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

Dental Plaque Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192060
• Other study ID #: RVOppermann01
• Status: Completed
• Phase: N/A
• First received: November 13, 2013
• Last updated: July 14, 2014
• Start date: May 2013
• Est. completion date: June 2013

Study information

• Verified date: July 2014
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Plaque

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Dentistry Faculty, Federal University of Rio Grande do Sul	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No