Evaluating the effect of non surgical periodontal treatment on the severity of systemic lupus erythematosus in patients referred to the Department of Rheumatology of Shahid Sadoughi and Rahnemon Hospitals
Determining the effect of non-surgical periodontal treatments on the severity of systemic lupus erythematosus
Design
Clinical trial with control group, single blind, randomized, 90 eligible patients are divided into two groups using a random number table
Settings and conduct
This study will be performed in patients referred to the rheumatology department of Shahid Sadoughi and Rahnemoun hospitals in Yazd, who simultaneously suffer from systemic lupus erythematosus (SLE) and periodontitis. Record the percentage of areas with bleeding during probing and plaque index will be evaluated. Then the severity of SLE activity is recorded by calculating the SLE activity index as well as the laboratory results of acute phase reactive protein (CRP) and erythrocyte sedimentation rate (ESR). In the intervention group, scaling treatment and root surface leveling are performed. After 3 months, the variables in both groups are evaluated as at the beginning of the study, and finally the comparison between the control and experimental groups in terms of this specific index is done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definitive confirmation of systemic lupus erythematosus by a fellow rheumatologist, confirmation of moderate to severe generalized chronic periodontitis, no use of any antibiotics during 3 months before the start of the study. Exclusion criteria: having another systemic disease, history of periodontal treatment in the last 6 months, smoking
Intervention groups
Patients are randomly divided into two groups (intervention group undergoing scaling treatment and health education and control group without periodontal treatment)
Main outcome variables
Probing depth, Clinical attachment loss ,Bleeding index, Plaque index,Systemic lupus erythematosus index and laboratory results of acute phase reactive protein (CRP) and erythrocyte sedimentation rate (ESR)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151013024509N4
Registration date:2021-03-23, 1400/01/03
Registration timing:registered_while_recruiting
Last update:2021-03-23, 1400/01/03
Update count:0
Registration date
2021-03-23, 1400/01/03
Registrant information
Name
Fahimeh Rashidi Maybodi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 519 6227
Email address
f-rashidi63@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of non surgical periodontal treatment on the severity of systemic lupus erythematosus in patients referred to the Department of Rheumatology of Shahid Sadoughi and Rahnemon Hospitals
Public title
Evaluating the effect of non surgical periodontal treatment on the severity of systemic lupus erythematosus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive confirmation of systemic lupus erythematosus by a fellow rheumatologist and the condition of the disease is controlled
Confirmation of moderate to severe generalized chronic periodontitis
Have at least 20 teeth
There is no evidence of heart valve involvement, congenital disorder, or a history of previous endocarditis requiring antibiotic prophylaxis.
The patient's dose of corticosteroids should be below 20 mg of hydrocortisone or its equivalent
A recent blood test is available based on the patient's neutrophil count above 1000
Evaluation of coagulation factors in case of thrombocytopenia in the patient's blood test
Not taking aspirin and anticoagulants in the last month
Do not take any antibiotics for 3 months before the start of the study
Do not take a cytotoxic drug such as cyclophosphamide in the last month
Non-long-term use of drugs affecting periodontal status (anticonvulsants, calcium channel blockers, etc.) during the 3 months before the start of the study
Complete the consent form
Exclusion criteria:
Having another systemic disease such as primary Sjogren's syndrome, diabetes, cardiovascular disease, history of radiation therapy or chemotherapy
Antiphospholipid syndrome
Pregnancy in a recent year
History of periodontal treatment in the last 6 months
Smoking
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization Patients will be divided into control and intervention groups using simple random allocation method and random number table. Randomization tool: Through the website https://www.graphpad.com/quickcalcs/randomize1/, the total sample size is 90 people who were randomly divided into two groups of 45 people and a random table was provided to the researcher and based on it. The control and intervention group is determined. The randomization process is performed by the study methodology consultant and clinical researchers are not aware of the randomization process and will not have the authority to change or predict the status of individuals.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person evaluating the activity index of lupus erythematosus is not aware of the allocation of patients to intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Shahid Bahonar Square
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.SSU.REC.1398.059
Health conditions studied
1
Description of health condition studied
Systemic lupus erythematosus
ICD-10 code
M32.9
ICD-10 code description
Systemic lupus erythematosus, unspecified
Primary outcomes
1
Description
Probing depth
Timepoint
At the beginning of the study (before the intervention) and 3 months after the start of the study
Method of measurement
