Determination of non-surgical Periodontal treatment impacts on Rheumatoid Arthritis disease severity
Design
Randomized one side blinded clinical trial with controlled group
Settings and conduct
Referred persons to Vali-Asr educational curative hospital in Birjand.
This randomized clinical trial studied on 60 patients that are infected to Rheumatoid Arthritis (based on Euler criteria consist of number and type of engaged joint, ESR & CRP inflammation factors, Serologic factors like RF & Anti CCP and illness duration that should gain at least 6 points totaly) and mild to moderate periodontal disease based on visual examination (positive BOP, marginal inflammation, plaque and scale and lost teeth) that are confirmed by dentist.
Patients are divided into 3 groups (1. under scaling and Antibiotic therapy 2. just under scaling therapy 3. witness). at the beginning and end of study, DAS 28 questionnaire will be filled for all 3 groups.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
1. People older than 18 years
2. Patients that are afflicted to Arthritis disease according to ACR-Eulur criteria
3. Passed at least a year since RA diagnosis
4. Disease infection to gum inflammation with mild to moderate severity
5. Have at least six healthy teeth
6. Not infected to other systemic disease like Leukemia, Diabetes and White blood cell deficiency
7. No Smoking
8. Non-use of effective medicines on Gum Cognitive tissue properties like Nifedipine and Cortico steroids
9. Non-use of Antibiotics over the past 3 months
10. No periodontal treatments over the past 6 months
Exit criteria:
1- Complications
2- Change in the diet during the study period
3. Having systemic diseases such as leukemia, diabetes, white blood cell deficiency, anemia,
Intervention groups
1. Dental scaling
2. Dental scaling and drug therapy
Main outcome variables
RF-CRP-ESR-DAS-Amoxicillin
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20180613040084N1
Registration date:2018-10-10, 1397/07/18
Registration timing:retrospective
Last update:2018-10-10, 1397/07/18
Update count:0
Registration date
2018-10-10, 1397/07/18
Registrant information
Name
Marzie Talaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3257 3381
Email address
marzie.talaei@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-20, 1396/10/30
Expected recruitment end date
2018-04-03, 1397/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Non surgical Periodontal Treatment on the Severity of Rheumatoid Arthritis(RA)
Public title
Effect of dental scaling on Arthritis (RA)
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Passed at least a year since RA diagnosis and disease activity score should be between 1.5 to 3.2
Disease infection to gum inflammation with mild to moderate severity
Have at least six healthy teeth
Not infected to other systemic disease like Leukemia, Diabetes and White blood cell deficiency
No smoking
Non-use of effective medicines on Gum Cognitive tissue properties like Nifedipine and Cortico steroids
Non-use of Antibiotics over the past 3 months
No periodontal treatments over the past 6 months
Exclusion criteria:
infection to systemic disease like Leukemia, Diabetes, White blood cell deficiency, Anemia, Nephropathy, Hepatopathy, AIDS, having Pacemaker and Infectious Endocarditis
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers table
Each member was assigned a number, then the numbers were written on paper, and for each group, 20 numbers were selected.
Blinding (investigator's opinion)
Not 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 Birjand University of Medical Sciences کمیته اخلاق دانشگاه علوم پزشکی بیرجند
Street address
Dentistry faculty, Birjand University of Medical Sciences, Ghaffari street, Birjand, Iran دانشکده دندان پزشکی، دانشگاه علوم پزشکی بیرجند، خیابان غفاری، بیرجند،ایران
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2018-03-09, 1396/12/18
Ethics committee reference number
Ir.bums.REC.1396.353
Health conditions studied
1
Description of health condition studied
Periodontitis_Rheumatoid Arthritis(RA)
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
Description
Improvement of rheumatic pains
Timepoint
Record swelling and pain of rheumatic patients at the beginning of the study (before dental scaling), 45 and 90 days after scaling
Method of measurement
Questionnaire 28 das (disease activity score)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Other
2
Description
Intervention group:
Category
Treatment - Drugs
3
Description
Control group:
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand University of Medical Sciences
Full name of responsible person
Marzie Talaei
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
talaei1993@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tooba Kazemi
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
talaei1993@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Narjes Akbari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
narges-akbare4021@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Narjes Akbari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
narges-akbare4021@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Narjes Akbari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghaffari
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Fax
Email
narges-akbare4012@yahoo.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
Because its not mandatory yet
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Publication of a paper in academic journals
When the data will become available and for how long
From 2019
To whom data/document is available
Anyone who wishes to access the data.
Under which criteria data/document could be used
To achieve the aims in the approved proposal.
From where data/document is obtainable
Proposal may be submitted up to 24 months following article publication
What processes are involved for a request to access data/document
Proposal will be available up to 24 months following article publication.