Beta-defensin index: A functional biomarker for oral cancer detection.

There is an unmet clinical need for a non-invasive and cost-effective test for oral squamous cell carcinoma (OSCC) that informs clinicians when a biopsy is warranted. Human beta-defensin 3 (hBD-3), an epithelial cell-derived anti-microbial peptide, is pro-tumorigenic and overexpressed in early-stage OSCC compared to hBD-2. We validate this expression dichotomy in carcinoma in situ and OSCC lesions using immunofluorescence microscopy and flow cytometry. The proportion of hBD-3/hBD-2 levels in non-invasively collected lesional cells compared to contralateral normal cells, obtained by ELISA, generates the beta-defensin index (BDI). Proof-of-principle and blinded discovery studies demonstrate that BDI discriminates OSCC from benign lesions. A multi-center validation study shows sensitivity and specificity values of 98.2% (95% confidence interval [CI] 90.3-99.9) and 82.6% (95% CI 68.6-92.2), respectively. A proof-of-principle study shows that BDI is adaptable to a point-of-care assay using microfluidics. We propose that BDI may fulfill a major unmet need in low-socioeconomic countries where pathology services are lacking.

Efficacy of dental evacuation systems for aerosol exposure mitigation in dental clinic settings.

Dental personnel are ranked among the highest risk occupations for exposure to SARS-CoV-2 due to their close proximity to the patient's mouth and many aerosol generating procedures encountered in dental practice. One method to reduce aerosols in dental settings is the use of intraoral evacuation systems. Intraoral evacuation systems are placed directly into a patient's mouth and maintain a dry field during procedures by capturing liquid and aerosols. Although multiple intraoral dental evacuation systems are commercially available, the efficacy of these systems is not well understood. The objectives of this study were to evaluate the efficacy of four dental evacuation systems at mitigating aerosol exposures during simulated ultrasonic scaling and crown preparation procedures. We conducted real-time respirable (PM4) and thoracic (PM10) aerosol sampling during ultrasonic scaling and crown preparation procedures while using four commercially available evacuation systems: a high-volume evacuator (HVE) and three alternative intraoral systems (A, B, C). Four trials were conducted for each system. Respirable and thoracic mass concentrations were measured during procedures at three locations including (1) near the breathing zone (BZ) of the dentist, (2) edge of the dental operatory room approximately 0.9 m away from the mannequin mouth, and (3) hallway supply cabinet located approximately 1.5 m away from the mannequin mouth. Respirable and thoracic mass concentrations measured during each procedure were compared with background concentrations measured in each respective location. Use of System A or HVE reduced thoracic (System A) and respirable (HVE) mass concentrations near the dentist's BZ to median background concentrations most often during the ultrasonic scaling procedure. During the crown preparation, use of System B or HVE reduced thoracic (System B) and respirable (HVE or System B) near the dentist's BZ to median background concentrations most often. Although some differences in efficacy were noted during each procedure and aerosol size fraction, the difference in median mass concentrations among evacuation systems was minimal, ranging from 0.01 to 1.48 µg/m3 across both procedures and aerosol size fractions.

Longitudinal assessment of a Dental and Medical Student Service program in Appalachia: Successes and lessons learned.

OBJECTIVES: Recruiting/retaining healthcare professionals within rural and underserved communities in the United States remains a challenge. The West Virginia University Institute for Community and Rural Health implemented a service scholarship program in 2011 to address a lack of dental and primary care. METHODS: Dental and medical students commit to practice 12-months full time following graduation in a Health Profession Shortage Area (HPSA) or Rural Urban Commuting Area (RUCA) in West Virginia for each $25,000 received. RESULTS: Since inception of the program, 20 of 23 (87 percent) dental recipients had completed their service commitment, 17 (85 percent) are still practicing in WV, and 3 (13 percent) are fulfilling their commitment. Four of 20 medical recipients have repaid (2) or fulfilled (2) program commitments and 16 are completing commitments or deferred during training. Retention rate is 82 percent for both dental and medical professionals following program completion. CONCLUSIONS: Service scholarships effectively engage students to provide care in rural/underserved areas and remain there after program completion.

