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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02192060

Enrollment

Registered

2014-07-16

Start date

2013-05-31

Completion date

2013-06-30

Last updated

2014-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Plaque

Keywords

Biofilm, Triclosan, Crossover, Clinical trial

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.

Interventions

OTHERTest - 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.

OTHERControl - 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026