- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01943877
Propolis In The Treatment Of Periodontitis (PROPOLIS)
September 16, 2013 updated by: NEHAL N SANGHANI, mds, Rajarajeswari Dental College & Hospital
Propolis In The Treatment Of Chronic Periodontitis - A Clinicomicrobiologic Study
This study was conducted to evaluate by clinical and microbiological parameters the effect of locally delivered propolis as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Materials and Methods: 20 subjects diagnosed with chronic periodontitis were recruited to participate in split-mouth design and provided informed consent.
Subgingival plaque sampling and clinical recording at baseline, 15 days and 1 month was performed.
The patients received scaling and root planing, followed by Propolis administration subgingivally in the test sites.
Significant differences between test and control were evaluated using the Mann-Whitney U test and Wilcoxon rank test.
Study Type
Interventional
Enrollment (Actual)
20
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
-
-
Karnataka
-
Bangalore, Karnataka, India, 560060
- Rajarajeswari Dental College and Hospital
-
-
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
25 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- good general health
- chronic periodontitis
- minimum of 20 natural teeth with at least one pocket per quadrant
- probing depth (PD) between 5 and 8 mm.
Exclusion Criteria:
- subgingival instrumentation within 3 months
- antibiotic therapy within 3 months prior to the start of the study;
- smokers
- pregnant or nursing women
- intolerance or allergy to honey products
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: Propolis
|
scaling root planing
experimental
|
Sham Comparator: scaling and root planing
|
scaling root planing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the probing pocket depth and clinical attachment level
Time Frame: three time points of baseline,2 weeks, 4 weeks
|
three time points of baseline,2 weeks, 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in gingival index and microbiological changes
Time Frame: three time points baseline, 2 weeks, 4 weeks.
|
three time points baseline, 2 weeks, 4 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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
December 1, 2012
Primary Completion (Actual)
August 1, 2013
Study Completion (Anticipated)
October 1, 2013
Study Registration Dates
First Submitted
September 2, 2013
First Submitted That Met QC Criteria
September 16, 2013
First Posted (Estimate)
September 17, 2013
Study Record Updates
Last Update Posted (Estimate)
September 17, 2013
Last Update Submitted That Met QC Criteria
September 16, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 971987
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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