No benefit of an adjunctive phototherapy protocol in treatment of periodontitis: A split-mouth randomized controlled trial.

AIM: To assess the efficacy of a commercially available adjunctive phototherapy protocol ("Perio-1") in treatment of periodontitis. MATERIALS AND METHODS: In an examiner-blind, randomized, controlled, split-mouth, multicentre study, 60 periodontitis patients received root surface debridement (RSD) in sextants either alone (control sextants) or with the adjunctive phototherapy protocol (test sextants). Re-evaluation was performed at 6, 12 and 24 weeks. RESULTS: No statistically significant differences in mean (± standard deviation) clinical attachment level (CAL) change from baseline to week 24 were observed between test (-1.00 ± 1.16 mm) and control sextants (-0.87 ± 0.79 mm) at sites with probing pocket depths (PPDs) ≥5 mm ("deep sites") at baseline (p = .212). Comparisons between test and control sextants for all other parameters (CAL change at all sites, PPD change at deep sites/all sites, bleeding on probing, plaque scores), and for all change intervals, failed to identify any statistically significant differences. CONCLUSIONS: The phototherapy protocol did not provide any additional clinical benefits over those achieved by RSD alone. (German Clinical Trials Register DRKS00011229).

Effects of a toothpaste containing 0.3% triclosan on periodontal parameters of subjects enrolled in a regular maintenance program: A secondary analysis of a 2-year randomized clinical trial.

BACKGROUND: The triclosan-containing dentifrices are effective in controlling biofilm formation and maintaining gingival health; however, there is limited information on their effects during the periodontal maintenance phase. Therefore, the aim of this study was to evaluate the clinical effects of a toothpaste containing 0.3% triclosan on the periodontal parameters of subjects that have been treated for peri-implantitis and were enrolled in a regular maintenance program. METHODS: Subjects presenting at least one implant with peri-implantitis and received surgical anti-infective therapy were selected. Sixty days post-surgery (baseline), subjects were randomized into two groups: (1) toothpaste containing 0.3% triclosan + 2.0% PVM/MA copolymer + 1450 ppm fluoride (test) or (2) toothpaste containing 1450 ppm fluoride (control), and were instructed to brush with the assigned toothpaste twice/day for 2 years. They received clinical monitoring at baseline, 3, 6, 12, 18, and 24 months, and professional maintenance every 3 months. RESULTS: Eighty-eight subjects with natural teeth were enrolled in the study (Test, n = 39; Control, n = 49). The test group showed a greater reduction in the percentage of sites exhibiting bleeding on probing (primary outcome) and lower levels of plaque in comparison with the control group after 24 months (P < 0.05). The mean percentage of sites with probing depth ≥5 mm was reduced over the course of the study only in the test group (P < 0.05). CONCLUSION: A toothpaste containing 0.3% triclosan was more effective than a regular fluoride toothpaste in improving the periodontal clinical condition around natural teeth of periodontally healthy subjects enrolled in a regular maintenance program for 2 years.

U.S. Re-Licensure Opioid/Pain Management Continuing Education Requirements in Dentistry, Dental Hygiene, and Medicine.

Drug-induced deaths have been accelerating over the last two decades. The aim of this study was to determine if states with high opioid-induced deaths and overall drug-induced deaths were more likely to have continuing education (CE) requirements related to opioid use/pain management than states with fewer opioid-induced deaths. Almost 200 state dental and medical law boards' websites were examined for CE requirements, license renewal periods, and CE requirements for opioid use/pain management in December 2018 and January 2019. Drug-induced death data were obtained from the Centers for Disease Control and Prevention online database. States were categorized into quartiles of opioid-induced deaths per 100,000 population. A similar categorization was created for all drug-induced deaths. The results showed that states in the second, third, and fourth quartiles of opioid-induced deaths were more likely to have dental boards requiring opioid use/pain management CE than states in the first quartile in dentistry. This pattern was not the case with the medical boards' requirements. Dentists and physicians in states with higher all drug-induced deaths per 100,000 population were as likely to be required to attend opioid use/pain management CE as dentists and physicians in states with lower opioid-induced deaths. Although many licensing boards require opioid use/pain management CE in relation to their opioid-induced death rates, there is a need for policies to increase education in substance use disorders to reduce the number of drug-induced deaths.

