Comparing the Inter-dental Brush to Dental Floss

Gingivitis Clinical Trial

Official title: Comparison of Inter-dental Brush to Dental Floss for Reduction of Plaque and Bleeding in Areas With Intact Papilla: A Clinical Trial

Status Completed

Clinical Trial Summary

The study's purpose is to find an easy and effective alternative to dental floss for those persons who cannot or choose not to dental floss so that they can maintain and/or achieve optimal oral health. The study hypothesis is that the inter-dental brush is as effective as dental floss for removing plaque from between the teeth and for reducing bleeding gums in persons with gingivitis, but may be easier to use and thus encourage daily home use.

Clinical Trial Description

Purpose:

To determine if the interdental brush is just as effective at removing plaque and reducing bleeding gums between the teeth as dental floss.

Rationale:

Many people find dental floss difficult to use and thus, do not floss daily to maintain oral health and prevent gum disease. These individuals may find the interdental brush easier to use and may be motivated to use it daily for optimal oral health.

Study design:

Study subjects will use the dental floss AND the interdental brush for 12 weeks. Plaque and bleeding scores will be measured before the study begins (week 0), mid-way (week 6), and at the end of the 12 weeks. All study subjects receive a teeth cleaning prior to the first measurements and oral hygiene instructions on how to floss and use the interdental brush. Subjects will also answer 4 short questions about their product preference and ease of use.

Study subjects:

32 healthy adult volunteers with bleeding gums. To be included in the study, subjects require 8 bleeding sites, 4 areas that can accommodate the interdental brush, dexterity to dental floss, and willingness to come for 4 study visits. Exclusion criteria include smokers because this can affect the bleeding scores; individuals with braces (orthodontia) which affects plaque levels; individuals using chlorhexidine which is a prescription strength mouthwash used to treat moderate to severe gum disease; pregnant women; and those individuals requiring antibiotics prior to dental appointments. Enrolled study subjects receive a teeth cleaning (value $180), $75 for completing the study, and all study related supplies. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gingivitis

• NCT number: NCT00743548
• Study type: Interventional
• Source: University of British Columbia
• Status: Completed
• Phase: Phase 3
• Start date: August 2008
• Completion date: November 2010