Periodontitis is periodontal inflammation that that exceeded and damage to attachment tissues around the teeth. Diabetes is a risk factors in periodontal disease. So far, many studies have shown that there is significant association between periodontitis and types of salivary biomarkers such as MMP-8, IL-1B, CRP, TNFα, IGA .In the present study, will try to compare salivary interleukin-1 beta in diabetic patients with chronic periodontitis and generalized chronic periodontitis and generalized normal blood sugar, review effect of diabetes on the severity of chronic generalized periodontitis. The target population is a patients with chronic generalized periodontitis with diabetes and without diabetes. During the six months, the current study will be, from firs of October 2014 to the end of March in the Tabriz Oral Medicine and Periodontics Department, School of Dentistry. Random sampling would be that will be selected number 56 patients from referred to that center. Inclusion criteria: having the history of type 2 diabetes or people who have more than 2 consecutive blood glucose levels more than 126 mg / dl; the average age of 40-60 years old; having chronic generalized periodontitis that have more than 30% attachment lose; willing to participate in the study. Exclusion criteria: unwillingness to participate in the study; any systemic disease other than diabetes and debilitating diseases that can effect on oral health person's; any non-surgical periodontal therapy that has been done over the last 9 months; smoking or quit smoking less than 5 years; pregnancy or intend to become pregnant during the study period of 6 month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110916246N2
Registration date:2014-11-27, 1393/09/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-27, 1393/09/06
Registrant information
Name
Hossein Eslami
Name of organization / entity
Tabriz University of Medical Sciences, Faculty of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 41 1327 0408
Email address
eslamih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-04-08, 1393/01/19
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of salivary IL-1 beta in moderate to severe chronic generalized periodontitis among healthy subjects and patients with type 2 diabetes
Public title
Comparison of salivary IL-1 beta in moderate to severe chronic generalized periodontitis among healthy subjects and patients with type 2 diabetes
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: having the history of type 2 diabetes or people who have more than 2 consecutive blood glucose levels more than 126 mg / dl; the average age of 40-60 years old; having chronic generalized periodontitis that have more than 30% attachment lose; willing to participate in the study. Exclusion criteria: unwillingness to participate in the study; any systemic disease other than diabetes and debilitating diseases that can effect on oral health person's; any non-surgical periodontal therapy that has been done over the last 9 months; smoking or quit smoking less than 5 years; pregnancy or intend to become pregnant during the study period of 6 month.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Dental and Periodontal Research Cente
Street address
Tabriz University of Medical Sciences
City
tabriz
Postal code
Approval date
2014-11-10, 1393/08/19
Ethics committee reference number
93122
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
IL-1beta
Timepoint
Before intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
generalized chronic periodontitis and chronic periodontitis with diabetes and without diabetes
Timepoint
Before intervention
Method of measurement
PD,CAL, BOP PI, FBS, HbA1c
Intervention groups
1
Description
Saliva was collected in the intervention group and the control group
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Oral Medicine and Periodontics Department
Full name of responsible person
Nazila Sadeghi
Street address
Tabriz University of Medical Sciences, Faculty of Dentistry
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice-chancellor
Full name of responsible person
Dr. Saied Rahimi
Street address
Tabriz Faculty of Dentistry
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice-chancellor
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
Dental and Periodontal Research Center
Full name of responsible person
Dr. Hossein Eslami
Position
Assistant Professor
Other areas of specialty/work
Street address
Tabriz Faculty of Dentistry
City
Tabriz
Postal code
Phone
+98 41 3335 5965
Fax
Email
eslamih@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Oral Medicine
Full name of responsible person
Dr. Hossein Eslami
Position
Assistant professor
Other areas of specialty/work
Street address
Faculty of Dentistry
City
Tabriz
Postal code
Phone
+98 41 3335 5965
Fax
Email
eslamih@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Oral Medicine, Dental School, Tabriz
Full name of responsible person
Dr. Hossein Eslami
Position
Assistant Professor
Other areas of specialty/work
Street address
Tabriz Faculty of Dentistry
City
Tabriz
Postal code
Phone
+98 41 3335 5965
Fax
Email
eslamih@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)