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

Federal University of Rio Grande do Sul

Status

Completed

Conditions

Dental Plaque

Treatments

Other: Control - Using of a suspension without Triclosan

Other: Test - Using of a suspension containing Triclosan

Study type

Interventional

Funder types

Other

Identifiers

NCT02192060

RVOppermann01

Details and patient eligibility

About

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).

Full description

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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.