Propolis Improves Glycemic Control in Subjects With Type 2 Diabetes and Chronic Periodontitis

NCT02794506 | Completed Phase 4 DMC

• 1 other identifier: DENT-1971
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Background: 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). Methods: 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.

Conditions

Diabetes Mellitus; Periodontitis

Keywords

Diabetes mellitus; Chronic periodontitis; Propolis

Outcome Measures

Primary Outcomes (1)

• Change of glycosylated hemoglobin (HbA1c)

  HbA1c was evaluated at baseline,3 and 6 months

  Baseline, 3 and 6 months

Secondary Outcomes (4)

• Change of pocket depth

  From baseline and 6 months

• Change of clinical attachment level

  From baseline and 6 months

• Change of fasting plasma glucose level

  From baseline and 6 months

• Change of serum N- epsilon (carboxymethyl) lysine level

  From baseline and 6 months

Study Arms (2)

Propolis

EXPERIMENTAL

400 mg oral proplois (capsule) was given to participants once daily for 6 months after performing scaling and root planing.

Drug: Propolis

Placebo

PLACEBO COMPARATOR

Placebo capsule was given to participants once daily for 6 months after performing scaling and root planing.

Drug: Placebo

Interventions

Propolis DRUG

Propolis capsules was taken by the experimental group for 6 months after receiving scaling and root planing (SRP).

Also known as: BioPropolis

Propolis

Placebo DRUG

Placebo capsules was taken by the control group for 6 months after receiving scaling and root planing (SRP).

Also known as: Starch capsules

Placebo

Eligibility Criteria

• Age: 38 Years - 63 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients had type 2 diabetes mellitus with a minimum of five years duration and had been taking stable doses of oral hypoglycemic drugs and/or insulin for at least 6 months.
• Patients should have chronic periodontitis with probing pocket depth and clinical attachment loss ≥ 5 mm with detectable bleeding on probing in at least one site in each sextant.
• Patients should have a minimum of 20 teeth to be selected.
• All patients were diagnosed to have moderate to severe chronic periodontitis according to Armitage criteria.

You may not qualify if:

• Smokers.
• Recent extended use of antibiotics or non-steroidal anti-inflammatory drugs within the last 3 months.
• Patients who had any periodontal therapy within one year.
• Patients with grade 3 or 4 retinopathy.
• Pregnancy.
• Women using oral contraceptives.

Sponsors & Collaborators

• Mohamed Anees: lead
• Mansoura University: collaborator

Study Sites (1)

Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, Egypt

Location

Related Publications (28)

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MeSH Terms

Conditions

Diabetes Mellitus; Periodontitis; Chronic Periodontitis

Interventions

Propolis; Starch

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures; Glucans; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Hesham M. El-Sharkawy, Ass.Prof.

  Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Oral Medicine and Periodontology

Study Record Dates

• First Submitted: May 29, 2016
• First Posted: June 9, 2016
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: June 9, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)