Clinical trial of a novel interdental brush cleaning system

Abstract

Objective: This single-blind, five parallel-arm, four-week randomized clinical trial was designed to compare the efficacy of a 0.05% cetylpyridinium chloride gel-releasing interdental brush (IDB) with standard interproximal cleaning devices for plaque and gingivitis reduction, and decreased frequency in interproximal gingival bleeding.

Methodology: After consenting, participants meeting inclusion criteria brushed their teeth, received a baseline examination and a professional cleaning, and were then block-randomized into five groups, with the plaque level serving as the blocking variable. All five groups performed standard tooth brushing as a background regimen. Three of the groups were respectively assigned to one of three interdental brush regimens, the fourth group was assigned to a standard flossing regimen (positive control), and the fifth group was assigned to a standard tooth brushing only regimen (control). Clinical outcome data were collected at two and four weeks.

Results: Of a total of 162 starting participants, 152 completed the study. There were no baseline differences among the five groups with respect to age, interproximal plaque score, interproximal gingivitis score, or percent of interproximal bleeding on probing. After two and four weeks, the 3 IDB groups exhibited 30-40 percent lower plaque levels than the control (p < 0.05). With respect to interproximal gingival scores, the active agent IDB group exhibited a statistically significant effect after two weeks, and all three IDB groups demonstrated significantly better outcomes after four weeks (p < 0.05). At two and four weeks, the three IDB groups demonstrated a greater reduction in interproximal bleeding points upon probing compared to the two control groups (p < 0.05). The group using the 0.05% cetylpyridinium gel-releasing IDB system did not demonstrate superior clinical results when compared to the two other IDB groups.

Conclusion: When compared to control and positive control interdental cleaning procedures, daily use of IDBs was effective in reducing interproximal plaque and gingivitis scores, as well as interproximal bleeding on probing. The benefits were evident at two weeks, but were more consistent after four weeks. The 0.05% cetylpyridinium gel-releasing IDB system did not appear to confer a consistently independent incremental benefit.