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Flossing With Chlorhexidine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00471783
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : August 15, 2008
Sponsor:
Collaborators:
Canadian Foundation for Dental Hygiene Research and Education
British Columbia Dental Hygienists' Association (BCDHA)
Information provided by:
University of British Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gingivitis Procedure: Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name. Phase 3

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)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Canada, British Columbia
Dr. Ian Low
2031 West 41st Avenue, Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Canadian Foundation for Dental Hygiene Research and Education
British Columbia Dental Hygienists' Association (BCDHA)
Investigators
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Principal Investigator: Donald Brunette, Ph.D University of British Columbia
More Information
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Responsible Party: Dr. Donald Brunette, University of British Columbia
ClinicalTrials.gov Identifier: NCT00471783    
Other Study ID Numbers: H05-70513
First Posted: May 10, 2007    Key Record Dates
Last Update Posted: August 15, 2008
Last Verified: August 2008
Keywords provided by University of British Columbia:
gingivitis
chlorhexidine
dental floss
 RCT
bleeding on probing
gingival and plaque indices
Additional relevant MeSH terms:
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Gingivitis
Infections
Gingival Diseases
Periodontal Diseases
Mouth Diseases
 Stomatognathic Diseases
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants