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

NCT ID: NCT02192060

Last Updated: 2014-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-06-30

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.

Conditions

Dental Plaque

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Test

Using of a suspension containing Triclosan

Group Type: EXPERIMENTAL

Test - Using of a suspension containing Triclosan

Intervention Type: OTHER

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 Triclosan or other active ingredient

Group Type: PLACEBO_COMPARATOR

Control - Using of a suspension without Triclosan

Intervention Type: OTHER

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

Interventions

Test - Using of a suspension containing Triclosan

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

Intervention Type: OTHER

Control - Using of a suspension without Triclosan

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Rui Vicente Oppermann

DDS, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rui V. Oppermann, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

Dentistry Faculty, Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

RVOppermann01

Identifier Type: -

Identifier Source: org_study_id