The purpose of this cross-over clinical research is to evaluate the cleaning efficacy of toothbrushes tufted with two types of tapered bristles and end rounded bristles in removal of interdental plaque with clinical measurement (Plaque Index) and objective measurement (digitally measured plaque area). This study will demonstrate the influence by a type of processing bristles on removal of interdental plaque and determine an agreement between the different evaluation methods.
This is a randomized evaluator-masked crossover study with 10 subjects. Subjects will be randomly allocated to three test groups. Subjects will use the assigned toothbrush at baseline appointment and two times a day for a week. Plaque Index and plaque area will be assessed before/after one time use at baseline and Day 7. Subjects will be assigned to another toothbrush after one week wash-out period.

Start Date30 Jun 2021

Sponsor / Collaborator

Sunstar Americas, Inc.

NCT04289051 / CompletedNot Applicable

Clinical Evaluation of the Efficacy of an Intra Oral Rinse for Patients With Xerostomia

Xerostomia causes a difficulty in eating, have irritated oral tissues, and a poor quality of life. The new oral rinse was designed to reduce the symptoms and improve the patient's quality of life. The objectives of the clinical study is to evaluate the effectiveness of the oral rinse comparing to the placebo product and the control product in the market.
This is a randomized double-blind placebo controlled crossover study with 39 patients receiving treatment. Patients will be randomly allocated to three treatment groups. Patients will use the assigned oral rinse four times a day for two weeks. Dry mouth symptoms and other endpoints will be assessed subjectively and objectively at baseline and Day 14. Patients will be assigned to another treatment after one week wash-out period.

Start Date19 Aug 2020

Sponsor / Collaborator

Sunstar Americas, Inc.

NCT03213210 / TerminatedNot Applicable

Clinical Efficacy of Easy-graft CLASSIC for the Treatment of Peri-implantitis

Single arm study to evaluate the effectiveness of treatment approach using a new moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in peri-implantitis.

Start Date12 Nov 2018

Sponsor / Collaborator

Sunstar Americas, Inc.

100 Clinical Results associated with Sunstar Americas, Inc.

0 Patents (Medical) associated with Sunstar Americas, Inc.

Literatures (Medical) associated with Sunstar Americas, Inc.

01 Jun 2021·American journal of dentistryQ4 · MEDICINE

Plaque reduction and tensile strength evaluations of three dental floss products.

Q4 · MEDICINE

Article

Author: Gonzalez, L Angel ; Spirgel, Christine C ; Cwik, James ; Yankell, Samuel ; Shi, Xiuren

PURPOSETo compare GUM ButlerWeave Mint waxed floss, Reach Mint waxed floss and Oral-B Glide Pro-Health Original waxed floss for the tensile strength parameters, load and elongation, and for their ability to reduce artificial plaque. Also examined is the potential relationship between the tensile strength physical attributes and floss efficacy.METHODSFor artificial plaque removal, floss products were placed around interproximal surfaces of artificial plaque-covered posterior-shaped teeth extending to a 60° angle. The testing apparatus moved the floss in a vertical direction to the tooth apex at two strokes per second with a 5 mm stroke for 15 seconds at a pressure of 150 g. The artificial plaque substrate was then evaluated for depth of artificial plaque removed (DPR) using a color comparison scale. Two tensile strength assays measuring maximum load and elongation also were conducted; the assays were based on the guidelines of the American Society for Testing and Materials. Twenty cm floss segments were pulled apart using a constant velocity, a load cell of 5 kN and a test speed of 1000 mm/minute until each floss segment broke apart. For each floss segment, the maximum load was measured in pounds and the elongation was measured in millimeters. Results for artificial plaque removal and tensile strength assays were statistically analyzed using the post hoc Tukey test for multiple pairwise comparisons and t-tests, assuming unequal variance, to compare the DPR, load, and elongation means.RESULTSIn the artificial plaque removal assay, the mean DPR for GUM ButlerWeave Mint waxed floss was greater than the mean DPR for Reach Mint Waxed floss and Oral-B Glide Pro Health Original Waxed floss (P< 0.001). The mean DPR for Reach Mint waxed floss was also greater than Oral-B Glide Pro Health Original waxed floss mean DPR (P< 0.005). In the tensile strength load assay, both Oral-B Glide Pro Health Original waxed floss and GUM ButlerWeave Mint waxed floss had statistically higher means than Reach Mint waxed floss (P< 0.001 for each). There was no significant difference between the Oral-B Glide Pro Health and GUM ButlerWeave Mint waxed floss means (P> 0.05). In the elongation assay, the GUM ButlerWeave Mint waxed floss and Reach Mint waxed floss have statistically higher means than Oral-B Glide Pro Health floss (P< 0.001 for each). There was no statistically significant difference between the GUM ButlerWeave Mint waxed floss and Reach Mint waxed floss means (P> 0.05). In these laboratory assays there were no clear relationships, causal or otherwise, between artificial plaque removal and the testing tensile strength evaluations conducted.CLINICAL SIGNIFICANCEDental plaque will result in the development of caries, gingivitis and periodontal disease if not removed regularly. The statistically higher efficacy of GUM ButlerWeave Mint waxed floss in decreasing artificial plaque depth, compared to two commercially available floss products that have demonstrated clinical efficacy in decreasing plaque and gingivitis, indicate that this product also may be effective for the treatment and reduction of plaque and related diseases.

