Flossing With Chlorhexidine
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.
Procedure: Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effects of Flossing With a Chlorhexidine Solution on Interproximal Gingivitis: a Randomized Controlled Trial|
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
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.
- 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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471783
|Canada, British Columbia|
|Dr. Ian Low|
|2031 West 41st Avenue, Vancouver, British Columbia, Canada|
|Principal Investigator:||Donald Brunette, Ph.D||University of British Columbia|