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

NCT ID: NCT06433232

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-31

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis AND Apical Periodontitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

ROOT CANAL TREATMENT

Intervention Type PROCEDURE

ROOT CANAL TREATMENT

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

Group Type ACTIVE_COMPARATOR

ROOT CANAL TREATMENT

Intervention Type PROCEDURE

ROOT CANAL TREATMENT

Interventions

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ROOT CANAL TREATMENT

ROOT CANAL TREATMENT

Intervention Type PROCEDURE

Eligibility Criteria

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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

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Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Sanjay Tewari

principal pgids

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rheumatology clinic PGIMS ROHTAK

Rohtak, , India

Site Status RECRUITING

Countries

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India

Central Contacts

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BHAVIKA BANSAL

Role: CONTACT

8288984027

MAYANK ARORA

Role: CONTACT

8295964200

Facility Contacts

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mayank arora

Role: primary

8295964200

Other Identifiers

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Bhavika Bansal

Identifier Type: -

Identifier Source: org_study_id

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