ 0.035). The Zn/Arg dentifrice did not differ significantly in the number of bleeding sites (P≥ 0.127) or plaque (P= 0.175) relative to the negative control dentifrice. Both SnF2 dentifrices significantly reduced plaque levels (P≤ 0.029) relative to both negative control dentifrice and Zn/Arg dentifrice at Week 12. All dentifrices were well tolerated. CLINICAL SIGNIFICANCE: Two different SnF2 dentifrices showed significantly reduced gingival bleeding and plaque levels relative to a Zn/arginine dentifrice.

Investigation of oral malodor prevention by dentifrices as measured by VSC reduction.

The oral malodor reduction efficacy of dentifrices containing stannous fluoride (SnF2) or zinc plus arginine (Zn/Arg) was evaluated using a halimeter to measure volatile sulfur compounds (VSCs) in two randomized, controlled, single-blind, cross-over pilot clinical trials. Study 1 (N= 16) had five 1100 ppm F dentifrices and five treatment periods: negative control (NC): 0.243% sodium fluoride (NaF); SnF2A: 0.454% SnF2+ pyrophosphate; SnF2B: 0.454% SnF2+ sodium hexametaphosphate; SnF2C: 0.454% SnF2+ citrate; and SnF2D: experimental 0.454% SnF2with increased bioavailable Sn. Study 2 (N= 16) had four 1450 ppm F dentifrices and four treatment periods: NC: 0.1% NaF + 0.76% sodium monofluorophosphate; Zn/Arg: NaF + zinc + arginine; SnF2E: 0.454% SnF2+ 0.078% NaF + sodium hexametaphosphate; SnF2F: 0.454% SnF2+ 0.078% NaF + citrate. Each period took 96 h; baseline (day 0) morning to day 4 morning. Subjects brushed 2x/day with the treatment dentifrice. VSC levels were measured in the morning, prior to morning brushing, on days 0 and 4. Changes in VSC scores from day 0 to day 4 were assessed using a mixed-model analysis of covariance for cross-over studies. In study 1, SnF2dentifrices B, C and D showed statistically significant reductions (31.3%, 24.8%, 34%, respectively) in VSC scores versus baseline (p< 0.001); the benefits of these treatments versus NC and SnF2dentifrice A were statistically significant (p⩽ 0.001). In study 2, SnF2dentifrices E and F showed statistically significant reductions (31.2%, 22.1%, respectively) in VSC scores versus baseline (p⩽ 0.010); the benefits of these treatments versus NC and the Zn/Arg dentifrice were statistically significant (p⩽ 0.035). The Zn/Arg dentifrice showed a significant increase of 35.2% (p< 0.001) in VSC scores versus baseline. These studies demonstrated that SnF2dentifrices can provide significant oral malodor reductions, but the benefit is formulation dependent. The presence of SnF2is not sufficient to ensure efficacy. The Zn/Arg dentifrice increased VSC levels, indicating greater malodor.Clinical Trial Numbers: 20190429 and 20191028.

A 6-month randomized controlled trial evaluating a novel smart-connected oscillating-rotating toothbrush versus a smart-connected sonic toothbrush for the reduction of plaque and gingivitis.

