In early phase, periodontal parameters including plaque index, pocket depth, clinical attachment loss and bleeding on probing were measured. All participants (study and control groups) received full written and verbal information about the study and signed the informed consent form. Control samples conform the same age and sex with no history of any systemic and periodontal diseases. Five ml non simulatory saliva was collected after scaling. Samples collected in a certain time of the day. Patients should not eat, chew gum and drink fluids except water 1 hour before sampling. Following, patients undergo non surgical treatment and oral hygiene construction. Second salivary samples will be collected and the indices will be evaluated 1 month after scaling. Samples will be kept at temperature -20 C.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016053025649N5
Registration date:2016-06-09, 1395/03/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-09, 1395/03/20
Registrant information
Name
Masoome Eivazi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3822 8397
Email address
m.eivazi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2016-02-04, 1394/11/15
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Non-surgical treatment effect on Salivary Interleukin 6 and Interleukin 17 in patients with chronic periodontitis
Public title
Scaling effect on 2 salivary factors in patients with gingival inflammation
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: good general health with no history of any systemic disease, no history of antibiotic therapy during 2 months before the study begins; no history of NSAID therapy.
Exclusion criteria: smoking or alcohol abuse; patients with mucousal inflammatory lesions such as lichen planus or salivary glands disorders; pregnant or lactating females.
Age
From 18 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Ethics Committee of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
City
Kermanshah
Postal code
Approval date
2016-05-25, 1395/03/05
Ethics committee reference number
KUMS.REC.1395.136
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
IL-6
Timepoint
1 month after scaling
Method of measurement
Mesured by specialized ELISA KIT
2
Description
IL-17
Timepoint
1 month after scaling
Method of measurement
Mesured by specialized ELISA KIT
3
Description
pocket depth
Timepoint
screening day , 1 month after scaling
Method of measurement
Mesuring the distance of pocket base to the gingival margin with periodontal probe
4
Description
clinical attachment loss
Timepoint
screening day , 1 month after scaling
Method of measurement
Mesuring the distance of pocket base to the CEJ. Any changes in this normal amount is defined as clinical attachment loss.
5
Description
plaque index
Timepoint
screening day , 1 month after scaling
Method of measurement
colored surfaces of tooth by disclosing agent
6
Description
bleeding on probing
Timepoint
screening day , 1 month after scaling
Method of measurement
Observe bleeding after probing
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: scaling and root planning
Category
Treatment - Other
2
Description
Control group: collecting saliva samples
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontics, Dentistry School of Kermanshah University of Medical Sciences
Full name of responsible person
Masoome Eivazi
Street address
Dentistry School, Shora Street, Shariati Street
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah Uninersity of Medical Sciences
Full name of responsible person
Kourosh Hamzeei
Street address
Kermanshah Uninersity of Medical Sciences , Shahid Beheshti Blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah Uninersity 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
Kermanshah Dentistry School
Full name of responsible person
Dr. Masoome Eivazi
Position
Assistant professor
Other areas of specialty/work
Street address
Opossite the post office, Shora Street, Shariati Street
City
Kermanshah
Postal code
Phone
+98 83 3722 2400
Fax
Email
m.eivazi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah Dentistry School
Full name of responsible person
Dr. Masoome Eivazi
Position
PhD
Other areas of specialty/work
Street address
Oposite the post office, Shora Street, Shariati Street
City
Kermanshah
Postal code
Phone
+98 83 3722 2400
Fax
Email
m.eivazi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah Dentistry School
Full name of responsible person
Dr. Masoome Eivazi
Position
Assistant professor
Other areas of specialty/work
Street address
Oposite the post office, Shora Street, Shariati Sreet
City
Kermanshah
Postal code
Phone
+98 83 3722 2400
Fax
Email
m.eivazi@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)