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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743548
• Other study ID #: H08-01078
• Status: Completed
• Phase: Phase 3
• First received: August 27, 2008
• Last updated: November 12, 2010
• Start date: August 2008
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults

• Minimum of 4 interproximal areas that can accommodate a minimum 0.6 mm interdental brush width

• Minimum of 8 interproximal bleeding sites upon stimulation

• Dexterity to use manual waxed dental floss

• Able to attend all 4 study visits

Exclusion Criteria:

• Require premedication with antibiotics prior to dental therapy

• Use chlorhexidine or over-the-counter mouthwash during the study

• Smoke

• Have orthodontia

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

Intervention

Device:
• IB = Interdental brush, the intervention
IB is a small multi-tufted brush on a wire attached to a long angled handle that is inserted in a horizontal plane between the teeth. The IB is inserted once and removed.
• DF = Dental floss, the positive control
DF is waxed dental floss; nylon covered with a water soluble unflavoured wax to facilitate easier access the contact points of teeth. DF is rubbed against the interproximal surfaces of the teeth 2-4 times on each surface.

Locations

Country	Name	City	State
Canada	University of British Columbia Nobel Biocare Oral Health Centre	Vancouver	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of British Columbia	British Columbia Dental Hygienists' Association (BCDHA), Canadian Foundation for Dental Hygiene Research and Education, Curaden Swiss

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque and bleeding reduction		12 weeks	No
Secondary	Product preference between dental floss and interdental brush		12 weeks	No