Protocol summary

Study aim
The aim of this study is to evaluate the effects of ginger supplementation in adjunct with non- surgical periodontal therapy on periodontal status, interleukin 6 and some antioxidant parameters in T2DM patients with chronic periodontitis.
Design
In this double-blind, single center clinical trial study, 46 diabetic patients with chronic periodontitis are selected and randomly divided into two intervention (n=23) and control (n=23) groups. Randomization will be done using sealed envelope method.
Settings and conduct
In this double-blinded clinical trial, 96 type 2 diabetes mellitus patients with some symptoms of periodontal disease are recruited from endocrinology and metabolism clinics of Golestan Hospital of Ahvaz Jundishapur University of Medical Science, Iran. Subjects are referred to Dental Clinic for further diagnosis to confirm periodontal disease. coding done by a third person of health care who does not know anything about the research and the researchers and patients does not know about the contents of the packets.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Males and females aged 30 – 60 y؛ type 2 diabetic patients who have been suffering from the disease for at least 5 years؛ have chronic periodontal disease؛ BMI ≥ 18.5 and < 30kg/m2. Exclusion criteria: diabetic patients being under insulin therapy؛ pregnancy؛ breast feeding؛ history of periodontal treatment؛ thyroid disorders.
Intervention groups
In this double-blind clinical trial, 46 diabetic patients with chronic periodontitis are selected and randomly divided into two intervention (n=23) and control (n=23) groups. The intervention group receives four 500 mg ginger tablets per day (1g before lunch, 1g before dinner) for 60 days. Also, the control group receives four 500 mg placebo tablets (containing chickpea flour) per day (1g before lunch, 1g before dinner), for 60 days. The placebo and ginger tablets are produced by Dineh Company, Iran.
Main outcome variables
The serum levels of IL-6; Activity of antioxidant enzymes (SOD؛ CAT؛ GSHPx); Periodontal indices including (Bleeding index؛ Pocket depth؛ Plaque index and Clinical attachment level).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170304032874N2
Registration date: 2018-03-05, 1396/12/14
Registration timing: retrospective

Last update: 2018-03-05, 1396/12/14
Update count: 0
Registration date
2018-03-05, 1396/12/14
Registrant information
Name
Hasan Gholinezhad
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61336754360
Email address
gholinezhad.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2018-06-10, 1397/03/20
Actual recruitment start date
2017-04-03, 1396/01/14
Actual recruitment end date
2017-06-04, 1396/03/14
Trial completion date
empty
Scientific title
Effect of ginger supplementation in adjunct with non-surgical periodontal therapy on periodontal status, serum levels of interleukin 6 and some serum antioxidant markers in type 2 diabetic patients with chronic periodontitis
Public title
Effect of ginger supplementation in treatment of type 2 diabetic patients with chronic periodontitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Males and females aged 30 – 60 year type 2 Diabetic patients who have been suffering from the disease for at least 5 years type 2 Diabetic patients who have chronic periodontal disease BMI ≥ 18.5 and < 30kg/m2
Exclusion criteria:
Diabetic patients being under insulin therapy Pregnancy Breast feeding History of Periodontal treatment Thyroid disorders
Age
From 30 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data and Safety Monitoring Board
Sample size
Target sample size: 46
Actual sample size reached: 46
Randomization (investigator's opinion)
Randomized
Randomization description
46 subjects are randomly divided into two intervention (n=23) and control (n=23) groups by a permuted block procedure
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, coding will be done by a third person of health care who do not know anything about this research, and researchers and patients will not be aware of the contents of the packets.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-01-27, 1396/11/07
Ethics committee reference number
IR.AJUMS.REC.1396.925

Health conditions studied

1

Description of health condition studied
type 2 diabetic patients with chronic periodontitis disorder.
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
IL-6
Timepoint
Before and after the intervention
Method of measurement
Elisa

2

Description
SOD
Timepoint
Before and after the intervention
Method of measurement
Elisa

3

Description
GSHPx
Timepoint
Before and after the intervention
Method of measurement
Elisa

4

Description
CAT
Timepoint
Before and after the intervention
Method of measurement
Elisa

5

Description
Bleeding during probe
Timepoint
Before and after the intervention
Method of measurement
Evaluation of bleeding

6

Description
Plaque index
Timepoint
Before and after the intervention
Method of measurement
Plaque is on the tooth surface

7

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

8

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

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The intervention group receives four 500 mg Ginger tablets per day(1g before lunch, 1g before dinner) for 60 days. the ginger tablets were produced by Dineh Company, Iran
Category
Other

2

Description
Control group: The Control group receives four 500 mg placebo tablets (containing fiour pease) per day (1g before lunch, 1g before dinner), for 60 days. the placebo tablets are produced by Dineh Company, Iran.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic of Golestan Hospital
Full name of responsible person
hasan gholinezhad
Street address
Golestan treatment training center, Golestan street, Ahvaz, Khosetan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Email
hasan.gholinezhad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Email
badavim@yahoo.com
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
Hasan Gholinezhad
Position
MSc student of Nutrition
Latest degree
Bachelor
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 61 3333 3477
Email
hasan.gholinezhad@gmail.com

Person responsible for scientific 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 87433331257
Email
ahmaddjavid@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hasan Gholinezhad
Position
MSc student of Nutrition
Latest degree
Bachelor
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 61 3333 3477
Email
hasan.gholinezhad@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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