A Phase 3 interventional study of IB = Interdental brush, the intervention and DF = Dental floss, the positive control in Gingivitis, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-11-16.
Sponsored by University of British Columbia · Phase 3, Interventional, and Prevention
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.
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.
590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.
This study's planned enrollment of 32 is below the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →University of British Columbia is the lead sponsor of 1,310 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
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
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
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 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.
Plaque and bleeding reduction
Time frame: 12 weeks
Product preference between dental floss and interdental brush
Time frame: 12 weeks
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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University of British Columbia