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

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

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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