Flossing With Chlorhexidine - Full Text View

Sponsors and Collaborators:	University of British Columbia 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

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 III

Drug Information available for: Chlorhexidine Chlorhexidine digluconate Hibiclens

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Effects of Flossing With a Chlorhexidine Solution on Interproximal Gingivitis: a Randomized Controlled Trial

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:

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)

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

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

Keywords provided by University of British Columbia:

gingivitis
chlorhexidine
dental floss

RCT
bleeding on probing
gingival and plaque indices

Study placed in the following topic categories:

Mouth Diseases
Anti-Infective Agents, Local
Disinfectants
Periodontal Diseases
Chlorhexidine

Gingival Diseases
Gingivitis
Chlorhexidine gluconate
Stomatognathic Diseases
Hemorrhage

Additional relevant MeSH terms:

Mouth Diseases
Anti-Infective Agents
Gingival Diseases
Chlorhexidine
Pharmacologic Actions
Anti-Infective Agents, Local
Periodontal Diseases

Disinfectants
Gingivitis
Chlorhexidine gluconate
Therapeutic Uses
Stomatognathic Diseases
Dermatologic Agents

ClinicalTrials.gov processed this record on May 07, 2009