A proof of principle investigation of a novel enzyme formulation on dental calculus deposition: a 4-week randomized human clinical trial.

BACKGROUND: The dissolution of dental calculus, safely and at home, is among the more challenging issues facing the over-the-counter healthcare industry. Pontis Biologics, Inc. has developed novel model of calculus development and structure and has formulated a dentifrice (Tartarase™) using digestive enzymes as active ingredients that is shown to dissolve dental calculus in this Proof of Principle clinical trial. METHODS: This investigation was designed to evaluate the safety and efficacy of a novel enzyme formulation to remove existing calculus deposits in 4 weeks, measured using the Volpe-Manhold Index (V-MI) on lingual surfaces of 6 lower anterior teeth. The test formulation was compared to Crest Cavity Protection, as a control dentifrice. A total of 40 randomized test subjects began the study with 20 assigned to the control dentifrice and 20 assigned to the Tartarase groups (ten each, one brushing with Tartarase twice daily and one brushed with Tartarase and wore a dental tray filled with Tartarase for 30 min then brushed again with Tartarase, once daily). RESULTS: The Crest group experienced a 12% increase in calculus, in contrast to the results of both Tartarase groups that experienced a 40% reduction in calculus in 4 weeks of unsupervised at home use of the Tartarase toothpaste formulation. CONCLUSIONS: This proof of principle study demonstrates that a dentifrice, formulated along the lines of the Tartarase material, is capable of combating calculus accumulation using the same oral hygiene habits that are common worldwide. TRIAL REGISTRATION: This trial was registered retrospectively at clinicaltrials.gov and has the Unique Identification Number: NCT06139835, 14/11/2023.

Quantitative analysis of the effects of brushing, flossing, and mouthrinsing on supragingival and subgingival plaque microbiota: 12-week clinical trial.

BACKGROUND: Translational microbiome research using next-generation DNA sequencing is challenging due to the semi-qualitative nature of relative abundance data. A novel method for quantitative analysis was applied in this 12-week clinical trial to understand the mechanical vs. chemotherapeutic actions of brushing, flossing, and mouthrinsing against the supragingival dental plaque microbiome. Enumeration of viable bacteria using vPCR was also applied on supragingival plaque for validation and on subgingival plaque to evaluate interventional effects below the gingival margin. METHODS: Subjects with gingivitis were enrolled in a single center, examiner-blind, virtually supervised, parallel group controlled clinical trial. Subjects with gingivitis were randomized into brushing only (B); brushing and flossing (BF); brushing and rinsing with Listerine® Cool Mint® Antiseptic (BA); brushing and rinsing with Listerine® Cool Mint® Zero (BZ); or brushing, flossing, and rinsing with Listerine® Cool Mint® Zero (BFZ). All subjects brushed twice daily for 1 min with a sodium monofluorophosphate toothpaste and a soft-bristled toothbrush. Subjects who flossed used unflavored waxed dental floss once daily. Subjects assigned to mouthrinses rinsed twice daily. Plaque specimens were collected at the baseline visit and after 4 and 12 weeks of intervention. Bacterial cell number quantification was achieved by adding reference amounts of DNA controls to plaque samples prior to DNA extraction, followed by shallow shotgun metagenome sequencing. RESULTS: 286 subjects completed the trial. The metagenomic data for supragingival plaque showed significant reductions in Shannon-Weaver diversity, species richness, and total and categorical bacterial abundances (commensal, gingivitis, and malodor) after 4 and 12 weeks for the BA, BZ, and BFZ groups compared to the B group, while no significant differences were observed between the B and BF groups. Supragingival plaque vPCR further validated these results, and subgingival plaque vPCR demonstrated significant efficacy for the BFZ intervention only. CONCLUSIONS: This publication reports on a successful application of a quantitative method of microbiome analysis in a clinical trial demonstrating the sustained and superior efficacy of essential oil mouthrinses at controlling dental plaque compared to mechanical methods. The quantitative microbiological data in this trial also reinforce the safety and mechanism of action of EO mouthrinses against plaque microbial ecology and highlights the importance of elevating EO mouthrinsing as an integral part of an oral hygiene regimen. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov on 31/10/2022. The registration number is NCT05600231.

Quantitative analysis of the effects of essential oil mouthrinses on clinical plaque microbiome: a parallel-group, randomized trial.

