Efficacy of a Triclosan Formulation to Control the Initial Subgingival Biofilm Formation
Primary Purpose
Dental Plaque
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Test - Using of a suspension containing Triclosan
Control - Using of a suspension without Triclosan
Sponsored by
About this trial
This is an interventional prevention trial for Dental Plaque focused on measuring Biofilm, Triclosan, Crossover, Clinical trial
Eligibility 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.
Sites / Locations
- Dentistry Faculty, Federal University of Rio Grande do Sul
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Test
Control
Arm Description
Using of a suspension containing Triclosan
Using of a suspension without Triclosan or other active ingredient
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02192060
First Posted
November 13, 2013
Last Updated
July 14, 2014
Sponsor
Federal University of Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT02192060
Brief Title
Efficacy of a Triclosan Formulation to Control the Initial Subgingival Biofilm Formation
Official Title
Efficacy of a Triclosan Formulation to Control the Initial Subgingival Biofilm Formation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
Keywords
Biofilm, Triclosan, Crossover, Clinical trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test
Arm Type
Experimental
Arm Description
Using of a suspension containing Triclosan
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Using of a suspension without Triclosan or other active ingredient
Intervention Type
Other
Intervention Name(s)
Test - Using of a suspension containing Triclosan
Intervention Description
The participants should have used only the suspension containing Triclosan during 5 days and have stopped with their biofilm control homemade procedures.
Intervention Type
Other
Intervention Name(s)
Control - Using of a suspension without Triclosan
Intervention Description
The participants should have used only the Placebo suspension during 5 days and have stopped with their biofilm control homemade procedures.
Primary Outcome Measure Information:
Title
Presence of Plaque Free Zone
Description
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).
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui V. Oppermann, DDS, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dentistry Faculty, Federal University of Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-003
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Efficacy of a Triclosan Formulation to Control the Initial Subgingival Biofilm Formation
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