01 May 2016·Journal of Dental ResearchQ2 · MEDICINE

A Randomized Clinical Trial Evaluating rh-FGF-2/β-TCP in Periodontal Defects

Q2 · MEDICINE

Article

Author: Reddy, M.S. ; Scheyer, E.T. ; McClain, P.K. ; Vassilopoulos, P.J. ; Cochran, D.L. ; Takemura, A. ; Giannobile, W.V. ; Genco, R.J. ; Clem, D.S. ; Abou-Arraj, R.V. ; Mills, M.P. ; Schallhorn, R.A. ; Geurs, N.C. ; Oh, T.-J. ; McGuire, M.K.

Biological mediators have been used to enhance periodontal regeneration. The aim of this prospective randomized controlled study was to evaluate the safety and effectiveness of 3 doses of fibroblast growth factor 2 (FGF-2) when combined with a β-tricalcium phosphate (β-TCP) scaffold carrier placed in vertical infrabony periodontal defects in adult patients. In this double-blinded, dose-verification, externally monitored clinical study, 88 patients who required surgical intervention to treat a qualifying infrabony periodontal defect were randomized to 1 of 4 treatment groups—β-TCP alone (control) and 0.1% recombinant human FGF-2 (rh-FGF-2), 0.3% rh-FGF-2, and 0.4% rh-FGF-2 with β-TCP—following scaling and root planing of the tooth prior to a surgical appointment. Flap surgery was performed with EDTA conditioning of the root prior to device implantation. There were no statistically significant differences in patient demographics and baseline characteristics among the 4 treatment groups. When a composite outcome of gain in clinical attachment of 1.5 mm was used with a linear bone growth of 2.5 mm, a dose response pattern detected a plateau in the 0.3% and 0.4% rh-FGF-2/β-TCP groups with significant improvements over control and 0.1% rh-FGF-2/β-TCP groups. The success rate at 6 mo was 71% in the 2 higher-concentration groups, as compared with 45% in the control and lowest treatment groups. Percentage bone fill in the 2 higher-concentration groups was 75% and 71%, compared with 63% and 61% in the control and lowest treatment group. No increases in specific antibody to rh-FGF-2 were detected, and no serious adverse events related to the products were reported. The results from this multicenter trial demonstrated that the treatment of infrabony vertical periodontal defects can be enhanced with the addition of rh-FGF-2/β-TCP ( ClinicalTrials.gov NCT01728844).

01 Jan 2006·The Journal of clinical dentistry

Interproximal gingivitis and plaque reduction by four interdental products.

Article

Author: Mallatt, Mark E ; Yost, Kevin G ; Liebman, Joanne

OBJECTIVEThe study was conducted to compare the performance of three interdental products to dental floss in the control and removal of plaque, and in the reduction of gingivitis.METHODOLOGYOne-hundred and twenty subjects were screened for the presence of interproximal sites of a size suitable for a GUMO Go-Betweens cleaner, and for being in compliance with inclusion and exclusion criteria. They were then assessed with the Plaque, Gingivitis, and Eastman Interdental Bleeding Indices (EIBI) at baseline, given a prophylaxis, randomly assigned to one of four products (Glide dental floss, Butler flossers, GUM Go-Betweens cleaners, and GUM Soft-Picks cleaners), and given product use instructions. Subjects returned at three weeks for a compliance review and at six weeks for a final visit. Plaque was assessed at the final visit before and after using the assigned products. Plaque, gingivitis, and bleeding scores were evaluated by analysis of covariance using the baseline measurements as the covariate.RESULTSAll four interdental products significantly reduced interdental plaque from baseline to before-use at the final visit (after six weeks) employing baseline plaque as a covariate. Reductions were 16% to 24%. Similarly, use of the products at the final visit resulted in 26% to 31% reductions in plaque with the before-use plaque as a covariate. Interdental gingivitis scores showed a reduction both lingually and buccally, with reductions ranging from 27% to 36% for the former and 34% to 53% for the latter (baseline was the covariate). No statistical differences were found between the products on the lingual interdental sites. The Go-Betweens cleaners showed a statistically greater reduction in the Gingival Index score buccally than the other three products. No differences were noted among the products for the EIBI.CONCLUSIONIn this study, dental floss, the recognized "gold standard" for gingivitis reduction, was matched in performance by flossers and an interdental cleaner with small elastomeric fingers, and surpassed by an interdental brush. All products performed comparably for plaque reduction and removal.

100 Deals associated with Sunstar Americas, Inc.

100 Translational Medicine associated with Sunstar Americas, Inc.

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