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

Primary Purpose

Periodontal Diseases, Rheumatoid Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Non surgical periodontal treatment
Sponsored by
Misr International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring periodontitis, rheumatoid arthritis, anti citrullinated protein antibodies, peptidyl arginine deminase enzyme, gingival crevicular fluid (GCF)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of oral and dental medicine, Misr international universityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Non-surgical periodontal treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Clinical attachment Loss
measuring the distance from the cemento enamel junction to the base of the pocket in mm
Change in Probing depth
measuring the distance from the gingival margin to the base of the pocket in mm
Change in Plaque index (PI)
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

Full Information

First Posted
January 23, 2023
Last Updated
October 17, 2023
Sponsor
Misr International University
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1. Study Identification

Unique Protocol Identification Number
NCT05706493
Brief Title
Association Between Periodontitis and the Level of Anti-citrullinated Protein Antibodies in Rheumatoid Arthritis
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Misr International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Rheumatoid Arthritis
Keywords
periodontitis, rheumatoid arthritis, anti citrullinated protein antibodies, peptidyl arginine deminase enzyme, gingival crevicular fluid (GCF)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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 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
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-surgical periodontal treatment
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Non surgical periodontal treatment
Intervention Description
Non-surgical periodontal treatment will be performed using ultrasonic scaler and subgingival curettes
Primary Outcome Measure Information:
Title
Change in the level of anti-citrullinated protein antibodies (ACPAs)
Description
assessment of the level of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid
Time Frame
at baseline and 3 months
Secondary Outcome Measure Information:
Title
Change in Clinical attachment Loss
Description
measuring the distance from the cemento enamel junction to the base of the pocket in mm
Time Frame
at baseline and 3 months
Title
Change in Probing depth
Description
measuring the distance from the gingival margin to the base of the pocket in mm
Time Frame
at baseline and 3 months
Title
Change in Plaque index (PI)
Description
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
Time Frame
at baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zainab Hafez, Lecturer
Phone
+01221334637
Email
zeinab.hafez@miuegypt.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Yahia Hasssan, Lecturer
Email
yahia.hassan@miuegypt.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zainab Hafez, Lecturer
Organizational Affiliation
Lecturer, faculty of oral and dental medicine misr international university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yahia Hassan, Lecturer
Organizational Affiliation
Lecturer, faculty of oral and dental medicine misr international university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shahinaz Al ashiry, asso.Prof
Organizational Affiliation
Associate Professor, faculty of oral and dental medicine misr international universit
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of oral and dental medicine, Misr international university
City
Cairo
ZIP/Postal Code
12345
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zainab Hafez, Lecturer
Phone
+201221334637
Email
zeinab.hafez@miuegypt.edu.eg
First Name & Middle Initial & Last Name & Degree
Yahia amer, Lecturer
Email
yahia.hassan@miuegypt.edu.eg
First Name & Middle Initial & Last Name & Degree
Zainab Hafez, PhD
First Name & Middle Initial & Last Name & Degree
Yahia Hassan, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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