Effects of Non-Surgical Treatment on Interleukin-17 and Interleukin-23 level in
Gingival Crevicular Fluid in patients with chronic and aggressive periodontitis
Determination of the initial values of the two cytokines
Determination of the amounts of these two cytokines after treatment
Design
clinical trial,
Non randomized sampling,
sample size was calculated based on similar studies: 18 individuals in aggressive group and 18 individuals in chronic group.
Settings and conduct
The study participants will be selected from individuals affected by periodontitis, referred to the Department of Periodontics, Faculty of Dentistry, Shahed University, Tehran, Iran.
Gingival Crevicular Fluid will be harvested before and after initial phase of periodontal treatment. Cytokine concentration will be assessed by ELISA test.
Participants/Inclusion and exclusion criteria
inclusion criteria: individuals with chronic and aggressive periodontitis
exclusion criteria:periodontal treatment within the previous six months, use of any antibiotics /or immunosuppressive drugs in the past 3 months, history of any systemic disease, smoking.
Intervention groups
Control group is the same individuals before scaling and root-planning therapy.
scaling and root-planning therapy will be done for all participant.
Main outcome variables
interleukin-17 level and interleukin-23 levels in chronic and aggressive periodontitis; The effect of phase I periodontal therapy on the level of interleukin-17 and interleukin-23
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180729040623N1
Registration date:2018-08-16, 1397/05/25
Registration timing:retrospective
Last update:2018-08-16, 1397/05/25
Update count:0
Registration date
2018-08-16, 1397/05/25
Registrant information
Name
Fereshteh Shanei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 9210
Email address
fr.shanei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-10-01, 1392/07/09
Expected recruitment end date
2014-10-22, 1393/07/30
Actual recruitment start date
2013-10-01, 1392/07/09
Actual recruitment end date
2014-12-01, 1393/09/10
Trial completion date
empty
Scientific title
Effects of Non-Surgical Treatment on Interleukin-17 and Interleukin-23 level in Gingival Crevicular Fluid in patients with periodontitis
Public title
effect of periodontal treatment on IL-17 and IL-23
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
systematically healthy individuals with chronic or aggressive periodontitis
Exclusion criteria:
history of periodontal treatment within the previous six months, ,
use of any antibiotics /or immunosuppressive drugs in the past 3 months
consumption of any kind of medicine which affects periodontium (including medicine which cause gingival enlargement).
pregnancy
smoking
any immunosuppressive,metabolic or systemic disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Actual sample size reached:
54
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Clinical Ethics Committee of Shahed University
Street address
around the shrine of Imam Khomeini, Persian Gulf,Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2015-05-29, 1394/03/08
Ethics committee reference number
IR.Shahed.REC.1394.297
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
2
Description of health condition studied
Aggressive periodontitis
ICD-10 code
K05.2
ICD-10 code description
Aggressive periodontitis
Primary outcomes
1
Description
Interleukin-17 level
Timepoint
before scaling and root-planning and 6 weeks after intervention
Method of measurement
ELISA test
2
Description
Interleukin-23 level
Timepoint
before scaling and root-planning and 6 weeks after intervention
Method of measurement
ELISA test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All subjects participating in the study are subject to scaling and root-planning treatment, The same people are in control group before the intervention. So there is only one intervention group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental branch of Shahed university
Full name of responsible person
Ferial Taleghani
Street address
N0. 39, Italy St,Vesal St, District 6, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 8895 9210
Email
fr.perio@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Seyed mohammad reza Hakimaneh
Street address
N0. 39, Italy St,Vesal St, District 6, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 8895 9210
Email
fr.shanei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Fereshteh Shanei
Position
Resident
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Tehran Province, Tehran, District 6, Italy St
City
Tehran
Province
Tehran
Postal code
1653648464
Phone
+98 21 8895 9210
Fax
Email
fr.shanei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Fereshteh Shanei
Position
Resident
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Tehran Province, Tehran, District 6, Italy St
City
Tehran
Province
Tehran
Postal code
1653648464
Phone
+98 21 8895 9210
Fax
Email
fr.shanei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Fereshteh Shanei
Position
Resident
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Tehran Province, Tehran, District 6, Italy St
City
Tehran
Province
Tehran
Postal code
1653648464
Phone
+98 21 8895 9210
Fax
Email
fr.shanei@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