Efficacy of Two Chlorhexidine Solutions to Control the Initial Subgingival Biofilm Formation
January 13, 2016 updated by: Patricia Weidlich, Federal University of Rio Grande do Sul
Efficacy of Two Clorhexidine Formulations to Control the Initial Subgingival Biofilm Formation
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil
- University of Rio Grande do Sul
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 0.12% Clorhexidine with alcohol
0.12% Clorhexidine with alcohol, 15ml every 12 hour for 4 days
|
Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days
Other Names:
Use of placebo every 12 hours for 04 days
Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days
Other Names:
|
|
Experimental: 0.12% Clorhexidine without alcohol
0.12% Clorhexidine without alcohol, 15ml every 12 hour for 4 days
|
Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days
Other Names:
Use of placebo every 12 hours for 04 days
Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days
Other Names:
|
|
Placebo Comparator: control
placebo 15ml every 12 hour for 4 days
|
Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days
Other Names:
Use of placebo every 12 hours for 04 days
Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index.
Time Frame: 24hours
|
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).
|
24hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Patricia Weidlich, PhD, Federal University of Rio Grande do Sul
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
November 18, 2015
First Submitted That Met QC Criteria
January 13, 2016
First Posted (Estimate)
January 14, 2016
Study Record Updates
Last Update Posted (Estimate)
January 14, 2016
Last Update Submitted That Met QC Criteria
January 13, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- URio Grande
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