Effects of a toothpaste containing 0.3% triclosan in the maintenance phase of peri-implantitis treatment: 2-Year randomized clinical trial.

OBJECTIVE: To evaluate the effects of a toothpaste containing 0.3% triclosan in volunteers that have been treated for peri-implantitis and were enrolled in a maintenance program. MATERIAL AND METHODS: Subjects presenting at least one implant with peri-implantitis were selected. They received anti-infective surgical therapy, and sixty days post-surgery (baseline) were randomized into two groups, brushing twice/day for 2 years (a) with a toothpaste containing 0.3% triclosan+2.0% PVM/MA copolymer (GantrezTM )+1,450 ppm fluoride (test) or (b) with a toothpaste containing 1,450 ppm fluoride (control). They received clinical and microbiological monitoring at baseline, 3, 6, 12, 18, and 24 months, and professional maintenance every 3 months. RESULTS: A total of 102 subjects were enrolled (test: 48; control: 54). The control group showed loss of clinical attachment (CA) around treated implants over the course of the study (p < 0.05), while the test group was stable for this parameter. The difference between groups (0.55 mm) for CA change between baseline and 24 months (primary outcome variable) was statistically significant (p < 0.05). Red complex pathogens were only reduced in the test group at 24 months. The implants with no history of peri-implantitis in the test group had a significant reduction in the percentage of sites with bleeding on probing and in mean probing depth, throughout the study (p < 0.05). This improvement was not observed in the control group. CONCLUSION: A toothpaste containing 0.3% triclosan was more effective than a toothpaste without triclosan in maintaining a healthy peri-implant environment around treated implants and implants with no history of peri-implantitis during a 2-year maintenance program (ClinicalTrials.govNCT03191721).

Effects of triclosan on host response and microbial biomarkers during experimental gingivitis.

AIM: This exploratory randomized, controlled clinical trial sought to evaluate anti-inflammatory and -microbial effects of triclosan during experimental gingivitis as assessed by host response biomarkers and biofilm microbial pathogens. MATERIALS AND METHODS: Thirty participants were randomized to triclosan or control dentifrice groups who ceased homecare for 21 days in an experimental gingivitis (EG) protocol. Plaque and gingival indices and saliva, plaque, and gingival crevicular fluid (GCF) were assessed/collected at days 0, 14, 21 and 35. Levels and proportions of 40 bacterial species from plaque samples were determined using checkerboard DNA-DNA hybridization. Ten biomarkers associated with inflammation, matrix degradation, and host protection were measured from GCF and saliva and analysed using a multiplex array. Participants were stratified as "high" or "low" responders based on gingival index and GCF biomarkers and bacterial biofilm were combined to generate receiver operating characteristic curves and predict gingivitis susceptibility. RESULTS: No differences in mean PI and GI values were observed between groups and non-significant trends of reduction of host response biomarkers with triclosan treatment. Triclosan significantly reduced levels of A. actinomycetemcomitans and P. gingivalis during induction of gingivitis. CONCLUSIONS: Triclosan reduced microbial levels during gingivitis development (ClinicalTrials.gov NCT01799226).

Control of dentin/root sensitivity during non-surgical and surgical periodontal treatment.

