Effect of Nonsurgical Periodontal Therapy (NSPT) on Inflammatory Mediators, Subgingival Microbiota and Quality of Life Impacts in Rheumatoid Arthritis Subjects With Periodontitis

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Periodontitis (PD), a chronic inflammatory disease which results in irreversible attachment loss, bone destruction and, if left untreated, tooth loss. Rheumatoid arthritis (RA), is an autoimmune disease characterized as a chronic inflammatory disorder leading to synovial inflammation and destruction of cartilage and bone. RA and PD which are commonly seen in elderly have many similarities in terms of pathophysiology and clinical progression. Previous findings from the investigators reported that inflamed periodontal tissues of RA subjects with PD are a potential site for post translational modification of proteins as there was increase in presence of citrullinated and carbamylated proteins in gingival tissues. Autoantibodies to these proteins have been reported to be involved in loss of immune tolerance which leads to RA and its progression. Currently there are gaps in our knowledge concerning the effect of nonsurgical periodontal therapy (NSTP), comprising oral hygiene instructions, scaling and root surface debridement on presence of these autoantibodies and inflammatory outcomes of RA. It is hypothesized that reduction in periodontal inflammation may concurrently reduce the systemic inflammatory load which is responsible in perpetuating RA joint inflammation. Here, the investigators propose to perform a randomized, controlled, single-blinded study on RA subjects with stage 2 or 3 periodontitis to assess the effect of NSTP on the reduction of these autoantibodies and inflammatory mediators as well as RA related disease activity measures such as ESR, CRP and Disease Activity Score 28-joint count (DAS28). The investigators will also assess changes in subgingival microbiota associated with RA-PD in response to NSTP using next generation sequencing. This study will help determine if RA individuals could benefit from early and appropriate NSPT, thus reducing periodontal inflammation and a similar impact on RA disease could be expected. This will ultimately improve patients' quality of life and reduce societal burden related to increased patient discomfort and treatment costs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• All RA patients who fulfill the American College of Rheumatology (formerly the American Rheumatism Association) 2010 revised criteria for the classification of RA and who are unresponsive to conventional RA treatment.

• At least 4 sites with probing pocket depths (PPD) ≥5mm and 4 sites with clinical attachment level (CAL) ≥3mm distributed in at least 2 quadrants (Papapanou et al, 2018) and will be designated as having Stage II and Stage III periodontitis in addition to Bleeding on Probing (BoP) score of \>30% representing generalised inflammation (Chapple et al, 2017)

• Patients should have a minimum of 14 teeth present.

Locations
Other Locations
Malaysia
Universiti Malaya
RECRUITING
Kuala Lumpur
Contact Information
Primary
Rathna Devi Vaithilingam, MCD(Perio)
rathna@um.edu.my
+60162210065
Backup
Chia Wei Cheah, PhD
chiawei@um.edu.my
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 40
Treatments
Experimental: Nonsurgical periodontal therapy
Subjects in the IG will be given non-surgical periodontal treatment comprising of oral hygiene instructions, scaling and root surface debridement. Scaling will be carried out with ultrasonic scaler. For root surface debridement (for sites with PPD \>4mm), local anaesthetic will be administered and ultrasonic scaler and Gracey curettes will be used. The scaling and root surface debridement will be done in 2 sittings over 2 different days within a week. Oral hygiene instructions and additional supportive scaling and root surface debridement will be repeated at 3 months and 6 months if judged necessary (presence of sites with BOP and/or PPD ≥5mm).
No_intervention: Delayed treatment
Oral hygiene instructions at baseline and will be repeated at 3 months and 6 months. All subjects will receive scaling and root surface debridement at the end of the 6 month trial.
Sponsors
Leads: University of Malaya

This content was sourced from clinicaltrials.gov