Efficacy of a Triclosan Formulation to Control the Initial Subgingival Biofilm Formation

N/ACompletedNCT02192060

Federal University of Rio Grande do Sul28 enrolled

Overview

The aim of the study is to compare the effect of a suspension containing Triclosan 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).

This is a double blind, cross over, randomized clinical trial. 28 volunteers will stop mechanical supragingiva 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 one minute with a slurry of either a triclosan containing dentifice or a control without triclosan. Every 24h the presence of deposits will be registered with special atention 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Dental Plaque

Interventions

Test - Using of a suspension containing TriclosanOTHER

The participants should have used only the suspension containing Triclosan during 5 days and have stopped with their biofilm control homemade procedures.

Control - Using of a suspension without TriclosanOTHER

The participants should have used only the Placebo suspension during 5 days and have stopped with their biofilm control homemade procedures.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

Dentistry Faculty, Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

Presence of Plaque Free Zone

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).

Time frame: 24 hours

Data from ClinicalTrials.gov

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