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

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).

Study Overview

• Status: Completed
• Conditions: Dental Plaque
• Intervention / Treatment: Other: Test - Using of a suspension containing Triclosan; Other: Control - Using of a suspension without Triclosan

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
      • Dentistry Faculty, Federal University of Rio Grande do Sul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; Using of a suspension containing Triclosan	Other: 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.
Placebo Comparator: Control; Using of a suspension without Triclosan or other active ingredient	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	24 hours

Collaborators and Investigators

• Sponsor: Federal University of Rio Grande do Sul
• Investigators: Principal Investigator: Rui V. Oppermann, DDS, PhD, Federal University of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: November 13, 2013
• First Submitted That Met QC Criteria: July 14, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Estimate): July 16, 2014
• Last Update Submitted That Met QC Criteria: July 14, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Crossover; Biofilm; Clinical trial; Triclosan
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fatty Acid Synthesis Inhibitors; Triclosan
• Other Study ID Numbers: RVOppermann01