Comparing the Inter-dental Brush to Dental Floss

NCT ID: NCT00743548

Last Updated: 2010-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-11-30

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.

Conditions

Gingivitis

Keywords

interdental self-care aids; plaque; bleeding gums

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

IB = Interdental brush, the intervention

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

DF = Dental floss, the positive control

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Foundation for Dental Hygiene Research and Education

OTHER

Sponsor Role: collaborator

British Columbia Dental Hygienists' Association (BCDHA)

INDUSTRY

Sponsor Role: collaborator

Curaden Swiss

INDUSTRY

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

University of British Columbia

Principal Investigators

Pauline Imai, MSc.

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Penny Hatzimanolakis

Role: STUDY_DIRECTOR

University of British Columbia

Locations

University of British Columbia Nobel Biocare Oral Health Centre

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H08-01078

Identifier Type: -

Identifier Source: org_study_id