Flossing With Chlorhexidine

NCT00471783 | Completed Phase 3

• 1 other identifier: H05-70513
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis

Keywords

gingivitis; chlorhexidine; dental floss; RCT; bleeding on probing; gingival and plaque indices

Outcome Measures

Primary Outcomes (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.

  3 months

Interventions

Chlorhexidine is the generic name of the mouthwash, Peridex is the brand name. PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Foundation for Dental Hygiene Research and Education: collaborator
• British Columbia Dental Hygienists' Association (BCDHA): collaborator

Study Sites (1)

Dr. Ian Low

2031 West 41st Avenue, Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Donald Brunette, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 10, 2007
• Study Start: April 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: August 15, 2008

Record last verified: 2008-08

Locations

CA (1)