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

F

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

28 participants in 2 patient groups, including a placebo group

Test
Experimental group
Description:
Using of a suspension containing Triclosan
Treatment:
Other: Test - Using of a suspension containing Triclosan
Control
Placebo Comparator group
Description:
Using of a suspension without Triclosan or other active ingredient
Treatment:
Other: Control - Using of a suspension without Triclosan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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