Flossing With Chlorhexidine
Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gingivitis
Intervention: Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name. (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s):
Donald Brunette, Ph.D, Principal Investigator, Affiliation: University of British Columbia
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.
Clinical Details
Official title: The Effects of Flossing With a Chlorhexidine Solution on Interproximal Gingivitis: a Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 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.
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:
1. Screening for potential subjects & consent obtained. Calibration of examiner.
2. Week - 1: Professional prophylaxis consisting of scaling and polishing.
3. Week 0: Baseline data (GI, SI, PI, BOP, PD) collected on subjects enrolled into the
study. OHI - flossing. Subject randomized into a study group.
4. Week 6: Subjects reassessed for GI, SI, PI, BOP, PD. Compliance check. Replenish floss
supply. Subject concerns or questions addressed.
5. 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):
1. Gingival index (GI) (modification of Löe & Silness, 1963)
2. Stain Index (SI)
3. Plaque index (PI) (modification of Silness and Löe, 1964)
4. Bleeding on Probing (BOP)
5. Probing Depth (PD)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Dr. Ian Low, 2031 West 41st Avenue, Vancouver, British Columbia, Canada
Additional Information
Starting date: April 2006
Last updated: August 13, 2008
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