Gingivitis
Conditions
Keywords
interdental self-care aids, plaque, bleeding gums
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.
Interventions
DEVICEIB = 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.
DEVICEDF = 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.
Sponsors
Canadian Foundation for Dental Hygiene Research and Education
British Columbia Dental Hygienists' Association (BCDHA)
Curaden Swiss
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plaque and bleeding reduction | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Product preference between dental floss and interdental brush | 12 weeks |
Countries
Canada
Outcome results
None listed