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Completed

NCT Number: NCT00743548

Comparing the Inter-dental Brush to Dental Floss

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.

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Key information

Conditions

Gingivitis Gingival Diseases Gingival Hemorrhage Hemorrhage Infections Mouth Diseases Oral Hemorrhage Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Periodontal Diseases Plaque, Amyloid Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of British Columbia Nobel Biocare Oral Health Centre

Vancouver, British Columbia, V6T 1Z3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IB = Interdental brush, the intervention

Device

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

Device

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.

Primary outcomes

  1. Plaque and bleeding reduction

    Time frame: 12 weeks

Secondary outcomes

  1. Product preference between dental floss and interdental brush

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • British Columbia Dental Hygienists' Association (BCDHA)
  • Canadian Foundation for Dental Hygiene Research and Education
  • Curaden Swiss

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 29, 2008
Registry last updated
Nov 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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