BACKGROUND: The rich diversity of microorganisms in the oral cavity plays an important role in the maintenance of oral health and development of detrimental oral health conditions. Beyond commonly used qualitative microbiome metrics, such as relative proportions or diversity, both the species-level identification and quantification of bacteria are key to understanding clinical disease associations. This study reports the first-time application of an absolute quantitative microbiome analysis using spiked DNA standards and shotgun metagenome sequencing to assess the efficacy and safety of product intervention on dental plaque microbiome. METHODS: In this parallel-group, randomized clinical trial, essential oil mouthrinses, including LISTERINE® Cool Mint Antiseptic (LCM), an alcohol-containing prototype mouthrinse (ACPM), and an alcohol-free prototype mouthrinse (AFPM), were compared against a hydroalcohol control rinse on clinical parameters and the oral microbiome of subjects with moderate gingivitis. To enable a sensitive and clinically meaningful measure of bacterial abundances, species were categorized according to their associations with oral conditions based on published literature and quantified using known amounts of spiked DNA standards. RESULTS: Multivariate analysis showed that both LCM and ACPM shifted the dysbiotic microbiome composition of subjects with gingivitis to a healthier state after 4 weeks of twice-daily use, resembling the composition of subjects with clinically healthy oral conditions recruited for observational reference comparison at baseline. The essential oil-containing mouthrinses evaluated in this study showed statistically significant reductions in clinical gingivitis and plaque measurements when compared to the hydroalcohol control rinse after 6 weeks of use. CONCLUSIONS: By establishing a novel quantitative method for microbiome analysis, this study sheds light on the mechanisms of LCM mouthrinse efficacy on oral microbial ecology, demonstrating that repeated usage non-selectively resets a gingivitis-like oral microbiome toward that of a healthy oral cavity. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov on 10/06/2021. The registration number is NCT04921371.

Safety and efficacy of a novel toothbrush utilizing RF energy for the reduction of plaque, calculus and gingivitis.

PURPOSE: To evaluate the safety and efficacy of the ToothWave radiofrequency (RF) toothbrush in the reduction of plaque, calculus and gingival inflammation, as compared to a standard powered toothbrush accepted by the American Dental Association (ADA). METHODS: This was a single-blind, double arm, prospective study. Subjects were randomized to one of two treatment groups, receiving either the RF powered toothbrush or a control powered toothbrush, and performing twice daily brushing for a test period of 6 weeks. Plaque (RMNPI), calculus (V-MI), gingival inflammation (MGI) and bleeding (GBI) were assessed at baseline, after 4 and 6 weeks. Comparisons were completed both within and between each treatment group. Statistical analyses were conducted using the Mann Whitney non-parametric model. RESULTS: 85 subjects completed the study and had fully evaluable data. No significant differences between the groups were found in the baseline scores (P≥ 0.165). Following 6 weeks, the RF test group demonstrated statistically significant reductions in plaque, gingivitis and calculus compared to the control powered toothbrush (P≤ 0.001). Both toothbrushes were well-tolerated and no device-related adverse events were reported. The RF-utilizing powered toothbrush produced statistically significant reductions in dental plaque, calculus deposition, gingival inflammation and gingival bleeding as compared to a control powered toothbrush. CLINICAL SIGNIFICANCE: The RF powered toothbrush used twice daily resulted in an overall improvement in oral health.

Randomized Controlled Clinical Study to Determine the Oral and Dermal Tolerability of an Experimental Denture Wipe.

PURPOSE: To evaluate oral and dermal tolerance following use and user acceptability of an experimental denture-cleansing wipe. An exploratory objective was to develop a method to assess denture wipe effectiveness in removing debris from denture surfaces. MATERIALS AND METHODS: This was a single-center, randomized, controlled, parallel-group, examiner-blind study in participants with ≥1 full/partial denture. Participants were randomized to clean their dentures with the denture wipe (n = 76) or water (n = 76) up to 4 times per day for 14 days. Tolerability was assessed by treatment-emergent adverse events (TEAEs), oral soft tissue examination, and lead hand dermatological assessment. Acceptability was assessed by questionnaire. The feasibility of a methodology to assess the efficacy of the wipe at removing food particles was also evaluated through determination of the mass of chewed peanut particles that the wipe removed after a single use (n = 31). RESULTS: The proportion of participants experiencing oral TEAEs by day 14 was 0.039% with the denture wipe (lip injury [n = 1], mouth injury [n = 2]) and 0.013% with the water rinse (coated tongue [n = 1]). There were no dermal TEAEs and no TEAE-related study withdrawals. Skin irritation scores with the denture wipe remained unchanged from baseline. Comparing before vs. after cleaning with the denture wipe, a higher proportion of participants rated their dentures as feeling extremely/very fresh (28.9% pre-/85.5% post-cleaning), feeling extremely/very clean (34.2%/86.8%) and looking extremely/very clean (43.5%/85.5%). More denture-wipe group participants than water-rinse group participants were extremely/very satisfied with the amount of debris removed from their dentures (88.1% vs 72.4%). The methodology used to assess the weight of peanut particles captured from the wipes/dentures appeared to be a feasible investigation technique. CONCLUSIONS: The denture wipe was generally well-tolerated and had good user acceptability. The methodology for assessing the mass of peanut particles removed by denture wipes was successful.

A Comparison of the Effect of Two Power Toothbrushes on the Reduction of Gingival Inflammation and Supragingival Plaque.