PURPOSE: This 6-month study compared the effects of a smart-connected oscillating-rotating (O-R) electric rechargeable toothbrush with micro-vibrations with those of a marketed smart-connected sonic rechargeable toothbrush for the reduction of gingivitis and plaque. METHODS: In this single-center, examiner-blind, two-treatment, open-label, parallel-group, randomized study, 110 adult subjects with evidence of gingivitis and plaque were randomized to use either the O-R brush (Oral-B iO) or the sonic brush (Philips Sonicare DiamondClean). Both groups were instructed to brush twice daily with a standard sodium fluoride dentifrice. Gingivitis and plaque were assessed at baseline, week 1, and week 24 using the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and the Rustogi Modification of the Navy Plaque Index (RMNPI). Designation of gingivitis case status as "healthy" or " not healthy" was made according to the World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. RESULTS: A significantly greater percentage of subjects in the O-R brush group versus the sonic brush group transitioned from " not healthy" to " healthy" gingivitis case status at week 24 (96.4% vs. 81.8%; P= 0.029). The O-R toothbrush produced a significantly greater reduction in adjusted mean MGI score, adjusted mean GBI score, and adjusted mean number of bleeding sites than did the sonic brush (week 24, by 32.6% for MGI score, by 23.7% for GBI score, and by 26.1% for number of bleeding sites, P< 0.001). After a single use on day 1, plaque removal was statistically significantly greater for the O-R brush compared to the sonic brush (P< 0.001); by week 24, the O-R brush demonstrated greater reductions in whole mouth plaque (24.6%), gingival margin plaque (61.9%) and approximal region plaque 25.8% (P≤ 0.007 for all) compared to the sonic brush. CLINICAL SIGNIFICANCE: This 6-month study provides evidence supporting use of a smart-connected O-R electric toothbrush with micro-vibrations for plaque removal and gingivitis reductions, resulting in transitions to a healthy gingival state.

Randomised clinical study of plaque removal efficacy of an electric toothbrush in primary and mixed dentition.

BACKGROUND: Clinical investigations of electric toothbrushes in young children are limited. AIM: To assess plaque reduction efficacy of an oscillating-rotating electric versus manual toothbrush in a paediatric population in primary and mixed dentitions. DESIGN: In this randomised, single-brushing, 2-treatment, 4-period, replicate-use crossover study, subjects were divided into 2 age groups (3-6 years; 7-9 years) and assigned to a treatment sequence involving an Oral-B Kids electric brush and a manual brush control. Plaque was assessed pre- and post-brushing (Turesky Modified Quigley-Hein Plaque Index). Parents brushed the teeth of their children aged 3-6 years, whereas children aged 7-9 years brushed their own teeth under supervision. Plaque removal scores were analysed for brush differences in each age group separately using an analysis of covariance for crossover design. RESULTS: Forty-one children (n = 20, 3-6 years; n = 21, 7-9 years) completed the study. For the primary dentition in children 3-6 years, the electric brush reduced 32.3% more plaque than the manual brush (P = .005). For the mixed dentition in children 7-9 years, the electric brush reduced 51.9% more plaque than the manual brush (P < .001). CONCLUSIONS: An electric toothbrush reduced significantly more plaque than a manual toothbrush in 2 paediatric age groups.

Factors Associated with Dental Plaque, Gingivitis, and Caries in a Pediatric Population: A Records-Based Cross-Sectional Study.

This retrospective, cross-sectional study evaluated dental records of 1000 healthy children to determine factors associated with plaque, gingivitis, and caries. A logistic model for plaque and gingivitis (mild versus moderate/severe) and caries (yes/no) was carried out separately for each variable using the following potential factors: Age, Gender, Brush Type, Starting Age of Brushing, Brushing Frequency, and Bite Type. Data from 998 children (median age: 4 years, 10 months (range: 2.5-7 years)) were analyzed. Sixty-four percent were manual toothbrush users; 36% were oscillating-rotating electric toothbrush users. For plaque and gingivitis, but not caries, Brush Type was more impactful than Brushing Frequency. Age influenced the severity of plaque and gingivitis, with increases in the odds of having moderate/severe plaque or gingivitis associated with increasing age. The probability of caries increased until approximately age 5 and then decreased until age 7. Oscillating-rotating brush users were more likely to present with less plaque, gingivitis, and caries, with 6.0, 5.1, and 1.4 times greater odds of having mild (versus moderate/severe) plaque, less severe gingivitis, and being caries-free, respectively, than manual brush users. Similarly, brushing twice daily and starting brushing at an earlier age were associated with better oral health outcomes. Children with anterior bite abnormalities had increased odds of developing moderate/severe plaque and gingivitis than children with normal anterior bites. Gender was not a statistically significant factor associated with plaque, gingivitis, or caries. Children's oral health is influenced by toothbrush type, starting age of brushing, compliance with twice-daily brushing, and bite abnormalities.

