Propolis Improves Glycemic Control in Subjects With Type 2 Diabetes and Chronic Periodontitis
|ClinicalTrials.gov Identifier: NCT02794506|
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : June 9, 2016
Propolis is a natural resin made by bees from various plant sources. Propolis exerts antimicrobial, anti-inflammatory, immunomodulatory, antioxidant, and antidiabetic properties. The purpose of this study was to assess the adjunctive benefit of propolis supplementation in individuals with both chronic periodontitis and type 2 diabetes mellitus (T2DM) receiving scaling and root planing (SRP).
A 6-month randomized blinded clinical trial comparing SRP with placebo (placebo+SRP group, n=26) or combined with a 6- month regimen of 400 mg oral propolis once daily (propolis+SRP group, n=26) was performed in patients with long-standing T2DM and chronic periodontitis. Treatment outcomes included hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), serum N€-(carboxymethyl) lysine (CML) and changes in periodontal parameters.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Periodontitis||Drug: Propolis Drug: Placebo||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Propolis Improves Periodontal Status and Glycemic Control in Subjects With Type 2 Diabetes Mellitus and Chronic Periodontitis: a Randomized Clinical Trial|
|Study Start Date :||June 2014|
|Primary Completion Date :||December 2014|
|Study Completion Date :||March 2015|
400 mg oral proplois (capsule) was given to participants once daily for 6 months after performing scaling and root planing.
Propolis capsules was taken by the experimental group for 6 months after receiving scaling and root planing (SRP).
Other Name: BioPropolis
Placebo Comparator: Placebo
Placebo capsule was given to participants once daily for 6 months after performing scaling and root planing.
Placebo capsules was taken by the control group for 6 months after receiving scaling and root planing (SRP).
Other Name: Starch capsules
- Change of glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline, 3 and 6 months ]HbA1c was evaluated at baseline,3 and 6 months
- Change of pocket depth [ Time Frame: From baseline and 6 months ]
- Change of clinical attachment level [ Time Frame: From baseline and 6 months ]
- Change of fasting plasma glucose level [ Time Frame: From baseline and 6 months ]
- Change of serum N- epsilon (carboxymethyl) lysine level [ Time Frame: From baseline and 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794506
|Faculty of Dentistry|
|Mansoura, Dakahlia, Egypt|
|Study Director:||Hesham M. El-Sharkawy, Ass.Prof.||Mansoura University|