Comparing the Inter-dental Brush to Dental Floss

NCT00743548 | Completed Phase 3

• 1 other identifier: H08-01078
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis

Keywords

interdental self-care aids; plaque; bleeding gums

Outcome Measures

Primary Outcomes (1)

• Plaque and bleeding reduction

  12 weeks

Secondary Outcomes (1)

• Product preference between dental floss and interdental brush

  12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

PLACEBO COMPARATOR

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

Interventions

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.

1

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Require premedication with antibiotics prior to dental therapy
• Use chlorhexidine or over-the-counter mouthwash during the study
• Smoke
• Have orthodontia

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Foundation for Dental Hygiene Research and Education: collaborator
• British Columbia Dental Hygienists' Association (BCDHA): collaborator
• Curaden Swiss: collaborator

Study Sites (1)

University of British Columbia Nobel Biocare Oral Health Centre

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid; Gingival Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Pauline Imai, MSc.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Penny Hatzimanolakis

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 29, 2008
• Study Start: August 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 16, 2010

Record last verified: 2010-11

Locations

CA (1)