Periodontitis is an infectious disease that associated with cytokine imbalance . Interleukin 18 is a biomarker that has an antioxidant action. Non-surgical treatment is one periodontal treatment method that affects etiologic factors. The aim of this study is investigated salivary Interleukin 18 concentration and its changes following non-surgical treatment in periodontal disease. Inclusion criteria is patient with moderate to severe periodontitis، gingivitis and healthy subjects. Patients with systemic disease will be excluded. Study groups include 25 patients with periodontal disease and 25 healthy subjects selected as controls. Intervention include Scaling and root planing. Unstimulated saliva was collected before and after Scaling and root planing. Changes in the concentrations of this cytokines is expected.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404133795N2
Registration date:2014-06-23, 1393/04/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-23, 1393/04/02
Registrant information
Name
Hojatollah Yousefimanesh
Name of organization / entity
Ahvaz Junishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 0597
Email address
yousefimanesh@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences and Health Services
Expected recruitment start date
2013-04-05, 1392/01/16
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Interleukin 18 levels in saliva of patients with generalized Chronic periodontitis before and after Scaling and root planing
Public title
Evaluation of Interleukin 18 in Chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusin criteria: patients with severe periodontitis; patients with moderate to severe periodontitis; subjects with periodontal healthy
Exclusion criteria: periodontal treatment or antibiotic therapy within the last 3 months; presence of any systemic disease (e.g.,diabetes mellitus, asthma); xerostomia or any other disease of the salivary glands; less than 20 teeth remaining; intake of any drug known to alter salivary rate levels (e.g., for sleeping disorders) or to be immunosuppressive; usage of partial or total prosthesis; pregnancy; lactation; acute infection; immunodeficiency; history of radio- or chemotherapy; and any conditions necessitating antibiotic premedication for dental appointment
Age
From 63 years old to 43 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committe of Ahvaz University of Medical Sciences
Street address
Deputy of development of research and technical sciences of Ahvaz Jundishapur University of Medical Sciences, Golestan
City
Ahvaz
Postal code
61357-15794
Approval date
2013-02-20, 1391/12/02
Ethics committee reference number
ETH-687
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Interleukin 18
Timepoint
At the time of sampling
Method of measurement
ELISA kit
Secondary outcomes
1
Description
Interleukin 18
Timepoint
Six weeks after sampling
Method of measurement
ELISA kit
2
Description
Bleeding on probing
Timepoint
At the time of sampling
Method of measurement
By periodontal probe
Intervention groups
1
Description
The intervention group: Scaling and root planning
Category
Treatment - Other
2
Description
The control group : observation
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontology of Dental facualty of Ahvaz Jondishapoor University of Medical Science
Full name of responsible person
Hossein Didehvari
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences and Health Services
Full name of responsible person
Dr Mostafa Feghhi
Street address
Deputy of development reseach and Technical Development of Ahvaz Jundishapur University of Medical Sciences, University city
City
Ahvaz
Grant name
Grant code / Reference number
U-91237
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapour University of Medical Sciences and Health Services
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental faculty of Ahvaz Jondishapoor University of Medical Science
Full name of responsible person
Mahmood Jahangirnezhad
Position
Associate professor
Other areas of specialty/work
Street address
Department of Periodontology, Dental Faculty, University city
City
Ahvaz
Postal code
Phone
+98 61 1320 5168
Fax
Email
www.mahjahan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental facualty of Ahvaz Jondishapoor University Of Medical Science
Full name of responsible person
Hojjatollah Yoosefimanesh
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Periodontology, Dental Faculty, University city
City
Ahvaz
Postal code
Phone
+98 61 1320 5168
Fax
Email
hoijjatyoosefi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)