Efficacy of Two Chlorhexidine Solutions to Control the Initial Subgingival Biofilm Formation
Primary Purpose
Dental Plaque
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
0.12% Clorhexidine with alcohol
placebo
0.12% Clorhexidine without alcohol
Sponsored by
About this trial
This is an interventional prevention trial for Dental Plaque focused on measuring biofilms, cross over trial, chlorhexidine
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
- University of Rio Grande do Sul
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
0.12% Clorhexidine with alcohol
0.12% Clorhexidine without alcohol
control
Arm Description
0.12% Clorhexidine with alcohol, 15ml every 12 hour for 4 days
0.12% Clorhexidine without alcohol, 15ml every 12 hour for 4 days
placebo 15ml every 12 hour for 4 days
Outcomes
Primary Outcome Measures
Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index.
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
NCT02656251
First Posted
November 18, 2015
Last Updated
January 13, 2016
Sponsor
Federal University of Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT02656251
Brief Title
Efficacy of Two Chlorhexidine Solutions to Control the Initial Subgingival Biofilm Formation
Official Title
Efficacy of Two Clorhexidine Formulations to Control the Initial Subgingival Biofilm Formation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (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 chlorhexidine and alcohol and another one containing clorhexidine with no alcohol 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. 35 volunteers will stop mechanical supragingival 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 a minute a Solution containing chlorhexidine and alcohol or a solution with chlorhexidine alcohol-free or placebo. Every 24h the presence of deposits will be registered with special attention 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
biofilms, cross over trial, chlorhexidine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.12% Clorhexidine with alcohol
Arm Type
Active Comparator
Arm Description
0.12% Clorhexidine with alcohol, 15ml every 12 hour for 4 days
Arm Title
0.12% Clorhexidine without alcohol
Arm Type
Experimental
Arm Description
0.12% Clorhexidine without alcohol, 15ml every 12 hour for 4 days
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
placebo 15ml every 12 hour for 4 days
Intervention Type
Drug
Intervention Name(s)
0.12% Clorhexidine with alcohol
Other Intervention Name(s)
Periogard, No plak
Intervention Description
Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Use of placebo every 12 hours for 04 days
Intervention Type
Drug
Intervention Name(s)
0.12% Clorhexidine without alcohol
Other Intervention Name(s)
Periogard
Intervention Description
Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days
Primary Outcome Measure Information:
Title
Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index.
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
24hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 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
Patricia Weidlich, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Study Director
Facility Information:
Facility Name
University of Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Two Chlorhexidine Solutions to Control the Initial Subgingival Biofilm Formation
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