AIM: To determine the efficacy of a desensitizing regimen compared to a control in preventing the occurrence and/or alleviating dentin/root sensitivity (DRS) following non-surgical (NSPT) and surgical periodontal treatment (SPT). METHODS: Seventy-four chronic-periodontitis patients (CPP) were randomized into a test group (n = 38) using an in-office prophylaxis paste and a toothpaste at home both containing 8% arginine and calcium carbonate (Pro-Argin(™) Technology) or into a control group (n = 36) receiving a fluoride-free prophylaxis paste and a fluoride toothpaste. The examiner applied the assigned paste onto selected teeth for 3 s following NSPT and for 60 s before flap closure. Patients brushed with the assigned toothpaste twice daily throughout the study. DRS to air stimulus was assessed by the Schiff scale (0-3) and the Visual Analog Scale (VAS: 0-100 mm) six times over 17 weeks. RESULTS: In the test group, VAS scores significantly decreased at 8, 11 and 17 weeks from baseline (p ≤ 0.003) and Schiff scores at 8 and 11 weeks from baseline (p ≤ 0.014). The control group exhibited significant increases in VAS and Schiff during the study period (p ≤ 0.006). Marked inter-group differences were noted at all time points (p < 0.001). CONCLUSIONS: The combined use of desensitizing products (8% arginine and calcium carbonate) in-office and at-home prevented DRS development and maintained this effect for 17 weeks following NSPT and SPT.

Dental hygienists' evaluation of the usability research study of the Colgate ProClinical A1500 electric toothbrush.

OBJECTIVE: To determine the user experiences among patients of a new electric toothbrush vs. a manual toothbrush. METHODS: Five dental hygienists were selected to review videotapes demonstrating patient use of their manual toothbrush and the Colgate ProClinical A1500 electric toothbrush. A total of 14 users were videotaped during the three-week duration of this observational study. The dental hygienists were asked to review four assigned user videotapes and then complete a four-page questionnaire sheet for each of them. Each patient participant was reviewed by at least two dental hygienists. RESULTS: The results provide an understanding that there may be differences in the length of time that patients brush their teeth with their manual toothbrush vs. this electric toothbrush. The users of the electric toothbrush appeared to brush in a more concentrated and focused tooth brushing pattern vs. the manual brush. The users did become accustomed to using this electric toothbrush over time and felt an improvement in cleaning efficacy with the product. The observations from the five dental hygienists were consistent with the results of a previously published usability study. CONCLUSION: The Colgate ProClinical A1500 electric toothbrush, relative to a manual toothbrush, provided an improved brushing experience for the fourteen users whose brushing techniques were evaluated by five dental hygienists who reviewed their videotapes from the usability study.

Randomized controlled trial comparing a powered toothbrush with distinct multi-directional cleaning action to a manual flat trim toothbrush.

PURPOSE: To compare the plaque and gingivitis efficacy of a power toothbrush with distinct multi-directional cleaning action (Colgate® ProClinical® A1500 Power Toothbrush) against a manual flat-trim toothbrush (Oral-B Indicator). METHODS: This randomized control trial was a single-center, examiner-blind, parallel-group, design and assessed plaque removal after a single brushing, as well as plaque removal and gingivitis reduction after 4 weeks and 12 weeks of brushing. Qualifying subjects used their assigned toothbrush to brush their teeth under supervision after which they were evaluated for plaque (post-brushing). Over the next 12 weeks, subjects brushed unsupervised at home with their assigned toothbrush. After 4 weeks and 12 weeks, subjects returned to the center for plaque and gingivitis examinations. RESULTS: 80 subjects were screened for eligibility and randomized into the study. 79 subjects completed the study. Both toothbrushes provided statistically significant reductions in all plaque index scores at all time points in comparison to the pre-brushing scores. After 4 weeks and 12 weeks, statistically significant reductions in gingivitis and gingivitis severity scores were observed for subjects using the power toothbrush, whereas statistically significant increases in gingivitis and gingivitis severity were observed for subjects using the manual toothbrush. In conclusion, relative to the manual toothbrush, the power toothbrush provided statistically significantly (P < 0.05) greater removal of plaque: whole-mouth (131%), gumline (97.4%), and interproximal (220%), as well as reductions in gingivitis (400%), and gingivitis severity (320%) after 12 weeks of use. Compared to the manual flat-trim toothbrush, the power toothbrush with distinct multi-directional cleaning action demonstrates statistically and clinically significantly greater levels of plaque removal and gingivitis reduction at all time points.

Global metabolomic analysis of human saliva and plasma from healthy and diabetic subjects, with and without periodontal disease.

