CTRI Number |
CTRI/2016/03/006751 [Registered on: 21/03/2016] Trial Registered Retrospectively |
Last Modified On: |
04/10/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Association between joint pain and gum diseases |
Scientific Title of Study
|
“Effect of Non-Surgical Periodontal Therapy on Chronic Periodontitis and Rheumatoid Arthritis and a correlation of Anti-Citrullinated Protein Antibody (ACPA) levels in South Indian Population†|
Trial Acronym |
RA-CP |
Secondary IDs if Any
|
Secondary ID |
Identifier |
U1111-1177-5767 |
UTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Kaveri A |
Designation |
MDS Student |
Affiliation |
Tamilnadu Government Dental College and Hospital |
Address |
Tamilnadu Government Dental College and Hospital
Chennai
Tamil nadu
Chennai TAMIL NADU 600003 India |
Phone |
9962793370 |
Fax |
|
Email |
kaavs.arunachalam@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Jaishree Tukaram Kshirsagar |
Designation |
Professor |
Affiliation |
|
Address |
Tamilnadu Government Dental College and Hospital
Chennai
Tamil nadu
Chennai TAMIL NADU 600003 India |
Phone |
9498031450 |
Fax |
|
Email |
jaishreekt@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DrSRajeswari |
Designation |
Professor and Head |
Affiliation |
Madras Medical College and Government General Hospital, Chennai |
Address |
Institute of Rheumatology,
Madras Medical College and Government General Hospital,
Chennai
Chennai TAMIL NADU 600003 India |
Phone |
9444174759 |
Fax |
|
Email |
calling_raji@yahoo.com |
|
Source of Monetary or Material Support
|
Department of Rheumatology, Madras Medical College and Tamilnadu Government Dental College and Hospital |
|
Primary Sponsor
|
Name |
Institute of RheumatologyMadras Medical College |
Address |
Institute of Rheumatology,Madras Medical College and Government General Hospital, Chennai-3 |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Kaveri A |
Madras medical college and Tamilnadu Government Dental College Hospital |
OP.NO.29, institute of rheumatology and Room.no.2 department of periodontics Chennai TAMIL NADU |
9962793370
kaavs.arunachalam@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee,Tamil Nadu Government Dental College and Hospital, Chennai |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
, Rheumatoid arthritis patients treated as Out patients in Department of Rheumatology, Madras Medical College suffering from chronic periodontitis , (1) ICD-10 Condition: M056||Rheumatoid arthritis with involvement of other organs and systems, (2) ICD-10 Condition: M056||Rheumatoid arthritis with involvement of other organs and systems, (3) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
effect of non-surgical periodontal treatment in patients with Rheumatoid arthritis and periodontitis |
rheumatoid arthritis patients already taking medications from Department of Rheumatology are recruited tested for presence of periodontitis and one group receives treatment while the other is control group,will receive treatment at the end of 3 months |
Comparator Agent |
patients with rheumatoid arthritis and periodontitis not receiving non-surgical periodontal therapy |
DAS 28 score is calculated at baseline and at 3 months without receiving non-surgical periodontal therapy. |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Patients willing for voluntary participation and have signed informed consent.
2. Age group: 30- 65 years old.
3. Either sex.
4. under medication for rheumatoid arthritis
Patients taking DMARD- disease modifying anti-rheumatic drugs for atleast 6 months
5. Having atleast 8 teeth
6. Periodontal disease (at least 1 site with PPD>4mm, clinical attachment loss > 3mm)
7. Available for the study for a period of 6 months
|
|
ExclusionCriteria |
Details |
1. Recent history of hospitalization.
2. Acute generalized infection/chronic systemic infection necessitating chronic antibiotic intake.
3. Acute oral infection or condition necessitating extraction/suspected premalignant lesions/conditions in the mouth
4. Patients with uncontrolled, Hypertension, Cardiovascular, Respiratory, Renal disorder.
5. Patients in need of any change or increase in dosage of DMARD drugs.
6. Patients with diabetes mellitus, psoriatic arthritis, ankylosing spondylitis
7. Current smokers
8. Pregnancy or lactation at the time of inclusion.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Change in DAS 28 Disease Activity Score in Rheumatoid patients with Chronic periodontitis |
3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Quality of Life Index (QOLI) in rheumatoid arthritis patients |
3 months |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
01/06/2015 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="6" Days="15" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Malathi K, Aruna Kaveri
International Journal of The Association Between Chronic Periodontitis and Rheumatoid Arthritis-A Review
Scientific and Research Publications, Volume 4, Issue 4, April 2014 |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
“Effect of Non-Surgical Periodontal Therapy on Chronic Periodontitis and Rheumatoid Arthritis and a correlation of Anti-Citrullinated Protein Antibody (ACPA) levels in South Indian Population†Introduction Chronic periodontitis is found associated with a number of systemic conditions like diabetes mellitus, atherosclerosis, coronary heart disease and some chronic inflammatory disorders including rheumatoid arthritis. Among these, the association of rheumatoid arthritis with chronic periodontitis has been widely studied and researched. Rheumatoid Arthritis (RA) and Chronic Periodontitis (CP) share certain common features like both being chronic inflammatory diseases associated with bone loss and destruction of the soft tissue surrounding the bone. Exacerbation of RA signs in patients with CP and incidence of increased CP in patients with RA also have been reported. Many possible mechanisms have been proposed to explain the association of periodontitis and rheumatoid arthritis. Oral infections contributing to the pathogenesis of RA is one such theory. Causative factor of chronic periodontitis is the plaque with its bacterial biofilm. The inflammatory process due to this biofilm results in destruction of the periodontal ligament and alveolar bone. The exact etiology of RA is unknown. It is believed ‘RA is triggered by exposure of an immnunogenetically susceptible host to an arthritogenic microbial antigen’ This sets up autoimmune reaction with local release of inflammatory mediators and lytic cytokines, resulting in destruction of the joint. Host derived inflammatory mediators such as cytokines, prostaglandins and matrix metalloproteinases - MMPs are believed to be responsible for the progression of CP and also in the pathogenesis of RA. The highly pathogenic bacteria P. gingivalis is one of the key pathogen in periodontitis. P.gingivalis is believed to be the only known bacterium that could express the enzyme Peptidyl Arginine Deiminase (PAD). PAD enzyme through citrullination cause post-translational modification of structure of proteins. this results in generation of auto-immunity to these citrullinated peptides. In RA antibodies to citrullinated protein such as keratin, filagrin, fibrin, vimentin, fibrinogen as well as Anticyclic Citrullinated Protein Antibodies -(ACPA). Among these ACPA are regarded as highly specific for RA. Thus oral infection by P.infection could contribute to development of RA. Significant reduction in Disease Activity Score (DAS 28) of rheumatoid arthritis, improvement in quality of life (QOL) and reduction of Probing pocket depth (PPD) of periodontium have been reported by few authors abroad, following non-surgical periodontal therapy. But such studies have not been reported in India till now, although few authors tried to analyze whether there is an association between RA and CP. This study focuses on the clinical parameters of both disorders- RA and CP following non-surgical periodontal therapy and analyse if there is a reduction in severity of both these diseases thereby correlating the severity of RA and CP with ACPA. |