Periodontal DiseasesNCT05706493
Association Between Periodontitis and the Level of Anti-citrullinated Protein Antibodies in Rheumatoid Arthritis
An observational study of Periodontal Diseases and Rheumatoid Arthritis, run by Misr International University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Diseases, Rheumatoid Arthritis
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Feb 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatoid patients
Who may be able to join
- Rheumatoid patients fulfilling the ACR criteria for the classification of RA
- 18 years
- Both genders
- Presence of at least 8 teeth
Who cannot join
- Smoking
- Diabetes Mellitus
- Pregnant females
- Patients who had undergone periodontal treatment within last 3 months
- Antibiotic therapy during last 3 months
- Other autoimmune diseases
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of oral and dental medicine, Misr international university
Cairo, 12345
About this study
Official title: Association Between Severity of Periodontitis and the Level of Anti-citrullinated Protein Antibodies (ACPAs) in Rheumatoid Arthritis Patients
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 and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (RA) patients
Read the 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 and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (RA) patients Materials and Methods: a total of 62 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 . Assessment of ACPAs will be quantified using enzyme-linked immunoassay (ELISA) as the primary outcome Assessment of 2ry outcomes includes clinical periodontal and RA parameters
- Conditions
- Periodontal Diseases, Rheumatoid Arthritis
- Keywords
- periodontitis, rheumatoid arthritis, anti citrullinated protein antibodies, peptidyl arginine deminase enzyme, gingival crevicular fluid (GCF)
- Medical subject headings
- Periodontal Diseases, Arthritis, Rheumatoid, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| rhematoid arthritis patients | assessment of different periodontal parameters and gingival crevicular fluid sampling will be done |
What is being measured
The primary outcome is the main question the study is designed to answer.
the level of anti-citrullinated protein antibodies (ACPAs)
assessment of the level of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid
Measured: Baseline
Secondary outcomes (2)
Clinical attachment Loss
measuring the distance from the cemento enamel junction to the base of the pocket in mm
Measured: Baseline
Probing depth
measuring the distance from the gingival margin to the base of the pocket in mm
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Mar 2024
- Primary completion1 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zainab Hafez, Lecturer, Principal investigator, Lecturer, faculty of oral and dental medicine misr international universityYahia Hassan, Lecturer, Principal investigator, Lecturer, faculty of oral and dental medicine misr international universityShahinaz Al ashiry, asso.Prof, Study director, Associate Professor, faculty of oral and dental medicine misr international universit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706493
- Sponsor's protocol ID
- PER 3312007
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Severity of Periodontitis and the Level of Anti-citrullinated Protein Antibodies (ACPAs) in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT05706493
- Acronym / sponsor ID
- PER 3312007
- Conditions
- Periodontal Diseases, Rheumatoid Arthritis
- Keywords
- periodontitis, rheumatoid arthritis, anti citrullinated protein antibodies, peptidyl arginine deminase enzyme, gingival crevicular fluid (GCF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (RA) patients Materials and Methods: a total of 62 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 . Assessment of ACPAs will be quantified using enzyme-linked immunoassay (ELISA) as the primary outcome Assessment of 2ry outcomes includes clinical periodontal and RA parameters
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rhematoid arthritis patients | – | –assessment of different periodontal parameters and gingival crevicular fluid sampling will be done |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid patients
Key inclusion criteria (4 listed)
- Rheumatoid patients fulfilling the ACR criteria for the classification of RA
- Both genders
- Presence of at least 8 teeth
Key exclusion criteria (6 listed)
- Smoking
- Diabetes Mellitus
- Pregnant females
- Patients who had undergone periodontal treatment within last 3 months
- Antibiotic therapy during last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the level of anti-citrullinated protein antibodies (ACPAs)
Time frame: Baseline
assessment of the level of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid
2 secondary outcomes
Clinical attachment Loss
Time frame: Baseline
Probing depth
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zainab Hafez, Lecturer principal investigator
Lecturer, faculty of oral and dental medicine misr international university
Yahia Hassan, Lecturer principal investigator
Lecturer, faculty of oral and dental medicine misr international university
Shahinaz Al ashiry, asso.Prof study director
Associate Professor, faculty of oral and dental medicine misr international universit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Rheumatoid Arthritis, run by Misr International University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the level of anti-citrullinated protein antibodies (ACPAs) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.