Recent studies suggest that periodontal disease and type 2 diabetes mellitus are bi-directionally associated. Identification of a molecular signature for periodontitis using unbiased metabolic profiling could allow identification of biomarkers to assist in the diagnosis and monitoring of both diabetes and periodontal disease. This cross-sectional study identified plasma and salivary metabolic products associated with periodontitis and/or diabetes in order to discover biomarkers that may differentiate or demonstrate an interaction of these diseases. Saliva and plasma samples were analyzed from 161 diabetic and non-diabetic human subjects with a healthy periodontium, gingivitis and periodontitis. Metabolite profiling was performed using Metabolon's platform technology. A total of 772 metabolites were found in plasma and 475 in saliva. Diabetics had significantly higher levels of glucose and α-hydroxybutyrate, the established markers of diabetes, for all periodontal groups of subjects. Comparison of healthy, gingivitis and periodontitis saliva samples within the non-diabetic group confirmed findings from previous studies that included increased levels of markers of cellular energetic stress, increased purine degradation and glutathione metabolism through increased levels of oxidized glutathione and cysteine-glutathione disulfide, markers of oxidative stress, including increased purine degradation metabolites (e.g. guanosine and inosine), increased amino acid levels suggesting protein degradation, and increased ω-3 (docosapentaenoate) and ω-6 fatty acid (linoleate and arachidonate) signatures. Differences in saliva between diabetic and non-diabetic cohorts showed altered signatures of carbohydrate, lipid and oxidative stress exist in the diabetic samples. Global untargeted metabolic profiling of human saliva in diabetics replicated the metabolite signature of periodontal disease progression in non-diabetic patients and revealed unique metabolic signatures associated with periodontal disease in diabetics. The metabolites identified in this study that discriminated the periodontal groups may be useful for developing diagnostics and therapeutics tailored to the diabetic population.

Efficacy of two different toothbrush heads on a sonic power toothbrush compared to a manual toothbrush on established gingivitis and plaque.

OBJECTIVE: To evaluate the efficacy of a power toothbrush with distinct multi-directional cleaning action using two different heads (Colgate ProClinical C200 toothbrush with either a triple clean head or a sensitive head) as compared to a manual flat-trim toothbrush (Oral B Indicator toothbrush) on supragingival plaque and established gingivitis. METHODS: This examiner-blind, randomized, controlled, three-treatment, parallel-group clinical research study assessed plaque removal via the comparison of pre- to post-brushing after a single use and again after four weeks of use, using the Rustogi Modified Navy Plaque Index. This study also assessed gingivitis at four weeks using the Löe-Silness Gingival Index. Qualifying adult male and female subjects from the central New Jersey, USA area reported to the study site after refraining from any oral hygiene procedures for 24 hours, and from eating, drinking, and smoking for four hours. Following an examination for plaque and gingivitis, they were randomized into three balanced groups. Subjects were instructed to brush their teeth for two minutes under supervision with their assigned toothbrush and a commercially available toothpaste (Colgate Cavity Protection toothpaste), after which they were again evaluated for plaque. Subjects were dismissed from the study site with the toothpaste and their assigned toothbrush to use at home twice daily for the next four weeks. They reported to the study site after four weeks of product use, at which time they were evaluated for plaque and gingivitis. RESULTS: One hundred twenty (120) enrolled subjects complied with the protocol and completed the clinical study. The results of the study indicated that all three test products provided statistically significant reductions in pre-brushing to post-brushing plaque scores for whole mouth and interproximal sites after a single use. For gingival margin plaque sites, only the Colgate ProClinical C200 toothbrush, with either the triple clean head or the sensitive head, provided statistically significant reductions in pre- to post-brushing plaque scores. After four weeks of product use, all three test products provided statistically significant reductions in baseline to four-week whole mouth and interproximal site plaque scores, but only the Colgate ProClinical C200 toothbrush, with either the triple clean head or the sensitive head, provided a statistically significant reduction in plaque scores at gingival margin sites. All three test products provided statistically significant reductions in gingival and gingivitis severity index scores after four weeks of product use. Relative to the manual toothbrush group, after a single tooth brushing the Colgate ProClinical C200 toothbrush, with either the triple clean head or sensitive head, provided statistically significantly greater reductions in whole mouth plaque index scores (51.9% and 59.3%, respectively), in gingival margin plaque index scores (700% and 650%, respectively), and interproximal plaque index scores (64.2% and 60.4%, respectively). Relative to the manual toothbrush group, after four weeks of use the Colgate ProClinical C200 toothbrush, with either the triple clean head or sensitive head, provided statistically significantly greater reductions in whole mouth plaque index scores (78.6%, and 82.1%, respectively), in gingival margin plaque index scores (3700% and 3400%, respectively), and interproximal plaque index scores (50.8% and 52.5%, respectively). Relative to the manual toothbrush group, after four weeks of use the Colgate ProClinical C200 toothbrush, with either the triple clean head or sensitive head, provided statistically significantly greater reductions in gingival index scores of 900% and 833%, respectively, and in gingivitis severity index scores of 466.7% and 600%, respectively. All statistically significant reductions were at the p ≤ 0.05 level. There were no statistically significant differences between the scores of the Colgate ProClinical C200 toothbrush with triple clean head and the scores of the Colgate ProClinical C200 toothbrush with sensitive head at any comparison time point. CONCLUSION: The Colgate ProClinicaI C200 toothbrush, with either a triple clean head or a sensitive head, provides statistically significant and clinically relevant levels of efficacy in the removal of supragingival dental plaque in the whole mouth, at the gingival margin, and interproximally after a single tooth brushing and after four weeks of use, as well as a statistically significantly greater level of efficacy in the reduction of gingivitis and gingival bleeding when compared to a manual flat-trim toothbrush.

