Comparing the Inter-dental Brush to Dental Floss
Primary Purpose
Gingivitis
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
IB = Interdental brush, the intervention
DF = Dental floss, the positive control
Sponsored by
About this trial
This is an interventional prevention trial for Gingivitis focused on measuring interdental self-care aids, plaque, bleeding gums
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
Sites / Locations
- University of British Columbia Nobel Biocare Oral Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Plaque and bleeding reduction
Secondary Outcome Measures
Product preference between dental floss and interdental brush
Full Information
NCT ID
NCT00743548
First Posted
August 27, 2008
Last Updated
November 12, 2010
Sponsor
University of British Columbia
Collaborators
Canadian Foundation for Dental Hygiene Research and Education, British Columbia Dental Hygienists' Association (BCDHA), Curaden Swiss
1. Study Identification
Unique Protocol Identification Number
NCT00743548
Brief Title
Comparing the Inter-dental Brush to Dental Floss
Official Title
Comparison of Inter-dental Brush to Dental Floss for Reduction of Plaque and Bleeding in Areas With Intact Papilla: A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Foundation for Dental Hygiene Research and Education, British Columbia Dental Hygienists' Association (BCDHA), Curaden Swiss
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
interdental self-care aids, plaque, bleeding gums
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
IB = Interdental brush, the intervention
Intervention Description
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
Intervention Name(s)
DF = Dental floss, the positive control
Intervention Description
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 Outcome Measure Information:
Title
Plaque and bleeding reduction
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Product preference between dental floss and interdental brush
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline Imai, MSc.
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Penny Hatzimanolakis
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
University of British Columbia Nobel Biocare Oral Health Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
12. IPD Sharing Statement
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Comparing the Inter-dental Brush to Dental Floss
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