Impact of probiotic supplementation on periodontal indices, lipid profile, inflammatory markers and Glycemic Control in periodontal patients with type 2 diabetes mellitus
In this randomized clinical trial, 50 diabetic patients with chronic periodontitis are selected and allocated to two groups involve intervention (n=25) and control (n=25) groups. The intervention group receives probiotic supplement (500 mg as capsulated) and the control group receives placebo capsules containing wheat flour (500 mg) for 8 weeks. Non-surgical periodontal therapy is performed for all patients during this study. Some demographic data including age, sex; anthropometric indices such as weight, height, BMI, waist and hip circumference; biochemical indices including fasting blood glucose, HbA1c, lipid profile, inflammatory markers such as IL-6, hs-CRP and TNF-a; periodontal indices (bleeding index, pocket depth, plaque index and clinical attachment loss) and a 3 days dietary record are evaluated pre and post intervention.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016110430694N1
Registration date:2017-01-28, 1395/11/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-28, 1395/11/09
Registrant information
Name
Mohsen Yarahmadi
Name of organization / entity
Jondishapoor ahvaz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 1257
Email address
yarahmadi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Joudishapour University of Medical Science
Expected recruitment start date
2016-11-15, 1395/08/25
Expected recruitment end date
2017-01-14, 1395/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of probiotic supplementation on periodontal indices, lipid profile, inflammatory markers and Glycemic Control in periodontal patients with type 2 diabetes mellitus
Public title
Impact of probiotic supplementation in treatment of periodontal patients with type 2 diabetes mellitus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Males and females aged (30 – 60 y); type 2 diabetic patients (at least 5 years of diagnosis) with chronic periodontal disease; BMI ≥ 18.5 < 30kg/m2
Exclusion criteria: Diabetic complications such as renal failure; using insulin therapy; pregnancy; breast feeding; traveling greater than 1 weeks; smoking; using any dietary supplements including probiotic and antioxidant supplements; using immunosuppressive medications; history of periodontal therapy; following specific diet; changing usual diet and planning to weight loss
Age
From 30 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization by using closed bags
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Joudishapour University of Medical Science
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street
City
Ahvaz
Postal code
61357-15794
Approval date
2016-11-01, 1395/08/11
Ethics committee reference number
ir.ajums.rec.1395.452
Health conditions studied
1
Description of health condition studied
Impact of probiotic supplementation on periodontal indices, lipid profile, inflammatory markers and Glycemic Control in periodontal patients with type 2 diabetes mellitus