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

Not Applicable

Completed

• Conditions: Dental Plaque
• Interventions: Other: Test - Using of a suspension containing Triclosan; Other: Control - Using of a suspension without Triclosan

• Registration Number: NCT02192060
• Lead Sponsor: Federal University of Rio Grande do Sul

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-11-13
• Status Verified: 2014-07
• Study First Submitted QC: 2014-07-14
• Last Update Submitted: 2014-07-14
• Study First Posted: 2014-07-16
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test	Test - Using of a suspension containing Triclosan	Using of a suspension containing Triclosan
Control	Control - Using of a suspension without Triclosan	Using of a suspension without Triclosan or other active ingredient

Primary Outcome Measures

Name	Time	Method
Presence of Plaque Free Zone	24 hours	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).

Trial Locations

Locations (1)

Dentistry Faculty, Federal University of Rio Grande do Sul; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil