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

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ClinicalTrials.gov Identifier: NCT02192060
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Rui Vicente Oppermann, Federal University of Rio Grande do Sul

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).

Condition or disease Intervention/treatment Phase
Dental Plaque Other: Test - Using of a suspension containing Triclosan Other: Control - Using of a suspension without Triclosan Not Applicable

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  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of a Triclosan Formulation to Control the Initial Subgingival Biofilm Formation
Study Start Date : May 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Triclosan

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.




Primary Outcome Measures :
  1. Presence of Plaque Free Zone [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192060


Locations
Brazil
Dentistry Faculty, Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Investigators
Principal Investigator: Rui V. Oppermann, DDS, PhD Federal University of Rio Grande do Sul

Responsible Party: Rui Vicente Oppermann, DDS, PhD, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT02192060     History of Changes
Other Study ID Numbers: RVOppermann01
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014

Keywords provided by Rui Vicente Oppermann, Federal University of Rio Grande do Sul:
Biofilm
Triclosan
Crossover
Clinical trial

Additional relevant MeSH terms:
Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Triclosan
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents