Clinical trial NCT00743548: Comparing the Inter-dental Brush to Dental Floss
Official title: Comparison of Inter-dental Brush to Dental Floss for Reduction of Plaque and Bleeding in Areas With Intact Papilla: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingivitis
Keywords: interdental self-care aids
plaque
bleeding gums
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Foundation for Dental Hygiene Research and Education
name: British Columbia Dental Hygienists' Association (BCDHA)
name: Curaden Swiss
First posted: 2008-08-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Plaque and bleeding reduction
timeFrame: 12 weeks
Secondary outcomes:
measure: Product preference between dental floss and interdental brush
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia Nobel Biocare Oral Health Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Pauline Imai, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Penny Hatzimanolakis
role: STUDY_DIRECTOR
References: