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Trial record 2 of 51 for:    diabetes periodontitis

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

This study has been completed.
Sponsor:
Collaborator:
Mansoura University
Information provided by (Responsible Party):
Mohamed Anees, Mansoura University
ClinicalTrials.gov Identifier:
NCT02794506
First received: May 29, 2016
Last updated: June 8, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Periodontitis
Drug: Propolis
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Propolis Improves Periodontal Status and Glycemic Control in Subjects With Type 2 Diabetes Mellitus and Chronic Periodontitis: a Randomized Clinical Trial

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • Change of glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: Yes ]
    HbA1c was evaluated at baseline,3 and 6 months


Secondary Outcome Measures:
  • Change of pocket depth [ Time Frame: From baseline and 6 months ] [ Designated as safety issue: Yes ]
  • Change of clinical attachment level [ Time Frame: From baseline and 6 months ] [ Designated as safety issue: Yes ]
  • Change of fasting plasma glucose level [ Time Frame: From baseline and 6 months ] [ Designated as safety issue: Yes ]
  • Change of serum N- epsilon (carboxymethyl) lysine level [ Time Frame: From baseline and 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: June 2014
Study Completion Date: March 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propolis
400 mg oral proplois (capsule) was given to participants once daily for 6 months after performing scaling and root planing.
Drug: Propolis
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.
Drug: Placebo
Placebo capsules was taken by the control group for 6 months after receiving scaling and root planing (SRP).
Other Name: Starch capsules

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   38 Years to 63 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02794506

Locations
Egypt
Faculty of Dentistry
Mansoura, Dakahlia, Egypt
Sponsors and Collaborators
Mohamed Anees
Mansoura University
Investigators
Study Director: Hesham M. El-Sharkawy, Ass.Prof. Mansoura University
  More Information

Publications:

Responsible Party: Mohamed Anees, Lecturer of Oral Medicine and Periodontology, Mansoura University
ClinicalTrials.gov Identifier: NCT02794506     History of Changes
Other Study ID Numbers: DENT-1971 
Study First Received: May 29, 2016
Last Updated: June 8, 2016
Health Authority: Egypt: Ministry of Higher Education
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by Mansoura University:
Diabetes mellitus
Chronic periodontitis
Propolis

Additional relevant MeSH terms:
Diabetes Mellitus
Periodontitis
Chronic Periodontitis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Propolis
Anti-Infective Agents

ClinicalTrials.gov processed this record on December 07, 2016