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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Federal University of Rio Grande do Sul

Current Primary Outcome: Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index. [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Federal University of Rio Grande do Sul

Dates:
Date Received: November 18, 2015
Date Started: July 2015
Date Completion:
Last Updated: January 13, 2016
Last Verified: January 2016