Objectives: Evaluation of the impact of a soft toothbrush with tapered-tip (Test Toothbrush) bristles and an ADA reference toothbrush (ADA Toothbrush) on gingival abrasion over a 12-week period.
Methods: This was a randomized, single-center, examiner-blind, two-cell, parallel clinical research study and used the Danser Gingival Abrasion Index to assess the level of gingival abrasion after a single brushing, as well as after six weeks and 12 weeks of twice-daily brushing. Adult male and female subjects from the Central New Jersey, USA area refrained from all oral hygiene procedures for 24 hours. They reported to the study site after refraining from eating, drinking, and smoking for four hours. Following a qualifying examination using plaque and gingivitis scores along with a baseline gingival abrasion examination, subjects were randomized into two balanced groups, each group using one of the two study toothbrushes. Subjects were instructed to brush their teeth for one minute, under supervision, with their assigned toothbrush and a commercially available fluoride toothpaste (Colgate© Cavity Protection Toothpaste), after which they were again evaluated for gingival abrasion. Subjects were dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects were instructed to brush for one minute during each tooth brushing. The subjects reported to the study site after six weeks and 12 weeks of product use, at which time they were evaluated for gingival abrasion.
Results: Seventy-one (71) subjects complied with the protocol and completed the clinical study. The results of this study showed that the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions in gingival abrasion scores as compared to the gingival abrasion scores of the ADA Toothbrush after a single tooth brushing, after six weeks, and after 12 weeks of product use (75.0%, 85.5%, 73.9%, respectively).
Conclusions: The soft toothbrush with tapered-tip bristles produced significantly less gingival abrasion after 12 weeks of product use as compared to the ADA reference toothbrush.
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