NCT02656251

Efficacy of Two Chlorhexidine Solutions to Control the Initial Subgingival Biofilm Formation

Efficacy of Two Clorhexidine Formulations to Control the Initial Subgingival Biofilm Formation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Federal University of Rio Grande do Sul · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Plaque

Interventions

Type	Name	Description
DRUG	0.12% Clorhexidine with alcohol	Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days
DRUG	placebo	Use of placebo every 12 hours for 04 days
DRUG	0.12% Clorhexidine without alcohol	Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2016-01-14
• Last updated: 2016-01-14

Locations

1 site across 1 country: Brazil