Evaluation of the effect of nonsurgical treatment of periodontitis on serum level of IL23 ,35 in periodontitis patients with diabetes type II in comparison with the nondiabetic group: a randomized clinical trial
The aim of this study is to determine the effect of non-surgical periodontal treatment on serum levels of IL23 and IL35 in patients with periodontitis and type 2 diabetes compared to non-diabetic patients.
Design
Clinical trial with control group, parallel groups, double blind, non randomized, sample size of 30, including two groups
Settings and conduct
Thirty individuals with periodontitis with or without type 2 diabetes who have had their diabetes for at least one year have been referred to Toba Clinic and Imam Khomeini Hospital in Sari. Patients are randomly assigned into two groups of 15 intervention and control groups: 1. Patients with diabetes and periodontitis. 2. Peridonitis
Participants/Inclusion and exclusion criteria
People with type 2 diabetes and periodontitis older than 18 years old who have a withdrawal criterion. Exit criteria: Patients with advanced renal liver and heart disease and patients treated with drugs that increase insulin resistance and increase blood glucose. Contains prednisolone, cyclosporine, and ... Patients who have taken antibiotics over the past three months. Or undergo periodontal treatment. People with fewer than 14 teeth. Pregnant women, smokers and hemorrhagic diseases, and diabetic patients with uncontrolled blood glucose (8.5 <HBA1C) who need to interfere with increasing their oral doses
Intervention groups
Group One: 15 Patients with Type 2 Diabetes and Periodontitis and Group Two: 15 patients with periodontitis but without diabetes who have criteria for entry into the study are subject to scaling and root planing.
Main outcome variables
IL23
IL35
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171108037325N2
Registration date:2018-02-20, 1396/12/01
Registration timing:prospective
Last update:2018-02-20, 1396/12/01
Update count:0
Registration date
2018-02-20, 1396/12/01
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 816 4722
Email address
maboodi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-24, 1396/12/05
Expected recruitment end date
2018-04-04, 1397/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of nonsurgical treatment of periodontitis on serum level of IL23 ,35 in periodontitis patients with diabetes type II in comparison with the nondiabetic group: a randomized clinical trial
Public title
The effect of scaling and root planning treatment on serum level of IL 23 and IL35 in patients with periodontitis and type 2 diabetes mellitus
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
patient with type 2 diabetes mellitus and periodontitis
Exclusion criteria:
Patients with advanced renal liver and heart failure
Patients treated with drugs that increase insulin resistance and increase blood glucose include prednisolone, cyclosporine, and others.
Patients who have been taking antibiotics for the last three months or have recieved periodontal treatment
Patients with fewer than 14 teeth
Pregnant patients
Smokers
Hemorrhagic diseases
Patients with uncontrolled diabetes mellitus (8.5 <HBA1C) who need to increase their dose of oral medication
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor, methodologist and statistical adviser are not aware of the grouping of patients
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran university of Medical Sciences
Street address
Mazandaran university of Medical Sciences, beginning of Valiasr highway,Three way of Joybar,Imam square,Sari
City
Sari
Province
Mazandaran
Postal code
4816895475
Approval date
2017-08-11, 1396/05/20
Ethics committee reference number
IR.MAZUMS.REC.96.520
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
2
Description of health condition studied
chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
IL23
Timepoint
before intervention/3 months after intervention
Method of measurement
Unit Pg / ml, using Eliza Reader
2
Description
IL35
Timepoint
before intervention/3 months after intervention
Method of measurement
Unit Pg / ml, using Eliza Reader
Secondary outcomes
1
Description
probing depth
Timepoint
befor intervention / 3 months after intervention
Method of measurement
mm unit / periodontal probe
2
Description
clinical attachment loss
Timepoint
before intervention / 3 months after intervention
Method of measurement
mm unit / periodontal probe
3
Description
HBA1c
Timepoint
before intervention/3 months after intervention
Method of measurement
No unit / by spectrophotometer
4
Description
bleeding on probing
Timepoint
before intervention / 3 months after intervention
Method of measurement
no unit/using periodontal probe
5
Description
gingival index
Timepoint
before intervention / 3 months after intervention
Method of measurement
score/by obsevation
6
Description
plaque index
Timepoint
before intervention / 3 months after intervention
Method of measurement
score/by observation
7
Description
Erythrocyte Sedimentation Rate
Timepoint
before intervention / 3 months after intervention
Method of measurement
no unit/sedimentation tube
8
Description
C-Reactive Protein(CRP)
Timepoint
before intervention / 3 months after intervention
Method of measurement
Units / By Nephlometric Method
Intervention groups
1
Description
scaling and root planning
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Touba complex
Full name of responsible person
Dr.Avideh Maboodi
Street address
Sari faculty of dentistry,next to Touba complex,Khazar blvd
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3326 3345
Fax
+98 11 3340 5474
Email
avideh48188@yahoo.com
2
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Dr.Adeleh Bahar
Street address
Razi st.
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
Email
doctor_bahar2000@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Majid Saeedi
Street address
Faculty of Pharmacy,km 20 of Khazar Rd, Peiambare azam educating complex
City
Sari
Province
Mazandaran
Postal code
48175-861
Phone
+98 11 3354 3082
Email
majsaeedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sari university of medical science
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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Avideh Maboudi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Sari Facultu of dentistry,next to Touba complex,Khazar blvd
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3326 3345
Fax
+98 11 3340 5474
Email
maboodi@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Adeleh Bahar
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Touba complex,Khazar blvd
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 2226 1700
Email
doctor_bahar2000@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Aida Eghbalian Nouzanizadeh
Position
dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Sari faculty of dentistry,next to Touba complex, Khazar blvd
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3326 3345
Email
eghbalian73@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
at the end of the work,we just use information for data analysis