Efficacy of a desensitizing toothpaste containing arginine and calcium carbonate on dentin surface pore structure and dentin morphology.

PURPOSE: To investigate the laboratory changes in dentin tubule occlusion morphology during short term use of desensitizing products as evaluated by electron microscopy and an image analysis. METHODS: Freshly extracted human third molar teeth were collected at random and 40 dentin discs were prepared. These dentin samples were then divided in to four groups (n=10). The test treatment consisted of undiluted Colgate Sensitive Pro-Relief Toothpaste containing 8.0% arginine and calcium carbonate that was applied on the dentin surface under a brushing cycle of 200 strokes, 2 times/day, for 10 days and then soaked in the filtrated human saliva. The two other test products were a commercial toothpaste, Sensodyne Original, containing 10% strontium chloride and a professional re-mineralizing treatment paste (GC Tooth Mousse). The negative control group was soaked in human saliva that had been sterilized by filtration. The occluding ability of the dentin tubules, using the dentin disc model, was evaluated using scanning electron microscopy (SEM). The degree of occlusion of the dentin tubules was quantified using an image analyzer and the results were analyzed by ANOVA and a Tukey's test. RESULTS: All test products created a smear layer on the dentin surface that significantly reduced the diameter of dentin tubules after treatment. Compared to the dentin tubule area on disks treated with the negative control (72.02 +/- 7.23 microm2), disks treated with Colgate Sensitive Pro-Relief, Sensodyne Original, and GC Mousse had dentin tubule areas of 2.10 +/- 0.42 microm2, 10.11 +/- 2.83 microm2, and 30.40 +/- 4.04 microm2 respectively. These differences were statistically significant.

Clinical evaluation of an in-office desensitizing paste containing 8% arginine and calcium carbonate for relief of dentin hypersensitivity prior to dental prophylaxis.

PURPOSE: To evaluate the clinical efficacy of a professional prophylaxis paste containing 8% arginine-calcium carbonate in the reduction of dentin hypersensitivity used as a pre-procedural application compared to a commercially-available prophylaxis paste. METHODS: This study was conducted at Jersey Shore University Medical Center in Neptune, New Jersey, USA. A mixed population of adult males and females between the ages of 18-70 were included in the study. Baseline air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale) were mandatory for inclusion in this study. Subjects were randomly assigned to either: (1) Control paste, Nupro non-fluoridated pumice based prophylaxis paste (Dentsply Professional) or (2) Test paste, a desensitizing paste containing 8% arginine and calcium carbonate (Colgate-Palmolive Company). Either the Control or Test paste was applied to subjects prior to their receiving a routine dental prophylaxis. After completion of the dental cleaning procedure, a final post-cleaning air blast examination was performed on each subject following identical methods as at the baseline exam. Paired t-tests and ANCOVA were used. RESULTS: 66 subjects were enrolled in the study. Following the post-cleaning air blast hypersensitivity examination, there was a significant decrease of 83.94% in the hypersensitivity of subjects using the Test paste. The group using the Control paste showed a 13.43% desensitization. There was a statistically significant difference of 79.65% between the two groups. Subjects in the age groups 41-50, 51-60, and 61-70 years of age showed the most reduction in dentin hypersensitivity.

