Objective: Assessing the effect of periodontal treatment on rheumatoid arthritis activity based on disease activity score, ESR and CRP.
Study design: clinical trial, not blind, unicenter, phase three.
The study population: patients with rheumatoid arthritis and periodontitis simultaneously who were selected randomly.
Inclusion criteria: 18 years and older; diagnosis of RA at least one year ago; disease activity score between 3.2 and 5.1; having at least six natural teeth; the patient be educable; having gingivitis with mild to moderate degree.
The exclusion criteria were: risk of infection; serious liver or kidney diseases; chronic infectious disease that needs to frequent use of antibiotics; uncontrolled diabetes; taking anti-thrombotic and biologic therapy; sensitivity to chlorhexidine gluconate (oral rinse); contraindication of amoxicillin and metronidazole; severe oral problems which requiring immediate surgery; pregnancy, breast-feeding or if want to get pregnant during the study period; any febrile or chronic diseases.
Sample Size: The sample size is 30.
Interventions: At first, DAS-28 questionnaire filled and if periodontitis confirmed by dentist, treatment initiated which is includes non surgical scaling, root planning, systemic antibiotics, antiseptic (chlorhexidine) and oral health education. At the end of treatment period and confirming of complete remission by dentist, on days 45 and 90 after initiation all patients will be visited by rheumatologist and DAS-28 questionnaire completed again. ESR and CRP are also measured at each visit in a reference laboratory.
Time of Intervention: at first day and 45 and 90 days later re-evaluation is done by a rheumatologist.
The primary outcome or consequences of the study: improvement of rheumatoid arthritis activity score and lowering of ESR and CRP level.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122512823N3
Registration date:2016-01-04, 1394/10/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-01-04, 1394/10/14
Registrant information
Name
Jamileh Moghimi
Name of organization / entity
Semnan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 23 1332 8017
Email address
moghimi_jam@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Semnan University of Medical Sciences
Expected recruitment start date
2016-01-05, 1394/10/15
Expected recruitment end date
2016-07-04, 1395/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the treatment of periodontitis on rheumatoid arthritis disease activity in patients who referred to Rheumatology clinic, Semnan
Public title
The effect of the treatment of periodontitis on rheumatoid arthritis disease activity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 18 years and older; diagnosis of RA at least one year ago; disease activity score between 3.2 and 5.1; having at least six natural teeth; the patient be educable; having gingivitis with mild to moderate degree.
The exclusion criteria were: risk of infection; serious liver or kidney diseases; chronic infectious disease that needs to frequent use of antibiotics; uncontrolled diabetes; taking anti-thrombotic and biologic therapy; sensitivity to chlorhexidine gluconate (oral rinse); contraindication of amoxicillin and metronidazole; severe oral problems which requiring immediate surgery; pregnancy, breast-feeding or if want to get pregnant during the study period; any febrile or chronic diseases.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
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
Ethical Commettee of Semnan University of Medical Sicenses
Street address
Basidj Boulevard
City
Semnan
Postal code
3519747167
Approval date
2015-12-01, 1394/09/10
Ethics committee reference number
IR.SEMUMS.REC.1394.122
Health conditions studied
1
Description of health condition studied
Periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
2
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified
Primary outcomes
1
Description
Rheumatoid arthritis activity
Timepoint
Before initiation of interventions, 45 and 90 days after intervention
Method of measurement
DAS-28 questionnaire
Secondary outcomes
1
Description
Erythrocyte Sedimentation Rate
Timepoint
Before initiation of interventions, 45 and 90 days after intervention
Method of measurement
Laboratory test
2
Description
C- reactive protein
Timepoint
Before initiation of interventions, 45 and 90 days after intervention
Method of measurement
Laboratory test
Intervention groups
1
Description
Interventions: At first, DAS-28 questionnaire filled and if periodontitis confirmed by dentist, treatment initiated which is includes non surgical scaling, root planning, systemic antibiotics (metronidazole 500 mg three time per day and amoxicillin 500 mg three time per day for a ten days period), antiseptic (Chlorhexidine gluconate oral rinse 0.12% 2 time per day) and oral health education. At the end of treatment period, on 20th day of study all patients will be visited by dentist and if he confirm complete remission, on days 45 and 90 after initiation all patients will be visited by rheumatologist and DAS-28 questionnaire completed again. ESR and CRP are also measured at each visit in a reference laboratory
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Dr. Amir Hassani
Street address
Basidj Boulevard, Amin Avenue
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Reza Asgari
Street address
Basij Bulvard
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Jamileh Moghimi
Position
Rheumatologist/ Associate Professor
Other areas of specialty/work
Street address
Kowsar Hospital, Basidj Boulevard, Amin Avenue
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7821
Fax
Email
moghimi_jam@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Jamileh Moghimi
Position
Rheumatologist/ Associate professor
Other areas of specialty/work
Street address
Kowsar hospital, Amin Avenue, Basidj Boulevard
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7821
Fax
Email
moghimi_jam@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research expert
Other areas of specialty/work
Street address
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7821
Fax
Email
mehrdadzahmatkesh@semums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)