This study is going to investigate the effect of non-surgical treatment on salivary concentration of two proinflammatory mediators, TNF-alpha and IL-1alpha. Thirty subjects with chronic periodontitis and 30 subjects without any periodontal problem, according to inclusion and exclusion criteria, will be selected to participate in this study.
Inclusion criteria: Healthy subjects; having at least 18 years old and more than 20 teeth. Exclusion criteria is pregnancy, lactation, history of antibiotics or NSAIDs intake, presence of inflammatory mucosal lesions, smoking and alcohol abuse. Intervention include Scaling and root planing. Unstimulated saliva will be collected before Scaling and root planing and 30 days after intervantion. Periodontal parameters like pocket depth, clinical attachment loss and bleeding on probing will be recorded and samples will be collected to evaluate periodontal situation and response to treatment. Saliva samples of control group will be collected too. After centrifuging and aliquoting saliva samples they will kept at -20 temperature until ELISA test will be done on samples. Change in the concentrations of TNF-alpha and IL-1alpha is expected.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052825649N3
Registration date:2016-06-07, 1395/03/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-07, 1395/03/18
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
Vice chancellor for research,Kermanshah University of Medical Sciences
Expected recruitment start date
2016-02-09, 1394/11/20
Expected recruitment end date
2016-05-04, 1395/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of IL-1alpha and TNF-alpha levels in saliva of patients with Chronic periodontitis before and after Scaling and Root Planing
Public title
The effect of Scaling and Root Planning on level of TNF-alpha and IL-1alpha of saliva
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Subjects with chronic periodontitis; Subjects with periodonta healthy; being healthy.
Exclusion criteria : Subjects with systemic disorders (e.g.,diabetes mellitus, asthma); Pregnancy and Lactation; Having Less than 20 teeth; Use of antibiotics during last month; History of continuous consumption of NSATDs; Smoking , Alcohol abuse; History of periodontal treatments during one previous year; Subjects with inflammatory mucosal lesions (Lichen Planus) and Salivary gland disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Ethics Committe of Kermanshah University of Medical Sceinces,Shahidbeheshti Blvd
City
Kermanshah
Postal code
Approval date
2016-05-25, 1395/03/05
Ethics committee reference number
KUMS.REC.1395.128
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-1alpha
Timepoint
At the time of scaling and 30 days after it
Method of measurement
ELISA kit
2
Description
Tumor Necrosis Factor alpha
Timepoint
At the time of scaling and 30 days later
Method of measurement
ELISA kit
Secondary outcomes
1
Description
Pocket depth
Timepoint
At the time of scaling and 30 days later
Method of measurement
measuring the distance of pocket base to the gingval margin using periodontal probe
2
Description
Clinical Attachment Loss
Timepoint
At the time of scaling and 30 days later
Method of measurement
measuring the distance of base of the pocket from CEJ
3
Description
Bleeding during Probing
Timepoint
At the time of scaling and 30 days later
Method of measurement
Observation
4
Description
Plaque Index
Timepoint
At the time of scaling and 30 days later
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: Non-Surgical Treatment (Scaling and Root Planning)
Category
Treatment - Other
2
Description
Control group: observation
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontics,Dentistry school, 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
Vice Chancellor for research of Kermanshah University of Medical Sciences
Full name of responsible person
Kourosh Hamzeei
Street address
Ethics Committe of Kermanshah University of Medical Sceinces,Shahidbeheshti Blvd
City
Kermanshah
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 of Kermanshah University 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 Eivaz
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
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
Opossite the post office , Shora street , Shariati stree
City
Kermanshah
Postal code
Phone
00
Fax
Email
m.eivazi@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)