FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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)  

            â€œEffect 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.

 

 
Close