Flossing With Chlorhexidine
Primary Purpose
Gingivitis
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name.
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis focused on measuring gingivitis, chlorhexidine, dental floss, RCT, bleeding on probing, gingival and plaque indices
Eligibility Criteria
Inclusion Criteria:
To be considered for inclusion into the study, subjects must fulfill the following conditions:
- 18 years and older
- Have gingivitis (i.e., have pocket depths of 4 mm or less), but not periodontitis
- Willing to floss every day and have the necessary dexterity to floss
- Have a minimum of 20 natural teeth, including 4 molars
- Have at least 10 bleeding sites
- Be a non-smoker
Exclusion Criteria:
Subjects will be excluded from the study, if they have any of the following conditions:
- Pregnant or plan to be pregnant within the next 3 months
- Allergic to chlorhexidine or quinine sulphate
- Require pre-medication with antibiotics for dental treatment
- Currently taking antibiotics
- Currently taking Dilantin, Cyclosporin A, Nifedipine or other calcium channel blockers, aspirin or anti-coagulants
- Currently using chlorhexidine or whitening products
- Have active carious lesions
- Have orthodontic braces
- Have more than 2 crowns or bridges
- Have more than 2 implants
- Have full or partial dentures
- Have periodontitis, i.e., pocket depths of 5 mm or more in more than 2 sites in the mouth
Sites / Locations
- Dr. Ian Low
Outcomes
Primary Outcome Measures
To determine if dental floss presoaked in 0.12% chlorhexidine is more effective at reducing the signs of gingivitis, such as bleeding, than a dental floss in placebo solution of 0.1% quinine sulphate.
Secondary Outcome Measures
Full Information
NCT ID
NCT00471783
First Posted
May 8, 2007
Last Updated
August 13, 2008
Sponsor
University of British Columbia
Collaborators
Canadian Foundation for Dental Hygiene Research and Education, British Columbia Dental Hygienists' Association (BCDHA)
1. Study Identification
Unique Protocol Identification Number
NCT00471783
Brief Title
Flossing With Chlorhexidine
Official Title
The Effects of Flossing With a Chlorhexidine Solution on Interproximal Gingivitis: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (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)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine if flossing with a dental floss presoaked in chlorhexidine, an anti-microbial mouth wash, would improve the clinical signs of gingivitis, an inflammation of the gums characterized by red, swollen, bleeding gums. And to determine if applying chlorhexidine via dental floss would result in tooth staining, which is common with chlorhexidine mouthwashes.
Detailed Description
Purpose of study: To determine if dental floss presoaked in 0.12% chlorhexidine is more effective at reducing the signs of gingivitis, such as bleeding, than a dental floss in placebo solution of 0.1% quinine sulphate.
Trial design: The study will consist of a double-blinded, placebo-controlled parallel three-month clinical trial.
Randomization of subjects into study groups: Subjects randomized with a computer-generated randomization table and balanced block design to make the two groups equal in number of subjects.
Trial schedule:
Screening for potential subjects & consent obtained. Calibration of examiner.
Week -1: Professional prophylaxis consisting of scaling and polishing.
Week 0: Baseline data (GI, SI, PI, BOP, PD) collected on subjects enrolled into the study. OHI - flossing. Subject randomized into a study group.
Week 6: Subjects reassessed for GI, SI, PI, BOP, PD. Compliance check. Replenish floss supply. Subject concerns or questions addressed.
Week 12: Subjects reassessed for GI, SI, PI, BOP, PD. All floss boxes and logbook returned. Subject concerns or questions addressed. Subject exited from study and returned to the care of his or her regular dental professional.
Measurements for data collection (done in this order):
Gingival index (GI) (modification of Löe & Silness, 1963)
Stain Index (SI)
Plaque index (PI) (modification of Silness and Löe, 1964)
Bleeding on Probing (BOP)
Probing Depth (PD)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
gingivitis, chlorhexidine, dental floss, RCT, bleeding on probing, gingival and plaque indices
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name.
Primary Outcome Measure Information:
Title
To determine if dental floss presoaked in 0.12% chlorhexidine is more effective at reducing the signs of gingivitis, such as bleeding, than a dental floss in placebo solution of 0.1% quinine sulphate.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
To be considered for inclusion into the study, subjects must fulfill the following conditions:
18 years and older
Have gingivitis (i.e., have pocket depths of 4 mm or less), but not periodontitis
Willing to floss every day and have the necessary dexterity to floss
Have a minimum of 20 natural teeth, including 4 molars
Have at least 10 bleeding sites
Be a non-smoker
Exclusion Criteria:
Subjects will be excluded from the study, if they have any of the following conditions:
Pregnant or plan to be pregnant within the next 3 months
Allergic to chlorhexidine or quinine sulphate
Require pre-medication with antibiotics for dental treatment
Currently taking antibiotics
Currently taking Dilantin, Cyclosporin A, Nifedipine or other calcium channel blockers, aspirin or anti-coagulants
Currently using chlorhexidine or whitening products
Have active carious lesions
Have orthodontic braces
Have more than 2 crowns or bridges
Have more than 2 implants
Have full or partial dentures
Have periodontitis, i.e., pocket depths of 5 mm or more in more than 2 sites in the mouth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Brunette, Ph.D
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Ian Low
City
2031 West 41st Avenue, Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
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Flossing With Chlorhexidine
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