Comparative efficacy of a specially engineered sonic powered toothbrush with unique sensing and control technologies to two commercially available power toothbrushes on established plaque and gingivitis.

OBJECTIVE: To evaluate the efficacy on plaque and established gingivitis of a new specially engineered sonic powered toothbrush with unique sensing and control technologies as compared to two commercially available power toothbrushes. METHODS: This examiner-blind, three-treatment, parallel clinical study assessed plaque reduction via the comparison of pre- to postbrushing after a single use, and following four weeks' use measured by the Rustogi Modification of the Modified Navy Plaque Index. This study also assessed gingivitis using the Löe and Silness Gingival Index after four weeks' use. Qualifying adult male and female subjects from the northern New Jersey area reported to the study site after refraining from all oral hygiene procedures for 24 hours, and from eating, drinking, or smoking for four hours. Following an examination for gingivitis and plaque (pre-brushing), they were randomized into three balanced groups, each group using one of the three study toothbrushes in the order specified by a predetermined randomization plan. Subjects were instructed to brush their teeth for two minutes under supervision with their assigned toothbrush according to the manufacturers' instructions and a commercially available toothpaste (Colgate Cavity Protection), after which they were once again evaluated for plaque (post-brushing). Subjects were then dismissed from the study site with the toothpaste and their assigned toothbrush to use at home twice daily for the next four weeks. They again reported to the study site at which time they were evaluated for plaque and gingivitis. RESULTS: One-hundred eighty-four subjects complied with the protocol and completed the clinical study. Relative to the two commercially available toothbrushes, the new specially engineered sonic powered toothbrush with unique sensing and control technologies provided statistically significantly (p < 0.05) greater reductions in whole mouth plaque index scores (21.9 and 25.8%, respectively), gingival margin plaque index scores (14.5% and 18.9%, respectively), interproximal plaque index scores (160.0% and 136.4%, respectively), facial plaque index scores (17.9% for both), lingual plaque index scores (29.2% for both), and interproximal lingual plaque index scores (200.0% and 350.0%, respectively) after a single tooth brushing. Relative to the two commercially available toothbrushes, the new sonic powered toothbrush also provided statistically significantly (p < 0.05) greater reductions in whole mouth plaque index scores (47.4% and 40.0%, respectively), gingival margin plaque index scores (46.2% and 40.7%, respectively), interproximal plaque index scores (650% and 1400%, respectively), facial plaque index scores (47.6% and 40.9%, respectively), lingual plaque index scores (47.1% and 31.6%, respectively), and interproximal lingual plaque index scores (350.0% and 500.0%, respectively) after four weeks. There was no statistically significant (p > 0.05) difference between the two commercially available toothbrushes for any plaque index score comparison. Relative to one of the commercially available toothbrushes, the new sonic powered toothbrush provided statistically significant reductions (p < 0.05) in gingival index scores (25.0%) and gingivitis severity scores (33.3%) after four weeks of product use. There were no statistically significant (p > 0.05) differences in gingivitis or gingivitis severity index scores between the new sonic powered toothbrush and the other commercially available toothbrush. CONCLUSION: A new specially engineered sonic powered toothbrush with unique sensing and control technologies provides significantly greater levels of efficacy on the removal of dental plaque after a single tooth brushing and after four weeks' use when compared to two commercially available power toothbrushes. The new sonic powered toothbrush also provides significantly greater levels of efficacy on the reduction of gingivitis and gingival bleeding when compared to one of the commercially available power toothbrushes.