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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
Dr. Ian Low
2031 West 41st Avenue, Vancouver, British Columbia, Canada
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.