Association Between Periodontitis and the Level of Anti-citrullinated Protein Antibodies in Rheumatoid Arthritis

• Sponsor: Misr International University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05706493
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 5.9
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

the relationship between rheumatoid arthritis and periodontal disease is crucial and has been explained via a complex interplay of genetic, environmental, and hormonal factors that influence the host immune tolerance leading to both disease characteristics. The aim of this study is to clinically investigate the correlation between the levels of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid before and after non-surgical periodontal treatment and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (RA) patients

Condition or Disease	Intervention/Treatment	Phase
Periodontal Diseases; Rheumatoid Arthritis	Other: Non surgical periodontal treatment	N/A

Detailed Description

the relationship between rheumatoid arthritis and periodontal disease is crucial and has been explained via a complex interplay of genetic, environmental, and hormonal factors that influence the host immune tolerance leading to both disease characteristics.

The aim of this study is to clinically investigate the correlation between the levels of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid before and after non-surgical periodontal treatment and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (RA) patients Materials and Methods: a total of 40 participants suffering from periodontitis and rheumatoid arthritis will be referred from the Badr Hospital (Faculty of Medicine, Helwan University) to Misr international university's dental clinic complex. Gingival crevicular fluid (GCF) samples will be collected from the patients before performing periodontal therapy (baseline). Assessment of ACPAs will be quantified using enzyme-linked immunoassay (ELISA) as the primary outcome at baseline and after 3 months. Assessment of 2ry outcomes includes clinical periodontal and RA parameters at baseline and after 3 months.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: According to the periodontal parameters measured the cases will be categorized according to the latest classification of the 2017 World Workshop of classification of periodontal diseases and conditions as follows: staging of periodontitis is mainly based on the interdental CAL at the site of greatest loss and on radiographic bone loss and on tooth loss, over 4 stages-stage I, initial; stage II, moderate; stage III, severe; and stage IV, advanced periodontitis, Patient periodontal status will be assessed using William's graduated periodontal probe.Non-surgical periodontal treatment will be performed using ultrasonic scaler and subgingival curettesAccording to the periodontal parameters measured the cases will be categorized according to the latest classification of the 2017 World Workshop of classification of periodontal diseases and conditions as follows: staging of periodontitis is mainly based on the interdental CAL at the site of greatest loss and on radiographic bone loss and on tooth loss, over 4 stages-stage I, initial; stage II, moderate; stage III, severe; and stage IV, advanced periodontitis, Patient periodontal status will be assessed using William's graduated periodontal probe.Non-surgical periodontal treatment will be performed using ultrasonic scaler and subgingival curettes
• Masking: None (Open Label)
• Masking Description: there will be two outcome assessor one before the non surgical periodontal treatment and the other one will be after non surgical periodontal treatment with 3 months
• Primary Purpose: Treatment
• Official Title: Association Between Severity of Periodontitis and the Level of Anti-citrullinated Protein Antibodies (ACPAs) in Rheumatoid Arthritis Patients Before and After Non-surgical Periodontal Treatment (Pre and Post Study)
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Non-surgical periodontal treatment assessment of different periodontal parameters and gingival crevicular fluid sampling will be done then non surgical periodontal treatment will be performed then after 3 months re assessment of the periodontal parameters and gingival crevicular fluid sampling will be done	Other: Non surgical periodontal treatment; Non-surgical periodontal treatment will be performed using ultrasonic scaler and subgingival curettes

Outcome Measures

Primary Outcome Measures

1. Change in the level of anti-citrullinated protein antibodies (ACPAs) [at baseline and 3 months]

   assessment of the level of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid

Secondary Outcome Measures

1. Change in Clinical attachment Loss [at baseline and 3 months]

   measuring the distance from the cemento enamel junction to the base of the pocket in mm

2. Change in Probing depth [at baseline and 3 months]

   measuring the distance from the gingival margin to the base of the pocket in mm

3. Change in Plaque index (PI) [at baseline and 3 months]

   it is a score (0,1,2 and 3) where: 0 = No plaque in the gingival area. 1 = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface. 2 = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye. 3 = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Rheumatoid patients fulfilling the ACR criteria for the classification of RA

• 18 years

• Both genders

• Presence of at least 8 teeth

Exclusion Criteria:

• Smoking

• Diabetes Mellitus

• Pregnant females

• Patients who had undergone periodontal treatment within last 3 months

• Antibiotic therapy during last 3 months

• Other autoimmune diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of oral and dental medicine, Misr international university	Cairo		Egypt	12345

Sponsors and Collaborators

• Misr International University

Investigators

• Principal Investigator: Zainab Hafez, Lecturer, Lecturer, faculty of oral and dental medicine misr international university
• Principal Investigator: Yahia Hassan, Lecturer, Lecturer, faculty of oral and dental medicine misr international university
• Study Director: Shahinaz Al ashiry, asso.Prof, Associate Professor, faculty of oral and dental medicine misr international universit

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Misr International University
• ClinicalTrials.gov Identifier: NCT05706493
• Other Study ID Numbers: PER 3312007
• First Posted: Jan 31, 2023
• Last Update Posted: Jan 31, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Misr International University: periodontitis; rheumatoid arthritis; anti citrullinated protein antibodies; peptidyl arginine deminase enzyme; gingival crevicular fluid (GCF)
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Periodontitis; Periodontal Diseases

Study Results

No Results Posted as of Jan 31, 2023