Sunstar Americas, Inc.

To 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.

For 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.

In 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.

Dental 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.

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).

The 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.

One-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.

All 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.

In 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.