(1) Objectives
Periodontitis is a destructive and progressive inflammatory condition of tooth-supporting tissues, the pathogenesis of which is attributed to several risk factors, including bacteria, the host immune responses and genetics .
The aim of the present study was to evaluate the level and correlation of human S100A12 and IL22 in gingival crevicular fluid(GCF)in patients with chronic periodontitis.
(2) Design : interventional
(3) Setting and conduct:A total of 22 patients ,will be selected from those referring to the Department of Periodontics, Faculty of Dentistry, Shahed University.
After collecting Gingival Crevicular Fluid (GCF) samples from the case group subjects, phase I periodontal treatment will be rendered, which consists of scaling and root planing and oral hygiene control. The subjects are recalled after 4 weeks for collecting samples again. The same areas underwent sampling again to collect GCF samples using the same procedures. The GCF of the patients after and before phase I periodontal treatment , are the case and control groups respectly.
(4) Participants including major eligibility criteria
The inclusion criteria : presence of at least 20 teeth in the oral cavity; affliction with moderate and severe chronic periodontitis with radiographic evidence of bone loss.
The exclusion criteria : patients with cardiovascular diseases and hypertension; use of tobacco; pathologic conditions in the oral cavity; subjects with chronic inflammatory conditions such as rheumatoid arthritis; presence of tumors; pregnancy; use of any medications affecting the periodontium; presence of systemic diseases that affect the course of periodontal disease; having undergone scaling and root planing during the previous 6 months and a history of taking antibiotics and Nonsteroidal anti-inflammatory drug during the previous 3 months.
(5) Intervention:phase I periodontal treatment , which consists of scaling and root planing and oral hygiene control
(6) Main outcome measures (variables): S100A12 ; IL-22
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016123131687N1
Registration date:2017-04-15, 1396/01/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-15, 1396/01/26
Registrant information
Name
Razieh Nejadi
Name of organization / entity
Shahed university, Dental faculty
Country
Iran (Islamic Republic of)
Phone
+98 21 2654 1610
Email address
r.nejadi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-03-10, 1395/12/20
Expected recruitment end date
2017-04-09, 1396/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of phase I periodontal treatment on the concentrations of IL-22 and S100A12 in patients with chronic periodontitis
Public title
The effect of scaling on the concentrations of inflammatory factors in patients with gum diseases
Purpose
Basic scienece
Inclusion/Exclusion criteria
The inclusion criteria : presence of at least 20 teeth in the oral cavity; affliction with moderate and severe chronic periodontitis with radiographic evidence of bone loss
The exclusion criteria : patients with cardiovascular diseases and hypertension; use of tobacco; pathologic conditions in the oral cavity; subjects with chronic inflammatory conditions such as rheumatoid arthritis; presence of tumors; pregnancy; use of any medications affecting the periodontium; presence of systemic diseases that affect the course of periodontal disease; having undergone scaling and root planing during the previous 6 months; history of taking antibiotics and Nonsteroidal anti-inflammatory drug during the previous 3 months
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed university
Street address
Dental faculty of Shahed university,Italia street , between Qods and Vesal street, Tehran
City
Tehran
Postal code
Approval date
2017-02-28, 1395/12/10
Ethics committee reference number
IR.Shahed.REC.1395.219
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
S100A12
Timepoint
base line,4 weeks
Method of measurement
ELISA TEST
2
Description
IL22
Timepoint
base line,4 weeks
Method of measurement
ELISA TEST
Secondary outcomes
1
Description
clinical attachment level
Timepoint
base line, 4 weeks
Method of measurement
by williams probe( clinical)
2
Description
clinical probing depth
Timepoint
base line , 4 weeks
Method of measurement
by williams probe ( clinical)
Intervention groups
1
Description
Intervention :scaling & root planning and oral hygiene control ;
The GCF of the patients after and before phase I periodontal treatment , are the case and control groups respectly.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental faculty of Shahed university
Full name of responsible person
Razieh Nejadi
Street address
Dental faculty of Shahed university,Italia street, between Vesal and Qods, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Dental faculty of Shahed university
Full name of responsible person
Dr.Farid Abbasi
Street address
Dental faculty of Shahed university,Italia street, between Vesal and Qods, Tehran
City
Tehran
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,Dental faculty of Shahed university
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 faculty of Shahed university
Full name of responsible person
Razieh Nejadi
Position
Resident of Periodontics
Other areas of specialty/work
Street address
Dental faculty of Shahed university, Italia street, between Qods and Vesal, Tehran
City
Tehran
Postal code
Phone
+98 21 2654 1610
Fax
Email
dr.nejadi@gmail.com; r.nejadi@shahed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental faculty of Shahed university
Full name of responsible person
Razieh Nejadi
Position
Resident of Periodontics
Other areas of specialty/work
Street address
Dental faculty of Shahed university,Italia street, between Qods and Vesal, Tehran
City
tehran
Postal code
Phone
+98 21 2654 1610
Fax
Email
r.nejadi@shahed.ac.ir; dr.nejadi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental faculty of Shahed university
Full name of responsible person
Razieh Nejadi
Position
Resident of Periodontics
Other areas of specialty/work
Street address
Dental faculty of Shahed university, Italia street, between Vesal and Qods ,Tehran
City
Tehran
Postal code
Phone
+98 21 2654 1610
Fax
Email
dr.nejadi@gmail.com; r.nejadi@shahed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)