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Propolis In The Treatment Of Periodontitis (PROPOLIS)

Primary Purpose

Chronic Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
scaling root planing
Propolis
Sponsored by
Rajarajeswari Dental College & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rajarajeswari Dental College and Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Propolis

scaling and root planing

Arm Description

Outcomes

Primary Outcome Measures

Change in the probing pocket depth and clinical attachment level

Secondary Outcome Measures

change in gingival index and microbiological changes

Full Information

First Posted
September 2, 2013
Last Updated
September 16, 2013
Sponsor
Rajarajeswari Dental College & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01943877
Brief Title
Propolis In The Treatment Of Periodontitis
Acronym
PROPOLIS
Official Title
Propolis In The Treatment Of Chronic Periodontitis - A Clinicomicrobiologic Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rajarajeswari Dental College & Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propolis
Arm Type
Experimental
Arm Title
scaling and root planing
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
scaling root planing
Intervention Description
scaling root planing
Intervention Type
Drug
Intervention Name(s)
Propolis
Intervention Description
experimental
Primary Outcome Measure Information:
Title
Change in the probing pocket depth and clinical attachment level
Time Frame
three time points of baseline,2 weeks, 4 weeks
Secondary Outcome Measure Information:
Title
change in gingival index and microbiological changes
Time Frame
three time points baseline, 2 weeks, 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Rajarajeswari Dental College and Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560060
Country
India

12. IPD Sharing Statement

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Propolis In The Treatment Of Periodontitis

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