With Williams Probe
2
Description
Clinical attachment loss
Timepoint
At the beginning of the study (before the intervention) and 3 months after the start of the study
Method of measurement
With Williams Probe
3
Description
Bleeding index
Timepoint
At the beginning of the study (before the intervention) and 3 months after the start of the study
Method of measurement
Percentage of bleeding around the entire teeth after 30 seconds after probing
4
Description
Plaque index
Timepoint
At the beginning of the study (before the intervention) and 3 months after the start of the study
Method of measurement
Percentage of plaque accumulation around tooth surfaces after evaluation with a disclosingagent
5
Description
Systemic lupus erythematosus disease activity index
Timepoint
At the beginning of the study (before the intervention) and 3 months after the start of the study
Method of measurement
Numerically from 0 to 105 with Q * MD software
6
Description
C-Reactive protein (CRP)
Timepoint
At the beginning of the study (before the intervention) and 3 months after the start of the study
Method of measurement
Record patient test information
7
Description
Erythrocyte Sedimentation Rate (ESR)
Timepoint
At the beginning of the study (before the intervention) and 3 months after the start of the study
Method of measurement
Record patient test information
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 45 patients with moderate to severe chronic periodontitis, at the beginning of the intervention, complete periodontal examinations, scaling and smoothing of root surfaces, Bass technique toothbrushing training with a dental model and a dental model in 10 minutes, registration Laboratory data of acute phase reactive protein (CRP) and erythrocyte sedimentation rate (ESR) and evaluation and recording of systemic lupus erythematosus activity index with Q * MD software, three months later examination and re-registration of the mentioned information.
Category
Treatment - Other
2
Description
Control group: The control group includes patients who are only trained in brushing with Bass technique by lecture method and with a dental model for 10 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital, Yazd
Full name of responsible person
Dr. Hamidreza Bashiri
Street address
Safaieh Street
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۸۷۸۵۷
Phone
+98 35 3822 9007
Email
Sadoghi-hospital@ssu.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Rahnemoun Hospital
Full name of responsible person
Dr. Hamidreza Bashiri
Street address
Bahonar Blvd
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3626 0001
Email
drdehghani@ssu.ac.ir
3
Recruitment center
Name of recruitment center
Shahid Sadoughi School of Dentistry, Yazd
Full name of responsible person
Kimiya Sezavar
Street address
Deh Fajr Street
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3830 1535
Email
k.sezavar@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Hassan Mozaffari
Street address
Shahid Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916844933
Phone
+98 35 1724 9333
Email
mozaffari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
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
Yazd University of Medical Sciences
Full name of responsible person
Fahimeh Rashidi
Position
Periodontist
Latest degree
Specialist
Other areas of specialty/work
Periodontist
Street address
Deh Fajr Street
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 1724 9333
Email
f-rashidi63@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Kimiya Sezavar
Position
Resident Periodontics
Latest degree
Medical doctor
Other areas of specialty/work
Resident Periodontics
Street address
Deh Fajr Street
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 1724 9333
Email
k.sezavar@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Kimiya Sezavar
Position
Resident Periodontics
Latest degree
Medical doctor
Other areas of specialty/work
Resident Periodontics
Street address
Deh Fajr Street
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 1724 9333
Email
k.sezavar@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Accurate data collection method: In this study, periodontal status and severity of systemic lupus erythematosus for each patient at the beginning and after three months of treatment are evaluated based on the following clinical and laboratory parameters: Envelope depth, Clinical Attachment loss , bleeding index and plaque. Evaluation of systemic lupus erythematosus disease activity index and acute phase reactive protein (CRP) and erythrocyte sedimentation rate (ESR)
Data analysis method: After collecting the data, we encode them and enter them into the computer and are paired using SPSS 23 software and T-Tset tests and their independent or non-parametric equivalent and chi-square test and test. Fisher's exact results are analyzed.
When the data will become available and for how long
After collecting and analyzing data
To whom data/document is available
Executors of research projects
Under which criteria data/document could be used
If periodontal treatments affect the severity of SLE, because by providing effective solutions to improve oral health and more emphasis on hygiene, we can reduce the severity of SLE and impose heavier costs on the disease materially and Spiritual (qualitative) prevented.
From where data/document is obtainable
Executors of research projectsدر
What processes are involved for a request to access data/document
Requesting data requires the written consent of all research project implementers.