Efficacy of Two Chlorhexidine Solutions to Control the Initial Subgingival Biofilm Formation
- Conditions
- Dental Plaque
- Interventions
- Drug: 0.12% Clorhexidine with alcoholDrug: placeboDrug: 0.12% Clorhexidine without alcohol
- Registration Number
- NCT02656251
- Lead Sponsor
- Federal University of Rio Grande do Sul
- Brief Summary
The aim of the study is to compare the effect of a suspension containing chlorhexidine and alcohol and another one containing clorhexidine with no alcohol in dynamic of the subgingival biofilm formation versus a Placebo suspension. The initial subgingival biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).
- Detailed Description
This is a double blind, cross over, randomized clinical trial. 35 volunteers will stop mechanical supragingival biofilm removal measures for 96h following a complete scaling and polishing of the tooth surfaces. During this period they will be asked to rinse for a minute a Solution containing chlorhexidine and alcohol or a solution with chlorhexidine alcohol-free or placebo. Every 24h the presence of deposits will be registered with special attention to the presence of a plaque free zone between the apical border of the deposits and the gingival margin. Absence of deposits is scored 0, presence of deposits and plaque free zone =1 and presence of deposits and absence of plaque free zone =2 (MALISKA, A. N. et al. Measuring early plaque formation clinically. Oral health preventive dentistry, v. 4, p. 273-278, 2006). The prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated for significance. Sample size was calculated taking the results from the study o MALISKA, AN (2006) as reference.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- age from 18 years;
- non-smokers;
- have good general health;
- present at least 20 natural teeth in the mouth, including the incisors, canines and premolars without restorations, crowns, gingival recession, anatomic defects, gingivitis e/or periodontitis.
-
• positive history of using antibiotic e/or anti-inflammatory drugs in the month previous to the initial consultation;
- positive history of allergies at using Triclosan;
- pregnant or lactating patients;
- patients in use of fixed orthodontic appliance.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 0.12% Clorhexidine with alcohol placebo 0.12% Clorhexidine with alcohol, 15ml every 12 hour for 4 days 0.12% Clorhexidine without alcohol placebo 0.12% Clorhexidine without alcohol, 15ml every 12 hour for 4 days control 0.12% Clorhexidine without alcohol placebo 15ml every 12 hour for 4 days 0.12% Clorhexidine without alcohol 0.12% Clorhexidine without alcohol 0.12% Clorhexidine without alcohol, 15ml every 12 hour for 4 days 0.12% Clorhexidine without alcohol 0.12% Clorhexidine with alcohol 0.12% Clorhexidine without alcohol, 15ml every 12 hour for 4 days 0.12% Clorhexidine with alcohol 0.12% Clorhexidine with alcohol 0.12% Clorhexidine with alcohol, 15ml every 12 hour for 4 days 0.12% Clorhexidine with alcohol 0.12% Clorhexidine without alcohol 0.12% Clorhexidine with alcohol, 15ml every 12 hour for 4 days control 0.12% Clorhexidine with alcohol placebo 15ml every 12 hour for 4 days control placebo placebo 15ml every 12 hour for 4 days
- Primary Outcome Measures
Name Time Method Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index. 24hours The presence of scores 0, 1 or 2 of the index "Plaque Free Zone" will be recorded at baseline and at each 24 hours, during a period of 96 hours (4 days).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Rio Grande do Sul
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil