## Protocol Section
### Identification Module
**NCT ID:** NCT02577679

**Brief Title:** Associations Between Periodontitis and Autoimmune Antibodies in Rheumatoid Arthritis Disease

**Official Title:** Associations Between Periodontitis and Autoimmune Antibodies in Rheumatoid Arthritis Disease

#### Organization Study ID Info
**ID:** 201503116RINA
#### Organization
**Class:** OTHER
**Full Name:** National Taiwan University Hospital
### Status Module
#### Completion Date
**Date:** 2015-11

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2015-10-16

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-10-14

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2015-09

**Type:** ACTUAL

#### Start Date
**Date:** 2015-06

**Status Verified Date:** 2015-10

#### Study First Post Date
**Date:** 2015-10-16
**Type:** ESTIMATED
**Study First Submit Date:** 2015-09-23
**Study First Submit QC Date:** 2015-10-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** National Taiwan University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this case control study is to explore the possible association between periodontal destruction and serum anti-CCP antibodies in RA patients and healthy subjects.

**Detailed Description:** In patients with RA, the anti-CCP antibody titer seems positively correlated to their periodontal destruction and disease activity in comparison with healthy subjects.

### Conditions Module

**Conditions:**

- Periodontitis, Rheumatoid Arthritis, Autoimmunity,

**Keywords:**

- Dentistry

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 47

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Lower then 7 Unit/milliliter: negative 7-10 Unit/milliliter: weak positive Higher then 10 Unit/milliliter: positive

**Measure:** Serum level of anti-cyclic citrullinated peptide/protein antibody

**Time Frame:** Base line

**Description:** Lower then 4 millimeter: normal Higher then 4 millimeter: diseased/previously diseased

**Measure:** Periodontal pocket depth and clinical attachment level

**Time Frame:** Baseline

#### Secondary Outcomes

**Description:** Recorded in picogram per milliliter

**Measure:** Serum level of tumor necrotic factor alpha

**Time Frame:** Baseline

**Description:** Recorded in Unit per milliliter

**Measure:** Serum level of anti-mutated citrullinated vimentin

**Time Frame:** Baseline

**Description:** Recorded in picogram per milliliter

**Measure:** Serum level of interleukin 6

**Time Frame:** Baseline

**Description:** Recorded in picogram per milliliter

**Measure:** Serum level of interleukin 17

**Time Frame:** Baseline

### Eligibility Module

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 60 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Physically healthy persons, especially free of any autoimmune diseases, DM, CVD. No history of periodontal treatment.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Taipei

**Country:** Taiwan

**Facility:** National Taiwan University Hospital

**Zip:** 100

#### Overall Officials

**Official 1:**

**Affiliation:** Assistant professor

**Name:** Yi-Wen Chen, PhD

**Role:** STUDY_DIRECTOR

## 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

### Condition Browse Module - Browse Branches

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M4476

- Name: Arthritis

- Relevance: HIGH

- As Found: Arthritis

- 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: 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

### Condition Browse Module - Meshes

- ID: D000001168

- Term: Arthritis

- ID: D000001172

- Term: Arthritis, Rheumatoid

- ID: D000010518

- Term: Periodontitis

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4625

- Name: Autoantibodies

- Relevance: LOW

- As Found: Unknown

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
