Clinical trial NCT00471783: Flossing With Chlorhexidine
Official title: The Effects of Flossing With a Chlorhexidine Solution on Interproximal Gingivitis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingivitis
Keywords: gingivitis
chlorhexidine
dental floss
RCT
bleeding on probing
gingival and plaque indices
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Foundation for Dental Hygiene Research and Education
name: British Columbia Dental Hygienists' Association (BCDHA)
First posted: 2007-05-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: 2031 West 41st Avenue, Vancouver
country: Canada
facility: Dr. Ian Low
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Donald Brunette, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: