Impact of probiotic supplementation in Adjunct with Non-surgical periodontal Therapy on Periodontal and antioxidant status in periodontal patients with type 2 diabetes mellitus
Determination the Effect of Probiotic Supplementation in adjunct with Non-surgical Periodontal Therapy on Periodontal and Antioxidant Status in Type 2 Diabetic Patients with Periodontal Disease
Design
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 Total antioxidant capacity, blood levels of malondialdehyde, superoxide dismutase and glutathione peroxidase enzymes activity; periodontal indices (bleeding index, pocket depth, plaque index and clinical attachment loss) and a 3 days dietary record are evaluated pre and post intervention.
Settings and conduct
fifty patients with T2DM were recruited for this study from the endocrinology clinic of golestan Hospital in Ahwaz, Iran. Then, patient with inclusion criteria and some symptoms of periodontal disease were referred to Dental Clinic for further diagnosis.
Participants/Inclusion and 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; 30 < BMI ≥ 18.5 kg/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
Intervention groups
The intervention group receive probiotic supplement (500 mg as capsulated) for 8 weeks.
the control group receive placebo capsules containing wheat flour (500 mg) for 8 weeks.
Main outcome variables
Total antioxidant capacity; blood levels of malondialdehyde; superoxide dismutase activity; glutathione peroxidase activity; bleeding index; pocket depth; plaque index; clinical attachment loss
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20161104030694N2
Registration date:2018-01-15, 1396/10/25
Registration timing:registered_while_recruiting
Last update:2018-01-15, 1396/10/25
Update count:0
Registration date
2018-01-15, 1396/10/25
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
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
2017-10-23, 1396/08/01
Actual recruitment end date
2018-03-21, 1397/01/01
Trial completion date
empty
Scientific title
Impact of probiotic supplementation in Adjunct with Non-surgical periodontal Therapy on Periodontal and antioxidant status 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
18.5 ≤ BMI < 30
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
Participant
Investigator
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
47
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by using closed bags
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the supplement and placebo were produced by zist takhmir company in the same packages. All packets have code that participants, investigators, and data analyzer were unaware of which package is probiotic supplement and which one is a placebo.
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
Province
Khouzestan
Postal code
61357-15794
Approval date
2017-07-18, 1396/04/27
Ethics committee reference number
ir.ajums.NRC.1396.9612
Health conditions studied
1
Description of health condition studied
Impact of probiotic supplementation on periodontal indices and anti-oxidant status in periodontal patients with type 2 diabetes mellitus
Intervention group: The intervention group receive probiotic supplement (500 mg as capsulated) for 8 weeks.
Category
Other
2
Description
Control group: the control group received one pill/day placebo in the same packing like probiotic supplements that contained the same substance without bacteria.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic of Golestan Hospital
Full name of responsible person
mohsen yarahmadi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 74 3333 1257
Fax
+98 74 3333 1257
Email
yarahmadi14671@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. behzad sharif makhmalzadeh
Street address
Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 74 3333 1257
Fax
+98 74 3333 1257
Email
yarahmadi14671@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Ahmad Zarejavid
Position
Professor of Ahvaz Jundishapur University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 74 3333 1257
Email
yarahmadi14671@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmad Zarejavid
Position
Professor of Ahvaz Jundishapur University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 74 3333 1257
Email
yarahmadi14671@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmad Zarejavid
Position
Professor of Ahvaz Jundishapur University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 74 3333 1257
Email
yarahmadi14671@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the original outcome will be shared.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in academic institutions and businesses
Under which criteria data/document could be used
Any use of data is permitted.
From where data/document is obtainable
Mobile number: 00989170438074
What processes are involved for a request to access data/document
Immediately after the call, the data will be provided to the caller.