Flossing With Chlorhexidine
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|ClinicalTrials.gov Identifier: NCT00471783|
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : August 15, 2008
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|Condition or disease||Intervention/treatment||Phase|
|Gingivitis||Procedure: Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name.||Phase 3|
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)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effects of Flossing With a Chlorhexidine Solution on Interproximal Gingivitis: a Randomized Controlled Trial|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
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
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Responsible Party:||Dr. Donald Brunette, University of British Columbia|
|Other Study ID Numbers:||
|First Posted:||May 10, 2007 Key Record Dates|
|Last Update Posted:||August 15, 2008|
|Last Verified:||August 2008|
bleeding on probing
gingival and plaque indices
Anti-Infective Agents, Local