OBJECTIVES: To compare the effect of the Philips Sonicare DiamondClean Smart and Oral-B Genius 8000 powered toothbrushes on gingivitis, gingival bleeding, and supragingival plaque reduction following 42 days of home use. METHODS: This was a randomized, parallel, examiner-blinded, prospective clinical trial with two treatment groups. Eligible participants were generally healthy volunteers who were manual toothbrush users, non-flossers, 18-65 years of age. The subject panel included non-smokers with = 50 sites of gingival bleeding according to the Gingival Bleeding Index (GBI), and a supragingival plaque score of = 1.8 per Modified Plaque Index (MPI) at 3-6 hours following last tooth brushing encounter. Eligible subjects were randomized to use either a Philips Sonicare DiamondClean Smart with Premium Plaque Control brush head (DCS) or an Oral-B Genius 8000 with FlossAction brush head (OBG) for home use. Each toothbrush was used twice daily for two minutes. All subjects used a standardized fluoride-containing dentifrice. All other oral hygiene measures were prohibited. Subjects returned at Day 14 for an interim compliance and safety assessment, and at Day 42 for the final safety and efficacy assessments. RESULTS: Of 222 enrolled and eligible subjects, 219 completed (112 in the SDC group, 107 in the OBG group) the study. The least squares (LS) mean and 95% confidence interval (CI) estimates for gingivitis reduction and percent reduction per Modified Gingival Index (MGI) following 42 days of product home use were 1.38 (1.30, 1.46) and 51.32% (48.45%, 54.19%) for DCS, and 0.53 (0.45, 0.61) and 20.07% (17.14%, 23.00%) for OBG. The differences, expressed as either reduction or percent reduction, were statistically significant between the two groups, p < 0.001. Statistically significant differences were also observed between products at Day 42 for the gingival bleeding and supragingival plaque reduction endpoints, p < 0.001. There were two reported adverse events. CONCLUSIONS: The Philips Sonicare DiamondClean Smart powered toothbrush reduced gingival inflammation, gingival bleeding, and supragingival plaque significantly more than the Oral-B Genius 8000 powered toothbrush following a 42-day home-use period. Both products were safe for use.

The Effects of Use of a Powered and a Manual Home Oral Hygiene Regimen on Plaque and Gum Health in an Orthodontic Population.

OBJECTIVES: The objective of this study was to compare the effect of two home use oral hygiene regimens on plaque, gingivitis, and gingival bleeding on subjects undergoing orthodontic treatment with fixed appliances. METHODS: This was a randomized, parallel, single-center clinical trial. Eligible study subjects fit the following profile: age 12-65 years; nonsmoker; plaque score of = 2.0 per Bonded Bracket Index (BBI) on dentition with fixed orthodontic hardware; minimum of 10 orthodontic brackets in each arch or on all teeth from first molar to first molar; presenting with mild to moderate gingivitis, defined as a score of = 1 on at least 20 sites per Gingival Bleeding Index (GBI). Subjects with advanced periodontal disease or gingival recession were not eligible. Eligible subjects were randomized to one of two home use oral hygiene regimens: manual toothbrush plus string floss (used with a threading device) for interdental cleaning (MTF regimen); or Philips Sonicare EasyClean power toothbrush with InterCare brush head and AirFloss Pro powered device, used with BreathRx mouthrinse for interdental cleaning (Sonicare Orthodontic Regimen or SOR). All subjects brushed twice daily with standard fluoridated dentifrice and performed interdental cleaning once daily. Efficacy and safety examinations were performed at Baseline and following three and six weeks of home use of the study products, and included assessments of BBI, GBI, Modified Gingival Index (MGI), and Modified Plaque Index (MPI). RESULTS: Of 228 enrolled subjects, 223 were included in the primary analysis. For the primary endpoint, reduction in BBI score following three weeks of product use, the overall least squares (LS) mean (95% CI) reduction was 0.89 (0.84, 0.95) for SOR and 0.06 (0.01, 0.12) for MTF. Expressed as percent reduction (95% CI) from Baseline, this was 33.1% (31.1%, 35.2%) for SOR and 2.01% (-0.06%, 4.07%) for MTF. The differences between regimens were statistically significant, p < 0.0001. Statistically significant differences between regimens were observed in BBI following six weeks of product use, and also for all other efficacy variables (GBI, MGI, MPI) at Week 3 and Week 6. CONCLUSIONS: The powered oral hygiene regimen was significantly more effective than a manual regimen in reducing plaque on bracketed and non-bracketed teeth, and in reducing gingival bleeding and gingival inflammation in orthodontic subjects following three weeks of use and persisting following six weeks of use. All products were safe on oral tissues and fixed orthodontic appliances.

A Randomized Parallel Study to Compare the Effects of Powered and Manual Tooth Brushing on Gingival Health and Plaque.

OBJECTIVES: To compare the effect of powered and manual tooth brushing on plaque and gingivitis following two and six weeks of home use. METHODS: This was a randomized, three-arm, parallel-design clinical trial. Eligible participants were manual toothbrush users who were generally healthy non-smokers, aged 18-65 years, with a plaque score of = 1.8 per Lobene and Soparkar Modified Plaque Index (MPI), and mild to moderate gingivitis, defined as a Gingival Bleeding Index (GBI) = 1 on at least 20 sites. Subjects with advanced periodontal disease, excessive gingival recession, and heavy deposits of calculus or rampant decay were excluded. Enrolled participants were randomly dispensed one of three devices: a powered toothbrush (Philips Sonicare DiamondClean Smart with Premium Gum Care brush head) used in either Gum Heath mode (DC-GH) or Clean mode (DC-C), or an ADA reference manual toothbrush (MTB). Efficacy and safety variables were assessed at Baseline, and at two and six weeks following twice-daily product home use. RESULTS: For the primary endpoint, reduction in gingivitis per Modified Gingival Index (MGI) at Week 2, 188 subjects completed and were included in the analysis. Expressed as percent reduction from Baseline, the adjusted mean reduction and Standard Error (SE) estimates were 60.31% (1.95%) for DC-GH, 53.08% (1.95%) for DC-C, and 16.59% (1.96%) for MTB. The difference between each power toothbrush group and the manual toothbrush was statistically significant (p < 0.0001). Statistically significant differences were also observed between DC-GH, DC-C, and manual tooth brushing for MGI at Week 6, as well as for MPI and GBI at Weeks 2 and 6. CONCLUSIONS: The powered toothbrush, used in either Gum Health or Clean mode, was statistically significantly superior to a manual tooth brush in reducing gingival inflammation, gingival bleeding, and plaque following two and six weeks of home use.

