Clinical trial NCT05706493: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Rheumatoid Arthritis
Keywords: periodontitis
rheumatoid arthritis
anti citrullinated protein antibodies
peptidyl arginine deminase enzyme
gingival crevicular fluid (GCF)
Lead sponsor: Misr International University
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 curettes
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the level of anti-citrullinated protein antibodies (ACPAs)
timeFrame: at baseline and 3 months
Secondary outcomes:
measure: Change in Clinical attachment Loss
timeFrame: at baseline and 3 months
measure: Change in Probing depth
timeFrame: at baseline and 3 months
measure: Change in Plaque index (PI)
timeFrame: at baseline and 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of oral and dental medicine, Misr international university
Study officials:
affiliation: Lecturer, faculty of oral and dental medicine misr international university
name: Zainab Hafez, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer, faculty of oral and dental medicine misr international university
name: Yahia Hassan, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor, faculty of oral and dental medicine misr international universit
name: Shahinaz Al ashiry, asso.Prof
role: STUDY_DIRECTOR
References: