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Trial record 2 of 59 for:    diabetes periodontitis

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
Sponsor:
Collaborator:
Mansoura University
Information provided by (Responsible Party):
Mohamed Anees, Mansoura University

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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2014
Primary Completion Date : December 2014
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change of glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline, 3 and 6 months ]
    HbA1c was evaluated at baseline,3 and 6 months


Secondary Outcome Measures :
  1. Change of pocket depth [ Time Frame: From baseline and 6 months ]
  2. Change of clinical attachment level [ Time Frame: From baseline and 6 months ]
  3. Change of fasting plasma glucose level [ Time Frame: From baseline and 6 months ]
  4. Change of serum N- epsilon (carboxymethyl) lysine level [ Time Frame: From baseline and 6 months ]


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Ages Eligible for Study:   38 Years to 63 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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


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

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
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Mohamed Anees, 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