A Comparison of the Effects of a Powered and Manual Toothbrush on Gingivitis and Plaque: A Randomized Parallel Clinical Trial.

OBJECTIVES: To compare the effect of a powered and a manual toothbrush on gingivitis and plaque following two and four weeks of home use. METHODS: This was a randomized, parallel-design, single-blind clinical trial. Eligible participants were generally healthy non-smoking manual toothbrush users aged 18-65 years, with a plaque score of = 1.8 per Lobene and Soparkar Modified Plaque Index (MPI) following a 3-6 hour plaque accumulation period, and mild to moderate gingivitis defined as a Gingival Bleeding Index (GBI) = 1 on at least 20 sites. Subjects with advanced periodontal disease, xerostomia, excessive gingival recession, uncontrolled diabetes, and heavy deposits of calculus or rampant decay were excluded. Enrolled participants were randomly dispensed either a Philips Sonicare powered toothbrush used with the InterCare brush head (PTB) or an American Dental Association (ADA) reference manual toothbrush (MTB). Efficacy and safety variables were assessed at Baseline, and at two and four weeks following twice-daily product home use. The primary endpoint of the study was reduction of gingivitis per the Modified Gingival Index (MGI) after four weeks of home use. RESULTS: All 148 randomized subjects (74 per group) completed the study. A statistically significant difference in MGI reduction was observed between the two study groups (p < 0.001). The least square (LS) mean and standard error reduction from Baseline was 0.72 (0.04) for the PTB group compared to 0.09 (0.04) for the MTB group. Expressed as percent reduction from Baseline, the LS mean values were 35.77% (2.19%) and 4.22% (2.19%) for PTB and MTB, respectively. Statistically significant differences were also observed for MGI reduction at Week 2, as well as for MPI and GBI reduction at Weeks 2 and 4. CONCLUSIONS: The powered toothbrush was statistically significantly superior to a manual toothbrush in reducing gingival inflammation, gingival bleeding, and plaque following two and four weeks of home use.

An exploratory study to investigate stain build-up with long term use of a stannous fluoride dentifrice.

PURPOSE: To monitor extrinsic stain formation over 24 weeks with twice-daily use of an anhydrous 0.454% SnF2 dentifrice containing 5% sodium tripolyphosphate (STP) ('Test'), compared to a standard fluoride dentifrice (0.76% fluoride as sodium monofluorophosphate [SMFP\) ('Comparator') following a professional prophylaxis. METHODS: Primary efficacy variables were between-treatment differences in extrinsic dental stain of anterior teeth after 4, 8, 12, and 24 weeks' use using mean area and intensity scores of the MacPherson modification of the Lobene stain index (MLSI), and to monitor oral tolerability. RESULTS: Overall, 214 subjects were randomized to treatment. The Test dentifrice group demonstrated statistically significantly less stain compared with the Comparator at each timepoint for all outcome variables (MLSI - Area × Intensity, Area only, and Intensity only) with the exception of MLSI (Area × Intensity) at Week 12. Products were generally well tolerated with 26 treatment-related adverse events (TRAEs) reported (10 with Test, 16 with Comparator). Five subjects withdrew from the 24-week study due to TRAEs, three in the Test group, two in the Comparator group. Statistically significantly less anterior tooth staining was observed with up to 24 weeks twice-daily brushing with a 0.454% SnF2/5% STP anhydrous dentifrice compared to a marketed fluoride dentifrice with 0.76% SMFP. CLINICAL SIGNIFICANCE: Long term use of a SnF2/STP dentifrice demonstrated minimal stain build-up after 24 weeks, twice-daily use; products were generally well-tolerated.

Subgingival uptake and retention of stannous fluoride from dentifrice: Gingival crevicular fluid concentrations in sulci post-brushing.

