Effect of Nonsurgical Periodontal Therapy (NSPT) on Rheumatoid Arthritis Subjects With Periodontitis

NCT05880303 | Completed DMC

• 1 other identifier: 2019813-7736
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis; Periodontitis

Keywords

periodontitis; rheumatoid arthritis; nonsurgical periodontal therapy; professional mechanical plaque removal; oral hygiene education

Outcome Measures

Primary Outcomes (2)

• Change in anti-carbamylated protein antibodies.

  The anticarbamylayed protein antibody is positive when the ELISA results exceeds a cut-off value of 6ng/mL.

  6 months

• Differential regulation in oral bacterial proteins

  The protein regulation will be measured using proteomic technology with PEAKS X+ software. If the proteins are detected in both test group and control group, significant results are considered if there is \>2 fold change, occur in \>50% of the subjects, and the p-value is \<0.05. If proteins are only detected in either group, criteria to be used to consider a significant change is that the proteins are detected in \>50% of the subjects in the respective group.

  6 months

Secondary Outcomes (4)

• Change in probing pocket depth (PPD)

  6 months

• Change in Anti-citrullinated protein levels

  6 months

• Change in Disease Activity Score 28-Erythrocyte sedimentation rate (DAS28-ESR) score.

  6 months

• Change in myeloperoxidase

  6 months

Study Arms (2)

Nonsurgical periodontal therapy

EXPERIMENTAL

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).

Procedure: Nonsurgical periodontal therapy

Delayed treatment

NO INTERVENTION

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.

Interventions

Nonsurgical periodontal therapy PROCEDURE

Oral Hygiene education, scaling and root surface debridement at baseline and 3 months

Also known as: Professiona mechanical plaque removal and root surface instrumentation

Nonsurgical periodontal therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 3 sites with probing pocket depths (PPD) ≥4mm and 4 sites with clinical attachment level (CAL) ≥4mm distributed in at least 2 quadrants (Papapanou et al, 2018) and will be designated as having Stage II and Stage III periodontitis
• Patients should have a minimum of 12 teeth present.

You may not qualify if:

• Patients who are on antibiotic use during the previous 3 months before study
• Patients who have received nonsurgical periodontal treatment within 4 months before the study.
• Patients who have any concurrent systemic or debilitating conditions such as uncontrolled diabetes.
• Non Malaysian subjects
• Patients who are pregnant
• Presence of acute dental pain or infections

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Universiti Malaya

Kuala Lumpur, Kuala Lumpur, 56100, Malaysia

Location

Related Publications (3)

• Lew PH, Rahman MT, Safii SH, Baharuddin NA, Bartold PM, Sockalingam S, Kassim NLA, Vaithilingam RD. Antibodies against citrullinated proteins in relation to periodontitis with or without rheumatoid arthritis: a cross-sectional study. BMC Oral Health. 2021 Jul 20;21(1):360. doi: 10.1186/s12903-021-01712-y.

  PMID: 34284769 BACKGROUND

• Lee YH, Lew PH, Cheah CW, Rahman MT, Baharuddin NA, Vaithilingam RD. Potential mechanisms linking periodontitis to rheumatoid arthritis. J Int Acad Periodontol. 2019 Jul 1;21(3):99-110.

  PMID: 31473702 BACKGROUND

• Lee YH, Baharuddin NA, Chan SW, Rahman MT, Bartold PM, Sockalingam S, Vaithilingam RD. Localisation of citrullinated and carbamylated proteins in inflamed gingival tissues from rheumatoid arthritis patients. Clin Oral Investig. 2021 Mar;25(3):1441-1450. doi: 10.1007/s00784-020-03452-9. Epub 2020 Jul 12.

  PMID: 32656595 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rathna Devi Vaithilingam, MCD(Perio)

  Universiti Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: single-blinded parallel arm study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled clinical trial with two parallel groups (intervention versus delayed treatment), with a balanced 1:1 treatment allocation and with 6 months follow-up for both groups.

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 30, 2023
• Study Start: June 1, 2023
• Primary Completion: May 31, 2025
• Study Completion: October 30, 2025
• Last Updated: December 5, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication of research
• Access Criteria: To anyone who wishes to access the data.

Locations

MY (1)