University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
NCT Number: NCT02656251
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).
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Notify Me18 year–40 year
All sexes
Interventional
Phase 3
Porto Alegre, Rio Grande do Sul, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days
Other names: Periogard, No plak
Use of placebo every 12 hours for 04 days
Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days
Other names: Periogard
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).
Federal University of Rio Grande do Sul
Other
Efficacy of Two Clorhexidine Formulations to Control the Initial Subgingival Biofilm Formation
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