The relative clinical efficacy of three 0.454% stannous fluoride dentifrices for the treatment of gingivitis over 3 months.

PURPOSE: To assess the safety and efficacy of three stannous fluoride (SnF2) dentifrices in the reduction of gingivitis versus a negative control dentifrice. METHODS: This was a randomized, controlled, double-blind, four-treatment parallel group study. 120 healthy adult volunteers with established gingivitis were enrolled and randomly assigned to one of four dentifrice treatment groups (30/group): 0.454% SnF2 + citrate dentifrice A; 0.454% SnF2 + sodium hexametaphosphate dentifrice B; 0.454% SnF2 + pyrophosphate dentifrice C; or 0.76% sodium monofluorophosphate negative control group. Subjects brushed with their assigned dentifrice and an assigned regular manual toothbrush (Oral-B Indicator) for 1 minute twice daily for 12 weeks. Number of gingival bleeding sites and Löe-Silness Gingival Index (LSGI) scores were assessed at baseline and at Weeks 2, 4 and 12. RESULTS: 120 subjects were enrolled and 112 completed the trial. Subjects had an average age (SD) of 39.31 (14.5) years; 67% of subjects were female. Overall baseline means (SD) were 81.2 (25.6) for number of bleeding sites and 1.51 (0.197) for mean LSGI score. Baseline disease levels were balanced across all treatment groups. At Week 2, SnF2 dentifrices A and B demonstrated a significant reduction in gingival bleeding sites versus the negative control; however, SnF2 dentifrice C was not significantly different from the negative control (P= 0.15). At Weeks 4 and 12, all SnF2 dentifrices demonstrated a significant gingival bleeding site reduction versus the negative control (P< 0.001). At Weeks 2, 4 and 12, the SnF2 dentifrices were rank ordered dentifrice A > dentifrice B > dentifrice C for reduction in gingival bleeding sites (P< 0.001). The same trends were seen for LSGI scores. CLINICAL SIGNIFICANCE: In this 12-week clinical study, all 0.454% SnF2 dentifrices delivered statistically significant reductions in the number of gingival bleeding sites relative to the negative control. Importantly, statistically significant efficacy differences were observed among the three 0.454% SnF2 dentifrices, demonstrating the important role that differences in formulation have on clinical efficacy.

Laboratory screening evaluation of the safety of low pH oral care rinse products to dental enamel.

PURPOSE: To assess the hard tissue safety of a variety of low pH oral care rinses to dental enamel in a newly developed screening method. METHODS: Bovine enamel specimens were subjected to a cycling model that consisted of commercial mouthrinse product exposures and artificial saliva soaks based on a previously published screening method. The effect of test products on the surface of treated specimens was measured using surface microhardness (SMH). Results are presented as the change in SMH (between sound enamel baseline and cycling final). An assortment of rinse products were assessed relative to distilled water (positive control) and 1% citric acid (negative control). A priori, a product was considered safe if the change in measured SMH values over the course of six treatment cycles was both significantly greater than the negative control and was not significantly different from the positive control. A non-inferiority statistical test was applied to create a quantitative rule defining product safety. RESULTS: Products tested included two rinses with a pH in excess of 5.5, and eight with a pH less than 5.5. Four of the rinses included fluoride, while six did not. Analyses showed that all of the rinse products tested passed the non-inferiority acceptance criteria. One of the 10 marketed oral care rinses failed to meet the a priori criteria needed to be considered safe as the product was significantly better than the negative control but also significantly lower than the positive control treatment. This product had the lowest pH of all products tested and did not contain fluoride. Application of the non-inferiority statistical test showed the questionable product passing safety criteria. As a proposed method for a screening tool, further testing would be recommended based on these results. CLINICAL SIGNIFICANCE: An in vitro enamel safety screening method was applied as an assessment of the enamel demineralization safety to a number of oral care rinse products. Surface microhardness, coupled with a non-inferiority statistical evaluation, provided a reasonable approach for detecting potential product issues. Products failing this screening laboratory method may require additional testing to verify their safety on hard tissues.