PURPOSE: To examine the delivery of stannous fluoride to subgingival sulci following toothpaste use in a clinical population. METHODS: This was a controlled, single-site study. 23 subjects with at least 20 dental pockets, 2-4 mm with bleeding, who had not used a stannous fluoride dentifrice in the last 3 months were enrolled. After a 2-week washout period, 20 subjects returned for a baseline visit. They were instructed to refrain from brushing the night before the baseline visit. GCF samples were taken from up to 10 sites identified as sampling sites. Subjects were then given a 0.454% stannous fluoride dentifrice and soft manual toothbrush and asked to brush for 1 minute. 30 minutes after brushing, GCF was re-sampled. Subjects continued using the stannous fluoride dentifrice and soft manual toothbrush at home, twice daily for 2 weeks, in place of their usual hygiene products. At Days 1 and 14, subjects returned to the site, and 12 hours post-brushing GCF samples were taken. The samples were analyzed by ICP-MS (inductively coupled plasma mass spectrometry). A Wilcoxon signed-rank test was performed to determine the difference between post-baseline visits and baseline. Statistical tests were 2-sided using a 5% significance level. RESULTS: 20 subjects completed the trial. Significant levels of tin, a marker for stannous fluoride, were detected 30 minutes after brushing at sampling sites of 2-4 mm. The median tin level in gingival crevicular fluid (GCF) was 24.59 ng/µl, which was highly significant versus baseline (P< 0.0001). Tin levels sampled in GCF 12 hours after brushing on Days 1 and 14 were highly significant versus Baseline (P< 0.0001), showing an increasing trend with continued use. CLINICAL SIGNIFICANCE: Stannous fluoride was found to penetrate sampling sites from 2-4 mm and was retained for 12 hours. Subgingival uptake and retention of stannous fluoride following toothbrushing may play a role in detoxification effects on microbial biofilms and may contribute to the therapeutic efficacy of stannous fluoride dentifrices in promoting gingival health.

A randomized clinical trial to evaluate the stain removal efficacy of a sodium phytate dentifrice formulation.

OBJECTIVES: Phytate is an organic, cyclic polyphosphate analogous to linear condensed polyphosphates used as stain removal agents. This study investigated stain removal efficacy of an experimental sodium phytate-containing dentifrice compared to a reference dentifrice. METHODS: An experimental, moderate abrasivity (relative dentine abrasivity [RDA] âˆ¼130) antisensitivity fluoride dentifrice containing sodium phytate (0.85% w/w as the hexasodium salt) (n = 111) was compared to a reference, marketed, low-abrasivity (RDA âˆ¼ 43), anti-sensitivity fluoride dentifrice (n = 113), both containing 1150 ppm fluoride as sodium fluoride. Primary efficacy variables were between-treatment differences in extrinsic dental stain of anterior teeth after 6 and 12 weeks' twice-daily use, using Lobene stain index (MacPherson modification, MLSI) mean area (A) and intensity (I) scores. Comparisons included whole-tooth and hard-to-reach areas (gingival, interproximal, body of lingual). RESULTS: At both 6- and 12-week timepoints, MLSI (A × I) scores for total area and hard-to-reach areas for the experimental dentifrice were statistically significantly lower than baseline (P < .0001 for all). This was demonstrated for the reference dentifrice at 6 weeks only, for total, interproximal (P < .0001 for both), and body of lingual (P = .0395) scores. Compared with the reference, the experimental dentifrice had statistically significantly lower MLSI scores at both 6 and 12 weeks for all outcome variables including both total MLSI (A × I) and hard-to reach areas (P < .0001 in all cases). Products were generally well-tolerated. CONCLUSIONS: Differences between treatments were considered clinically differentiable. Sodium phytate may therefore be a suitable additive ingredient to improve tooth stain control performance within an otherwise conventional dentifrice formulation. CLINICAL SIGNIFICANCE: Following 6 and 12 weeks brushing, clinically differentiable differences were shown in stain index scores with an experimental dentifrice containing sodium phytate compared to a reference dentifrice without sodium phytate. Sodium phytate may therefore be a suitable additive ingredient to improve tooth stain control performance within an otherwise conventional dentifrice formulation.

Six-Month Evaluation of a Sodium Bicarbonate-Containing Toothpaste for Reduction of Established Gingivitis: A Randomized USA-Based Clinical Trial.

OBJECTIVES: Short-term use of sodium bicarbonate (NaHCO3)-containing toothpaste reduces plaque and improves clinical measures of gingivitis. To examine this over a longer period, we compared efficacy and tolerability of twice-daily brushing for 24 weeks with 67% or 0% NaHCO3-containing toothpastes in USA-based participants with moderate gingivitis (Clinicaltrials.gov:NCT02207400). METHODS: This was a six-month, randomized, examiner-blind, parallel-group, clinical trial. Investigators randomized adults with blood in expectorate after brushing and ≥ 20 gingival bleeding sites to 67% NaHCO3 (n = 123; n = 107 completed study) or 0% NaHCO3 (n = 123; n = 109 completed study) toothpastes. Primary efficacy variables included between-treatment differences in number of bleeding sites and Modified Gingival Index (MGI) score at 24 weeks. Secondary efficacy variables included Bleeding Index and Turesky modification of the Quigley-Hein Plaque Index (overall and interproximal sites) at six, 12, and 24 weeks. A subset of 50 participants underwent sampling to assess plaque microbiology over the course of treatment. RESULTS: Compared with the 0% NaHCO3 toothpaste, the 67% NaHCO3 toothpaste produced statistically significant improvements at Week 24 in number of bleeding sites (46.7% difference) and MGI (33.9% difference), and for all other endpoints (all p < 0.0001). There was no significant between-treatment difference in the proportion of participants harboring opportunistic pathogens. Products were generally well tolerated, with two and five treatment-related adverse events reported in the 67% and 0% NaHCO3 toothpaste groups, respectively. CONCLUSIONS: Gingival bleeding, gingivitis, and plaque indices were significantly improved at six, 12, and 24 weeks with twice-daily brushing with 67% NaHCO3-containing toothpaste in participants with moderate gingivitis.

