Protocol summary

Summary
The purpose of this study is to investigate the effect of melatonin supplement along with non-surgical periodontal therapy on periodontal status, salivary melatonin, glycemic control, inflammatory markers and blood lipid profile in type 2 diabetic patients with chronic periodontitis. In this double-blind, single center clinical trial 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. The intervention group will receive two 3 mg Melatonin tablets per day, one hour before bedtime, for 60 days. The control group will receive two 3 mg placebo tablets (containing cellulose, silicon dioxide and starch) one hour before bedtime, for 60 days. Non-surgical periodontal therapy will be 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 factors, inflammatory markers (IL-6 and hs-CRP), salivary melatonin; periodontal indices (bleeding index, pocket depth, plaque index and clinical attachment level), physical activity and 3-day 24-hour recall are evaluated pre and post intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011631993N1
Registration date: 2017-02-12, 1395/11/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-12, 1395/11/24
Registrant information
Name
Hadi Bazyar
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 1257
Email address
bazyar.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-01-29, 1395/11/10
Expected recruitment end date
2017-05-10, 1396/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin supplement along with non surgical periodontal therapy on periodontal status, salivary melatonin, glycemic control, inflammatory markers and blood lipid profile in type 2 diabetic patients with chronic periodontitis
Public title
The effect of melatonin supplementation in the treatment of type 2 diabetic patients with chronic periodontitis disorder.
Purpose
Supportive
Inclusion/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 and 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;
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: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Sealed pocket

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran Ahvaz
City
Ahvaz
Postal code
61357-15794
Approval date
2017-01-17, 1395/10/28
Ethics committee reference number
IR.AJUMS.REC.1395.685

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
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
Fasting blood sugar
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

3

Description
hs-CRP
Timepoint
Before and after the intervention
Method of measurement
ELISA

4

Description
HbA1C
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

5

Description
HDL.C
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

6

Description
Triglyceride
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

7

Description
LDL.C
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

8

Description
Total cholestrol
Timepoint
Before and after the intervention
Method of measurement
Using enzymatic kit method

9

Description
Salivary malatonin
Timepoint
Before and after the intervention
Method of measurement
ELISA

10

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

11

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

12

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

13

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

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group receives two 3-mg Melatonin tablets per day, 1 hour before bedtime, for 60 days.
Category
Other

2

Description
The control group receives two 3-mg placebo tablets (containing cellulose, silicon dioxide and starch) per day, 1 hour before bedtime, for 60 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic of Golestan Hospital
Full name of responsible person
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hadi Bazyar
Position
Msc Student of Nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
City
Ahvaz
Postal code
Phone
+98 74 3333 1257
Fax
Email
hadibazyar2015@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Ahmad Zarejavid
Position
Professor of Ahvaz Jundishapur University of Medical Sciences
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
City
Ahvaz
Postal code
Phone
+98 74 3333 1257
Fax
Email
ahmaddjavid@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hadi Bazyar
Position
Msc Student of Nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
City
Ahvaz
Postal code
Phone
+98 74 3333 1257
Fax
Email
hadibazyar2015@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
empty
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