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

NCT02192060 | Completed

• 1 other identifier: RVOppermann01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Plaque

Keywords

Biofilm; Triclosan; Crossover; Clinical trial

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Test

EXPERIMENTAL

Using of a suspension containing Triclosan

Other: Test - Using of a suspension containing Triclosan

Control

PLACEBO COMPARATOR

Using of a suspension without Triclosan or other active ingredient

Other: Control - Using of a suspension without Triclosan

Interventions

Test - Using of a suspension containing Triclosan OTHER

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

Test

Control - Using of a suspension without Triclosan OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

Dentistry Faculty, Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

Triclosan

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Rui V. Oppermann, DDS, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: July 16, 2014
• Study Start: May 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

BR (1)