A randomized clinical study to evaluate the effect of an ultra-low abrasivity dentifrice on extrinsic dental stain.

PURPOSE: To investigate the stain-removal efficacy of an experimental ultra-low abrasivity anti-sensitivity dentifrice containing sodium tripolyphosphate (STP) and a cocamidopropyl betaine/sodium methyl cocoyl taurate detergent system. METHODS: This was a single-center, examiner-blind, randomized, parallel-group study. Extrinsic dental stain was assessed on the facial surfaces of the six maxillary and six mandibular anterior teeth and the lingual surfaces of the six mandibular anterior teeth using the Macpherson modification of the Lobene Stain Index (MLSI). Treatments were: ultra-low abrasivity dentifrice [5% w/w KNO3, 5% w/w STP, 1,100 ppm fluoride as sodium fluoride; relative dentin abrasivity (RDA) ~10; n=54]; moderate abrasivity fluoride dentifrice (1,100 ppm fluoride as sodium monofluorophosphate; RDA ~68; n= 57); higher abrasivity daily-use whitening dentifrice (1,100 ppm fluoride as sodium fluoride; RDA~137; n= 57). Subjects brushed for 1 minute, twice daily, for 8 weeks. RESULTS: Mean total MLSI [ Area × Intensity (A×I) ] change from baseline score at Weeks 4 and 8 was significant (P< 0.0001) for all groups. At Week 8, for the ultra-low abrasivity dentifrice versus the moderate and higher abrasivity dentifrices, mean total MLSI (A×I) scores (P< 0.0001), along with MLSI endpoints in facial, lingual, and interproximal regions (P= 0.0035 to P< 0.0001), favored the ultra-low abrasivity dentifrice. Dentifrices were generally well-tolerated. The ultra-low abrasivity dentifrice containing 5% STP reduced extrinsic dental stain more effectively than moderate or higher abrasivity dentifrices. CLINICAL SIGNIFICANCE: The ultra-low abrasivity, anti-sensitivity dentifrice containing 5% STP reduced extrinsic dental stain more effectively than moderate or higher abrasivity dentifrices, and is thus suitable for patients with sensitive teeth who wish to control extrinsic dental stain.

An induced extrinsic tooth stain prevention model to investigate whitening potential of sugar-free chewing gums.

PURPOSE: To establish an accelerated clinical test method to evaluate the effectiveness of sugar-free gums in prevention of the formation of extrinsic stains when chewed over a 2-week period in conjunction with daily tooth brushing. A secondary objective was to compare three methods for measuring extrinsic stain. METHODS: 25 healthy adult volunteers were enrolled in a single center, examiner blind, randomized 4-way crossover clinical study. Starting with a stain-free baseline, subjects rinsed five times daily with freshly brewed black tea, followed either by chewing one of three different gums for 12 minutes or not chewing (negative control). Extrinsic stain was measured at 1 and 2 weeks by modified Lobene Stain Index (MLSI), digital imaging, and a Vita EasyShade spectrophotometer. RESULTS: At 2 weeks, MLSI scores showed a statistically significant mean reduction of 43% or greater versus no-gum control for all three gum treatments. Digital image analysis and Vita EasyShade measurement showed reductions of yellowness (measured by difference in ∆b* values between the three gums and the non-gum control treatment) ranging from 0.28 to 0.34 and 3.52 to 4.18 Δb* units, respectively, for subjects using the chewing gums versus no-gum control (P< 0.05) after 2 weeks. This clinical study demonstrated that sugar-free gum can effectively reduce new stain formation along with daily tooth brushing in as little as 2 weeks when used in conjunction with tea rinsing to help promote more rapid stain formation. All three test methods confirmed the results, albeit with different levels of statistical significance. A minor modification of gum base polymer, or change of flavors, did not significantly impact the prevention of new stain formation. CLINICAL SIGNIFICANCE: Regular consumption of sugar-free chewing gum helps prevent extrinsic dental stain accumulation and provides a simple and enjoyable means for consumers to maintain their natural tooth color.

Randomized Controlled Trial to Explore the Effect of Experimental Low Abrasivity Dentifrices on Enamel Gloss and Smoothness, and the Build-up of Extrinsic Tooth Stain.

