## Protocol Section
### Identification Module
**NCT ID:** NCT06433232

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

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

#### Organization Study ID Info
**ID:** Bhavika Bansal
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### Status Module
#### Completion Date
**Date:** 2025-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Postgraduate Institute of Dental Sciences Rohtak

#### Responsible Party

**Investigator Affiliation:** Postgraduate Institute of Dental Sciences Rohtak

**Investigator Full Name:** Sanjay Tewari

**Investigator Title:** principal pgids

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Rheumatoid Arthritis AND Apical Periodontitis

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 76

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Rhuematoid arhtritis patients: Change in PAI, hsCRP, ESR, SDAI and quality of life using OHIP-14 will be assessed post root canal treatment

**Intervention Names:**

- Procedure: ROOT CANAL TREATMENT

**Label:** Rhuematoid arhtritis patients

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Systemically healthy patients: Change in PAI, hsCRP, ESR, and quality of life using OHIP-14 will be assessed post root canal treatment

**Intervention Names:**

- Procedure: ROOT CANAL TREATMENT

**Label:** Systemically healthy patients

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Rhuematoid arhtritis patients

- Systemically healthy patients

**Description:** ROOT CANAL TREATMENT

**Name:** ROOT CANAL TREATMENT

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Change in levels of hsCRP

**Time Frame:** 12 MONTHS

#### Secondary Outcomes

**Measure:** Change in levels of ESR

**Time Frame:** 12 MONTHS

**Measure:** Change in SDAI

**Time Frame:** 12 MONTHS

**Measure:** Quality of life using OHIP-14

**Time Frame:** 12 MONTHS

### Eligibility Module

**Eligibility Criteria:** 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

-

**Gender Based:** True

**Gender Description:** ender matched healthy control participants to the same gender rheumatoid arthritis individuals will be analyzed.

**Healthy Volunteers:** True

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bhavikabansal98@yahoo.in

**Name:** BHAVIKA BANSAL

**Phone:** 8288984027

**Role:** CONTACT

**Contact 2:**

**Email:** dr_arora002@yahoo.in

**Name:** MAYANK ARORA

**Phone:** 8295964200

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rohtak

**Contacts:**

***Contact 1:***

- **Email:** dr_arora002@yahoo.in

- **Name:** mayank arora

- **Phone:** 8295964200

- **Role:** CONTACT

**Country:** India

**Facility:** Rheumatology clinic PGIMS ROHTAK

**Status:** RECRUITING

**Zip:** 124001

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000010483

- Term: Periapical Diseases

- ID: D000007571

- Term: Jaw Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4476

- Name: Arthritis

- Relevance: HIGH

- As Found: Arthritis

- ID: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M13395

- Name: Periapical Periodontitis

- Relevance: HIGH

- As Found: Apical Periodontitis

- ID: M4480

- Name: Arthritis, Rheumatoid

- Relevance: HIGH

- As Found: Rheumatoid Arthritis

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13393

- Name: Periapical Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10601

- Name: Jaw Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001168

- Term: Arthritis

- ID: D000001172

- Term: Arthritis, Rheumatoid

- ID: D000010518

- Term: Periodontitis

- ID: D000010485

- Term: Periapical Periodontitis

### Misc Info Module

- Version Holder: 2024-05-31
