Objective: Effect of phase one of periodontal treatment on improvement of clinical signs of Rheumatoid Arthritis.
Design: This study is an interventional clinical trial.
Settings and conduct: In this study, severity of clinical signs of arthritis is compared before and after phase one of periodontal treatment in different intervals. For the half of the Rheumatoid Arthritis patients phase one of periodontal treatment is performed and the other half considered as control group without any periodontal treatments.
Participants including major eligibility criteria: 42 samples are selected from patients with rheumatoid arthritis referred to KHatam-ol-anbia clinic in Yazd.
Inclusion criteria: Confirmed diagnosis of arthritis; generalized moderate to severe periodontitis; no antibiotic usage during the previous 3 months before study; no smoking or diabetes or heart diseases; no pregnancy and informed consent.
Exclusion criteria: Irregular maintenance visits; improper plaque control in case group.
Intervention: Phase one of periodontal treatment performance in case group.
Main outcomes variables: DAS28 index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202219104N1
Registration date:2012-04-07, 1391/01/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-07, 1391/01/19
Registrant information
Name
Fahimeh Rashidi Meybodi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1621 2222
Email address
fatarbashim@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2011-09-06, 1390/06/15
Expected recruitment end date
2012-03-05, 1390/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of phase one of periodontal treatment on improvement of clinical signs of Rheumatoid Arthritis
Public title
Effect of phase one of periodontal treatment on improvement of clinical signs of Rheumatoid Arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Confirmed diagnosis of arthritis; generalized moderate to severe periodontitis; no antibiotic usage during the previous 3 months before study; no smoking or diabetes or heart diseases; no pregnancy and filling informed consent.
Exclusion criteria: Irregular maintenance visits; improper plaque control in case group.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Bahonar square, Yazd
City
Yazd
Postal code
89169178477
Approval date
2011-07-19, 1390/04/28
Ethics committee reference number
p/17/1/50352
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified
Primary outcomes
1
Description
(Disase Activity Score 28)
Timepoint
Beginning of the study- 8 weeks after intervention
Method of measurement
A digit without any units. Different parts of this index are put in special formula and one digit is recorded.
Secondary outcomes
1
Description
Probing depth
Timepoint
Before intervention-8 weeks after intervention
Method of measurement
Millimeter and with using periodontal prob.
2
Description
MGI
Timepoint
Before intervention- 8 weeks after intervention
Method of measurement
A digit between 0 and 4. It doesnt need any tools and is completely observational.
3
Description
BOP
Timepoint
Before intervention-8 weeks after intervention
Method of measurement
Percentage- After stimulation with periodontal prob,the sites with bleeding are recorded as percentage of all sites.
Intervention groups
1
Description
Scaling and root planning (phase one of periodontal treatment protocol) is done in case group.
This intervention is done by ultrasonic device, so all calculus and deposits will be removed from teeth surfaces.
Category
Treatment - Other
2
Description
No intervention is done in control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam-ol-anbia Clinic
Full name of responsible person
Dr Ali Dehghan
Street address
Taleghani avenue,Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Fatemeh Ezzoddini- vice chancellor for reasearch
Street address
Bahonar square, Yazd
City
Yazd
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,Shahid Sadoughi 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
Shahid Sadoughi school of dentistry
Full name of responsible person
Fahimeh Rashidi Meybodi
Position
Post-graduate student of periodontology department
Other areas of specialty/work
Street address
Fazaye-Sabz crossroad, Dahe-Fajr blv, Yazd
City
Yazd
Postal code
Phone
+98 35 1828 6835
Fax
Email
rashidimeibodi.fahimeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd school of dentistry
Full name of responsible person
Dr.Fazeleh Attarbashi Moghaddam
Position
assistant professor
Other areas of specialty/work
Street address
Fazaye-Sabz crossroad, Dahe- Fajr blv, Yazd
City
Yazd
Postal code
Phone
+98 35 1828 6835
Fax
Email
fatarbashim@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi school of dentistry
Full name of responsible person
Fahimeh Rashidi Meybodi
Position
Post-graduate student of periodontology department
Other areas of specialty/work
Street address
Periodontology department, Dental faculty of Shahid Sadoughi University of Medical Sciences, Fazaye-Sabz crossroad,Yazd
City
Yazd
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)