Effect of Endodontic Treatment on Inflammatory Markers, Disease Activity and Periapical Healing in Rheumatoid Arthritis Patients With Apical Periodontitis : A Prospective Interventional Study

SUMMARY TITLE: "Effect of endodontic treatment on inflammatory markers, disease activity and periapical healing in rheumatoid arthritis patients with apical periodontitis"

RATIONALE: Chronic inflammation plays a pivotal role in rheumatoid arthritis as subjects present with elevated serum levels of numerous cytokines such as IL-1, IL-6, 1L-12, IL-17, tumour necrosis factor-alpha, RANK and RANK Ligand. Periodontal and pulpal inflammation are two major low grade chronic inflammatory diseases of the oral cavity. Apical periodontitis extends from the chronic inflammatory process that originated in the dental pulp to surround the apex of the tooth. Thus Rheumatoid arthritis and apical periodontitis converge upon common pathway of inflammation. The scientific literature has also shown to provide potential link between endodontic infection and rheumatoid arthritis. The evidence of increased prevalence of apical periodontitis in subjects of rheumatoid arthritis is provided mainly by cross-sectional and case control studies. Interventional studies have been performed in subjects with rheumatoid arthritis and periodontal disease, with results depicting beneficial effect of periodontal therapy in patients of rheumatoid arthritis. To best of our knowledge no interventional study has been performed to assess the healing pattern of apical periodontitis in subjects of rheumatoid arthritis and subsequently effect of endodontic intervention on inflammatory profile and disease burden in the same.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis AND Apical Periodontitis
• Intervention / Treatment: Procedure: ROOT CANAL TREATMENT

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BHAVIKA BANSAL; Phone Number: 8288984027; Email: bhavikabansal98@yahoo.in
• Study Contact Backup: Name: mayank arora; Phone Number: 8295964200; Email: dr_arora002@yahoo.in

Study Locations

• India
  • Rohtak, India, 124001
    • Recruiting
    • Rheumatology clinic PGIMS ROHTAK
    • Contact: mayank arora; Phone Number: 8295964200; Email: dr_arora002@yahoo.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1. Age of patients 30-65 years 2.Definite diagnosis of Rheumatoid arthritis based on ACR/EULAR 2010 criteria[28] i.e a score of 6 or greater out of 10 from the individual scores in four domains: number and site of involved joints (range 0-5), serological abnormality (range 0-3), elevated acute-phase response (range 0-1) and symptom duration (two levels; range 0-1) 3. The periapical index (PAI) will be used to evaluate the periapical status patients with PAI >or=3 as given by Orstavik[29] will be included 4. Presence of total teeth >/= 12

Exclusion Criteria:

1. Patients with periodontitis, pocket depth and CAL>5mm (stage 3, 4) will be excluded.
2. Pregnancy; lactation & contraceptives
3. Patients with any other systemic disease other than Rheumatoid arthritis i.e Diabetes, HIV, Chronic Liver Disease, Chronic Kidney disease and Cardiovascular disease

5. Conditions known to alter systemic inflammatory markers i.e orthopaedic trauma, surgery and viral infections 6. Patients with BMI >/= 30 7. Medications (during last 3 months) known to affect systemic inflammatory markers (systemic steroids, immunosuppressants, hormone replacement therapy, contraceptives and systemic antibiotics) 8. Smoking

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rhuematoid arhtritis patients; Rhuematoid arhtritis patients: Change in PAI, hsCRP, ESR, SDAI and quality of life using OHIP-14 will be assessed post root canal treatment	Procedure: ROOT CANAL TREATMENT; ROOT CANAL TREATMENT
Active Comparator: Systemically healthy patients; Systemically healthy patients: Change in PAI, hsCRP, ESR, and quality of life using OHIP-14 will be assessed post root canal treatment	Procedure: ROOT CANAL TREATMENT; ROOT CANAL TREATMENT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in levels of hsCRP	12 MONTHS

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in levels of ESR	12 MONTHS
Change in SDAI	12 MONTHS
Quality of life using OHIP-14	12 MONTHS

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Jaw Diseases; Periapical Diseases; Arthritis; Arthritis, Rheumatoid; Periodontitis; Periapical Periodontitis
• Other Study ID Numbers: Bhavika Bansal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No