Propolis Improves Glycemic Control in Subjects With Type 2 Diabetes and Chronic Periodontitis
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|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|
|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|
|Actual Primary Completion Date :||December 2014|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|