OBJECTIVES: To evaluate and compare examiner-assessed changes in enamel gloss, extrinsic dental stain, and surface smoothness following one, two, four, and eight weeks of twice-daily use of an experimental low abrasivity desensitizing dentifrice (relative dentin abrasivity [RDA] ~40) containing 5% sodium tripolyphosphate (STP) chemical cleaning agent and 1% aluminum trioxide abrasive. This was compared with an ultra-low abrasivity dentifrice (5% STP only; RDA ~13), a moderate abrasivity fluoride dentifrice (RDA ~80), and a higher abrasivity marketed whitening dentifrice (RDA ~142). METHODS: This was a single-center, examiner-blind, randomized, controlled, parallel group study in healthy adults stratified by gloss score and age. Following a washout period with a conventional silica abrasive dentifrice, subjects received a dental scale and polish and were randomized to treatment. Subjects brushed their teeth for two minutes, twice daily, with their assigned dentifrice. Enamel gloss was assessed visually by comparing the facial surfaces of the maxillary incisors to the Sturzenberger gloss standards. Extrinsic dental stain was measured on the 12 anterior teeth (facial and lingual) using the Macpherson modification of the Lobene Stain Index (MLSI). Tooth smoothness was assessed using scanning electron microscope (SEM) analysis of a silicone impression of the central incisors. RESULTS: Of 120 screened subjects, 95 were randomized to the study. Subjects using the low abrasivity aluminum trioxide/STP dentifrice demonstrated statistically significant (p < 0.05) and increasing improvements in surface gloss over baseline at all time points, with a significant treatment effect compared to all other study dentifrices from Week 2 (p < 0.05). With respect to dental stain, the low abrasivity dentifrice group had the lowest stain score at each post-treatment time point and demonstrated statistically significantly less stain compared to all study dentifrices at Weeks 2 (p < 0.05) and 8 (p < 0.01). For tooth smoothness, at Week 8, statistically significant increases in surface smoothness were observed for most treatment groups compared to baseline (p < 0.05), except for the moderate abrasivity dentifrice. CONCLUSIONS: This study shows the benefit of a low abrasivity dentifrice containing STP and aluminum trioxide in reducing stain build-up and increasing tooth gloss compared to a non-alumina ultra-low abrasivity STP-containing dentifrice, and moderate and high abrasivity dentifrices, over an eight-week period.

An Evaluation of Plaque and Gingivitis Reduction Following Home Use of Sonicare FlexCare Platinum with Premium Plaque Control Brush Head and a Manual Toothbrush.

OBJECTIVES: To assess the effect of the Philips Sonicare FlexCare Platinum with Premium plaque control brush head on gingival inflammation, bleeding, and supragingival plaque reduction following a six-week period of home use compared to a manual toothbrush. METHODS: This was a randomized, single-blind, parallel-design clinical trial. Subjects included in the study were routine manual toothbrush users who were generally healthy non-smokers, aged 18-65 years, with mild to moderate gingivitis. Subjects with advanced periodontal disease, excessive gingival recession, and heavy deposits of calculus or rampant decay were excluded from the study. Eligible participants were dispensed either Philips Sonicare FlexCare Platinum with Premium plaque control brush head (PC), or an ADA Reference manual toothbrush (MTB) for twice-daily home oral hygiene procedures for six weeks. Efficacy measures included the Lobene and Soparker Modification of Quigley and Hein Plaque Index (MPI), the Modified Gingival Index (MGI), and Gingival Bleeding Index (GBI). Safety was evaluated by oral examination and subject report. Efficacy and safety were assessed at Baseline, and at two and six weeks following product home use. RESULTS: Of 154 subjects randomized, 143 subjects completed the study. For the primary endpoint, MGI at Week 2, statistically significantly larger reductions in MGI were observed for PC versus MTB, p < 0.0001. The adjusted mean reduction and standard error estimates (SE) for MGI, expressed as percent reduction versus Baseline to Week 2, were 41.73% (2.00%) for PC and 7.38% (2.02%) for MTB. Statistically significant differences were also observed for MPI and GBI at Week 2, and for all metrics at Week 6. CONCLUSIONS: Philips Sonicare FlexCare Platinum with Premium plaque control brush head statistically significantly reduces gingival inflammation, gingival bleeding, and plaque following two and six weeks of home use, compared to manual tooth brushing alone.

A Comparison of the Effect of Two Power Toothbrushes on the Gingival Health and Plaque Status of Subjects with Moderate Gingivitis.

OBJECTIVES: To compare the effect of the Philips Sonicare DiamondClean plus Premium plaque control brush head with the Oral-B 7000 plus CrossAction brush head on gingivitis and supragingival plaque reduction following a 42-day period of home use. METHODS: This was a randomized, parallel, examiner-blind, prospective clinical trial conducted on generally healthy subjects. Eligible subjects met the following eligibility criteria: age 18-65, non-smoker, routine manual toothbrush user, ≥ 50 sites of gingival bleeding per the Gingival Bleeding Index (GBI), and ≥ 1.8 plaque score per the Modified Plaque Index (MPI), assessed three to six hours following the last oral hygiene procedure. Eligible subjects were enrolled in the study and randomly assigned to use either a Philips Sonicare DiamondClean with Premium plaque control brush head power toothbrush (SPC) or an Oral-B® 7000 with CrossAction™ brush head power toothbrush (OCA), for twice daily home use over a period of 42 days. All subjects were dispensed a standard fluoride-containing dentifrice and both toothbrushes were to be used in their respective Deep Clean modes. Safety and efficacy evaluations were performed at 14 and 42 days following Baseline. RESULTS: Two-hundred eighty-four subjects completed this trial (142 subjects per treatment group). Least squares mean (95% CI) estimates for reduction and percent reduction of gingivitis per Modified Gingival Index (MGI) following 42 days of product use for the SPC group were 1.17 (1.10, 1.24) and 45.68% (42.95%, 48.40%); for the OCA group they were 0.69 (0.62, 0.76) and 26.83% (24.10%, 29.56%). The mean difference (95% CI) between the two treatment groups was 0.48 (0.38, 0.58) and 18.85% (14.99%, 22.70%) for reduction and percent reduction, respectively. The lower limit of the 95% CI for the difference in Overall score between the two treatment groups was greater than the predefined non-inferiority margin (i.e., -0.10 or -5%); therefore SPC was declared non-inferior to OCA. In addition, since the 95% CI for the difference did not include zero, SPC was declared superior to OCA in the reduction of gingivitis per MGI at Day 42 (p-value < 0.0001). Similarly, for MGI at Day 14 and for GBI and MPI at Day 14 and Day 42, significantly larger reductions were observed for SPC compared to OCA (p-value < 0.0001). CONCLUSIONS: Philips Sonicare DiamondClean with Premium plaque control brush head (SPC) was statistically superior to the Oral-B 7000 with CrossAction brush head (OCA) in reducing gingival inflammation, gingival bleeding, and supragingival plaque following 14 and 42 days of home use. Both products were safe for use.

