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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

Tracking Information
First Submitted Date  ICMJE May 8, 2007
First Posted Date  ICMJE May 10, 2007
Last Update Posted Date August 15, 2008
Study Start Date  ICMJE April 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2008)		 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2007)		 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Flossing With Chlorhexidine
Official Title  ICMJE The Effects of Flossing With a Chlorhexidine Solution on Interproximal Gingivitis: a Randomized Controlled Trial
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:

  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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gingivitis
Intervention  ICMJE Procedure: Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2007)		 66
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00471783
Other Study ID Numbers  ICMJE H05-70513
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr. Donald Brunette, University of British Columbia
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University of British Columbia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Canadian Foundation for Dental Hygiene Research and Education
  • British Columbia Dental Hygienists' Association (BCDHA)
Investigators  ICMJE
Principal Investigator: Donald Brunette, Ph.D University of British Columbia
PRS Account University of British Columbia
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP