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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	IRCT
Last refreshed on:	22 February 2018
Main ID:	IRCT2016110430694N1
Date of registration:	2017-01-28
Prospective Registration:	No
Primary sponsor:	Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Public title:	Impact of probiotic supplementation in treatment of periodontal patients with type 2 diabetes mellitus
Scientific title:	Impact of probiotic supplementation on periodontal indices, lipid profile, inflammatory markers and Glycemic Control in periodontal patients with type 2 diabetes mellitus
Date of first enrolment:	2016-11-15
Target sample size:	50
Recruitment status:	Complete
URL:	http://en.irct.ir/trial/24309
Study type:	interventional
Study design:	Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Randomization by using closed bags.
Phase:	2

Countries of recruitment
Iran (Islamic Republic of)

Contacts

Name:	Dr. Ahmad Zarejavid
Address:	Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran Ahvaz Iran (Islamic Republic of)
Telephone:	+98 74 3333 1257
Email:	yarahmadi14671@gmail.com
Affiliation:	Ahvaz Jundishapur University of Medical Sciences

Name:	mohsen yarahmadi
Address:	Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran Ahvaz Iran (Islamic Republic of)
Telephone:	+98 74 3333 1257
Email:	yarahmadi14671@gmail.com
Affiliation:	Ahvaz Jundishapur University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion 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
Exclusion criteria:

Age minimum: 30 years
Age maximum: 60 years
Gender: Both

Health Condition(s) or Problem(s) studied

E11, K04.5

Non-insulin-dependent diabetes mellitus, Chronic periodontitis

Impact of probiotic supplementation on periodontal indices, lipid profile, inflammatory markers and Glycemic Control in periodontal patients with type 2 diabetes mellitus.
Non-insulin-dependent diabetes mellitus, Chronic periodontitis

Intervention(s)

Intervention: The intervention group receive probiotic supplement (500 mg as capsulated) for 8 weeks.

control: the control group receive placebo capsules containing wheat flour (500 mg) for 8 weeks.

Intervention 1: Intervention: The intervention group receive probiotic supplement (500 mg as capsulated) for 8 weeks. Intervention 2: control: the control group receive placebo capsules containing wheat flour (500 mg) for 8 weeks.

Primary Outcome(s)

Bleeding during probe. Timepoint: Immediately Before and after the intervention. Method of measurement: Evaluation of bleeding.

Plaque index. Timepoint: Immediately Before and after the intervention. Method of measurement: Plaque is on the tooth surface.

Fasting blood sugar. Timepoint: Immediately Before and after the intervention. Method of measurement: Using enzymatic kits.

TNF-a. Timepoint: Immediately Before and after the intervention. Method of measurement: Elisa.

Hs-CRP. Timepoint: Immediately Before and after the intervention. Method of measurement: Elisa.

Total cholesterol. Timepoint: Immediately Before and after the intervention. Method of measurement: Using enzymatic kits.

LDL-C. Timepoint: Immediately Before and after the intervention. Method of measurement: Using enzymatic kits.

Clinical attachment level. Timepoint: Immediately Before and after the intervention. Method of measurement: Depth study of cement and enamel plaque periodontal.

IL-6. Timepoint: Immediately Before and after the intervention. Method of measurement: Elisa.

TG. Timepoint: Immediately Before and after the intervention. Method of measurement: Using enzymatic kits.

Hb-A1c. Timepoint: Immediately Before and after the intervention. Method of measurement: Elisa.

HDL-C. Timepoint: Immediately Before and after the intervention. Method of measurement: Using enzymatic kits.

Pocket dept. Timepoint: Immediately Before and after the intervention. Method of measurement: The probing depth is measured by the probe.

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of Ahvaz Joudishapour University of Medical Science

Results

Results available:
Date Posted:
Date Completed:
URL:

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