The Effect of Use of a Sonic Power Toothbrush and a Manual Toothbrush Control on Plaque and Gingivitis.

OBJECTIVES: To compare the ability of the Philips Sonicare DiamondClean power toothbrush and the ADA Reference manual toothbrush to reduce plaque and gingival inflammation by routine manual toothbrush users. METHODS: This was a randomized, single-blind, parallel-design study. Eligible subjects were generally healthy non-smokers who exhibited mild to moderate gingivitis upon study entry. Enrolled subjects were randomly allocated to commence twice-daily home use of either a Philips Sonicare DiamondClean (DiamondClean) power toothbrush or an ADA reference manual toothbrush (MTB) for a period of four weeks. Clinical safety and efficacy were assessed after a two- and four-week period of home use. Statistical analysis was performed for the modified intent to treat (mITT) population using a mixed model with the Baseline score as a covariate. RESULTS: A total of 182 volunteers were screened, 144 (72 per treatment) were randomized, and 142 subjects completed this study. Following four weeks of use, the Least Square (LS) Mean SE) percent reduction in surface plaque was 34.9% (1.8) for DiamondClean and 8.0% (1.7) for MTB, (p < 0.0001). At the same four-week time point, the LS Mean (SE) percent reduction in gingival inflammation for DiamondClean was 25.5% (1.9) and 19.1% (1.9) for MTB (p = 0.0213). For gingival bleeding, the LS Mean (SE) percent reduction in sites with gingival bleeding for DiamondClean was 57.4% (3.06) and 31.4% (3.04) for MTB (p < 0.0001). CONCLUSIONS: The Philips Sonicare DiamondClean power toothbrush was statistically significantly more effective than a manual toothbrush in reducing supragingival plaque, gingival inflammation, and gingival bleeding following a four-week period of home use. Both products were safe for home use.

A Randomized Clinical Study to Evaluate the Effect of Two Experimental Toothpastes on Tooth Enamel Gloss and Smoothness.

OBJECTIVES: The study compared the effects on examiner-assessed tooth gloss and smoothness of two experimental toothpastes (1% or 2% alumina abrasive) with a reference, silica-based toothpaste used twice daily for one, four, and eight weeks. The study also monitored the safety of the products. METHODS: This was a randomized, examiner-blind study, stratified by gloss score and age, three-treatment, parallel-group using healthy adult volunteers. Following a two-week washout period where subjects brushed with a conventional silica-abrasive toothpaste, 169 subjects began the trial period after receiving a dental scaling and polishing using the washout toothpaste. Subjects brushed for two minutes, twice daily, with their assigned toothpaste. The experimental toothpastes contained 927 ppm fluoride as NaF with either 1% or 2% alumina as the sole abrasive. The reference toothpaste contained 927 ppm fluoride as NaF in a conventional amorphous silica abrasive base. Enamel polish (i.e., gloss) was assessed visually by comparing the facial surfaces of the maxillary incisors with a set of standards. Tooth smoothness was assessed by lightly dragging a dental explorer over the surface. RESULTS: Subjects using the 2% alumina toothpaste had significantly higher gloss compared to the reference toothpaste at Weeks 1 and 4, but the difference was of borderline significance at Week 8 (one-covariate analysis: p = 0.0529; two-covariate analysis: p = 0.0494). Subjects using the 1% alumina toothpaste had significantly higher gloss improvement scores than the reference toothpaste at Weeks 4 and 8, but not at Week 1. All three treatment groups' gloss scores improved during the study. Regarding tooth smoothness, the effects of the experimental toothpastes followed a broadly similar profile to the effects on tooth gloss. After four weeks' use, both experimental toothpastes were superior to the reference. After eight weeks' use, however, only the 2% alumina toothpaste approached significant superiority versus the reference (p = 0.0639). CONCLUSIONS: The 1% and 2% alumina toothpastes improved tooth gloss compared to a standard silica toothpaste when used twice daily for two minutes over an eight-week study period. Furthermore, there was evidence of a corresponding increase in tooth smoothness.