Flossing With Chlorhexidine

This study has been completed.
Sponsor:
Collaborators:
Canadian Foundation for Dental Hygiene Research and Education
British Columbia Dental Hygienists' Association (BCDHA)
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00471783
First received: May 8, 2007
Last updated: August 13, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Gingivitis
Procedure: Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name.
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ]

Enrollment: 66
Study Start Date: April 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471783

Locations
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
Principal Investigator: Donald Brunette, Ph.D University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Donald Brunette, University of British Columbia
ClinicalTrials.gov Identifier: NCT00471783     History of Changes
Other Study ID Numbers: H05-70513
Study First Received: May 8, 2007
Last Updated: August 13, 2008
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
gingivitis
chlorhexidine
dental floss
RCT
bleeding on probing
gingival and plaque indices

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on July 26, 2014