Propolis In The Treatment Of Periodontitis

Chronic Periodontitis Clinical Trial

— PROPOLIS  

Official title:

Propolis In The Treatment Of Chronic Periodontitis - A Clinicomicrobiologic Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01943877
• Other study ID #: 971987
• Status: Active, not recruiting
• Phase: N/A
• First received: September 2, 2013
• Last updated: September 16, 2013
• Start date: December 2012
• Est. completion date: October 2013

Study information

• Verified date: September 2013
• Source: Rajarajeswari Dental College & Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Procedure:
• scaling root planing
scaling root planing

Drug:
• Propolis
experimental

Locations

Country	Name	City	State
India	Rajarajeswari Dental College and Hospital	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Rajarajeswari Dental College & Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the probing pocket depth and clinical attachment level		three time points of baseline,2 weeks, 4 weeks	No
Secondary	change in gingival index and microbiological changes		three time points baseline, 2 weeks, 4 weeks.	No