Comparing the Inter-dental Brush to Dental Floss

This study has been completed.
Sponsor:
Collaborators:
Canadian Foundation for Dental Hygiene Research and Education
British Columbia Dental Hygienists' Association (BCDHA)
Curaden Swiss
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00743548
First received: August 27, 2008
Last updated: November 12, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Gingivitis
Device: IB = Interdental brush, the intervention
Device: DF = Dental floss, the positive control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Comparison of Inter-dental Brush to Dental Floss for Reduction of Plaque and Bleeding in Areas With Intact Papilla: A Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Plaque and bleeding reduction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Product preference between dental floss and interdental brush [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: August 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Interdental brush (IB), the intervention 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.
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.
Placebo Comparator: 2
Dental floss (DF), the positive control, 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.
Device: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743548

Locations
Canada, British Columbia
University of British Columbia Nobel Biocare Oral Health Centre
Vancouver, British Columbia, Canada, V6T 1Z3
Sponsors and Collaborators
University of British Columbia
Canadian Foundation for Dental Hygiene Research and Education
British Columbia Dental Hygienists' Association (BCDHA)
Curaden Swiss
Investigators
Principal Investigator: Pauline Imai, MSc. University of British Columbia
Study Director: Penny Hatzimanolakis University of British Columbia
  More Information

No publications provided

Responsible Party: Pauline Imai, University of British Columbia
ClinicalTrials.gov Identifier: NCT00743548     History of Changes
Other Study ID Numbers: H08-01078
Study First Received: August 27, 2008
Last Updated: November 12, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
interdental self-care aids
plaque
bleeding gums

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 23, 2014