- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02126267
Evaluation of Techniques for Scaling and Root Planing and One Stage Full Mouth Disinfection
April 27, 2014 updated by: Douglas Campideli Fonseca, Centro Universitario de Lavras
Clinical and Microbiological Evaluation of Techniques for Scaling and Root Planing Per Quadrant and One Stage Full Mouth Disinfection Associated With Azithromycin or Chlorhexidine: Randomized Controlled Trial
Evaluate and compare the effectiveness in a clinical and microbial perspective one stage full-mouth disinfection technique in relation to scaling and root planing per quadrant associated with chlorhexidine or azithromycin.
Study Overview
Status
Completed
Conditions
Detailed Description
Seventy -seven systemically healthy subjects with chronic periodontitis were randomly included in 6 different predefined groups.
The following periodontal parameters were evaluated: probing depth , clinical attachment level , plaque index, gingival index and percentage of areas affected by periodontal disease.
Microbiologically were evaluated the bacterial load and specific load of five bacterias: The quantification of the bacteria was performed by real-time Polymerase Chain Reaction .
The clinical and microbial baseline evaluations were performed ( periodontal pre- therapy) , 90 and 180 days after treatment.
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Not Applicable
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
-
-
Minas Gerais
-
Lavras, Minas Gerais, Brazil, 37200000
- Douglas Campideli Fonseca
-
-
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 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of slight-moderate chronic periodontitis
Exclusion Criteria:
- Those who were making regular use of antibiotics or anti-inflammatory drugs or had done up to three months before the beginning of the study;
- those who were making regular use (twice a day) of oral rinses with chlorhexidine or essential oils or have made regular use within three months prior to study entry;
- individuals with a history of sensitivity to chlorhexidine or azithromycin;
- subjects undergoing periodontal therapy include dental scaling procedures in the 12 months preceding the start of the study;
- subjects with impaired bifurcation or trifurcation class III;
- who required antibiotic prophylaxis for conducting clinical periodontal examination
- subjects with removable partial dentures and removable or 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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Full mouth disinfection - FMD
n = 10: Procedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days
|
Procedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days
|
Experimental: FMD + chlorhexidine (FMD-CX)
n = 15: Same as FMD with the inclusion of chlorhexidine in office (application of chlorhexidine (CX) (1%) gel in pockets after scaling, brushing tongue for 1 min.
with CX (1%) gel and mouthwash at the beginning and end of each session with CX 0.2% for 30 seconds (with the form of a gargle in the last 10 seconds)).
In addition, use was made of homemade CX 0.2% for 60 days after the scaling in a single phase.
|
Procedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days
application of chlorhexidine (CX) (1%) gel in pockets after scaling, brushing tongue for 1 min.
with CX (1%) gel and mouthwash at the beginning and end of each session with CX 0.2% for 30 seconds (with the form of a gargle in the last 10 seconds)
Home use fo CX 0.2% for 60 consecutive days after the end of the first session of scaling.
|
Experimental: FMD + azithromycin (FMD-AZ)
n = 15: Same as with the FMD include the use of azithromycin (500 mg) once daily for 3 consecutive days.
Medication was started the same day as the end of the scaling.
|
Procedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days
Azithromycin (500 mg) once daily for 3 consecutive days.
|
Experimental: Scaling and root planing (SRP)
(n = 13): scaling procedures were performed per quadrant (30 min.
per quadrant) at weekly intervals between sessions;
|
Scaling procedures were performed per quadrant (30 min.
per quadrant) at weekly intervals between sessions;
|
Experimental: SRP + azithromycin (SRP-AZ)
n = 11: Same as scaling and root planing group (SRP) with inclusion of the use of azithromycin (500 mg) once daily for 3 consecutive days.
Medication was started the same day as the end of the last scaling hemi-arch;
|
Azithromycin (500 mg) once daily for 3 consecutive days.
Scaling procedures were performed per quadrant (30 min.
per quadrant) at weekly intervals between sessions;
|
Experimental: SRP + chlorhexidine (SRP-CX)
n = 13 : Same as group scaling and root planing (SRP) with the inclusion of home use of CX 0.2% for 60 consecutive days after the end of the first session of scaling
|
Home use fo CX 0.2% for 60 consecutive days after the end of the first session of scaling.
Scaling procedures were performed per quadrant (30 min.
per quadrant) at weekly intervals between sessions;
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in clinical attachment
Time Frame: Baseline and 180 days after treatment
|
In this parameter we will evaluate the distance from the cement-enamel junction to the bottom of the periodontal pocket or gingival sulcus.
This measurement is made with a periodontal probe graduated in millimeters
|
Baseline and 180 days after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in probing depth
Time Frame: Baseline and 180 days after treatment
|
In this parameter we will evaluate the distance between the gingival margin and the bottom of the periodontal pocket or gingival sulcus.
This measurement is made with a periodontal probe graduated in millimeters
|
Baseline and 180 days after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Douglas C Fonseca, Ms, Universitary Center of Lavras
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
April 21, 2014
First Submitted That Met QC Criteria
April 27, 2014
First Posted (Estimate)
April 29, 2014
Study Record Updates
Last Update Posted (Estimate)
April 29, 2014
Last Update Submitted That Met QC Criteria
April 27, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07172212.3.0000.5149
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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