Rheumatoid Arthritis (RA)NCT07844564
Effects of Nonsurgical Periodontal Treatment on GCF Calprotectin and IL-10 in Rheumatoid Arthritis
A study testing Non-surgical Periodontal Treatment in people with Rheumatoid Arthritis (RA) and Periodontitis, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the relationship between rheumatoid arthritis and periodontal health and examines the effects of nonsurgical periodontal treatment on clinical periodontal findings and gingival crevicular fluid biomarkers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis (RA), Periodontitis, Gingivitis
- What is being tested?
- Non-surgical Periodontal Treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jul 2025to 11 May 2026
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary participation in the study. Aged 18 to 65 years. For participants in the rheumatoid arthritis groups, diagnosis of rheumatoid arthritis at least 1 year before enrollment.
- For participants in the systemically healthy groups, absence of any systemic disease that may affect periodontal tissues.
- No periodontal treatment within the previous 6 months. No local or systemic antibiotic use within the previous 3 months. Never having smoked or having stopped smoking at least 2 years before enrollment.
- For participants in the periodontally healthy control groups, no history of periodontal disease and the presence of good oral hygiene.
Who cannot join
- Unwillingness to participate in the study. Age younger than 18 years or older than 65 years. Presence of any systemic disease other than rheumatoid arthritis that may affect periodontal tissues.
- Local or systemic antibiotic use within the previous 3 months. Periodontal treatment within the previous 6 months. Pregnancy or lactation. Use of medications that may affect gingival tissues, including calcium channel blockers, phenytoin, cyclosporine, or hormone replacement therapy.
- Receiving biological treatment for rheumatoid arthritis, such as anti-tumor necrosis factor therapy.
- Current smoking.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University Faculty of Dentistry
Samsun, Samsun, 55200
About this study
Official title: Effect of Nonsurgical Periodontal Treatment on Gingival Crevicular Fluid Calprotectin and IL-10 Levels in Patients With Rheumatoid Arthritis and Periodontitis
This study evaluates the relationship between rheumatoid arthritis and periodontal health and examines the effects of nonsurgical periodontal treatment on clinical periodontal findings and gingival crevicular fluid biomarkers. Participants with and without rheumatoid arthritis were classified according to periodontal status as periodontally healthy, gingivitis, or periodontitis. Clinical periodontal measurements and gingival crevicular fluid levels of calprotectin (MRP-8/14) and interleukin-10 (IL-10) were evaluated at baseline, 1 month, and 3 months. Disease Activity Score-28 (DAS28) was also evaluated in participants with rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis (RA), Periodontitis, Gingivitis
- Being tested
- Non-surgical Periodontal Treatment
- Keywords
- Nonsurgical Periodontal Treatment, Gingival Crevicular Fluid, Calprotectin, MRP-8/14, Interleukin-10, IL-10
- Medical subject headings
- Arthritis, Rheumatoid, Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical Periodontal TreatmentProcedure or surgery
Also called NSPT
The intervention consists of oral hygiene instructions, full-mouth scaling, and subgingival instrumentation and root planing where clinically indicated. It is administered to participants with periodontitis or gingivitis after baseline assessments. Periodontally healthy groups receive no periodontal treatment.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis with Rheumatoid Arthritis (P+RA | Experimental | Participants with rheumatoid arthritis and periodontitis receive non-surgical periodontal treatment. This arm includes 9 participants. Receives: Procedure: Non-surgical Periodontal Treatment |
| Systemically Healthy Participants with Periodontitis (P) | Experimental | Systemically healthy participants with periodontitis receive non-surgical periodontal treatment. This arm includes 9 participants. Receives: Procedure: Non-surgical Periodontal Treatment |
| Gingivitis with Rheumatoid Arthritis (G+RA) | Experimental | Participants with rheumatoid arthritis and gingivitis receive non-surgical periodontal treatment. This arm includes 9 participants. Receives: Procedure: Non-surgical Periodontal Treatment |
| Systemically Healthy Participants with Gingivitis (G) | Experimental | Systemically healthy participants with gingivitis receive non-surgical periodontal treatment. This arm includes 9 participants. Receives: Procedure: Non-surgical Periodontal Treatment |
| Periodontally Healthy Participants with Rheumatoid Arthritis (S+RA) | No intervention | Participants with rheumatoid arthritis and periodontal health receive no periodontal treatment and serve as a comparison group. This arm includes 9 participants. |
| Systemically Healthy Participants with Periodontal Health (S) | No intervention | Systemically and periodontally healthy participants receive no periodontal treatment and serve as a comparison group. This arm includes 9 participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gingival Crevicular Fluid Calprotectin (MRP-8/14) Levels
Gingival crevicular fluid calprotectin (MRP-8/14) levels were measured using an enzyme-linked immunosorbent assay (ELISA). Changes in calprotectin levels were evaluated over time and compared according to rheumatoid arthritis status and periodontal condition.
Measured: Baseline, 1 month, and 3 months
Secondary outcomes (8)
Change in Gingival Crevicular Fluid Interleukin-10 (IL-10) Levels
Gingival crevicular fluid interleukin-10 (IL-10) levels were measured using an enzyme-linked immunosorbent assay (ELISA). Changes in IL-10 levels were evaluated over time and compared according to rheumatoid arthritis status and periodontal condition.
Measured: Baseline, 1 month, and 3 months
Change in Probing Pocket Depth
Probing pocket depth was measured in millimeters using a periodontal probe as the distance from the gingival margin to the base of the periodontal pocket. Changes were evaluated over time according to rheumatoid arthritis status and periodontal condition.
Measured: Baseline, 1 month, and 3 months
Change in Clinical Attachment Level
Clinical attachment level was measured in millimeters using a periodontal probe as the distance from the cementoenamel junction to the base of the periodontal pocket. Changes were evaluated over time according to rheumatoid arthritis status and periodontal condition.
Measured: Baseline, 1 month, and 3 months
Change in Bleeding on Probing
Bleeding on probing was recorded as present or absent following gentle periodontal probing and expressed as the percentage of sites with bleeding. Changes were evaluated over time according to rheumatoid arthritis status and periodontal condition.
Measured: Baseline, 1 month, and 3 months
Change in Plaque Index
Plaque accumulation was assessed using the Plaque Index. Changes in plaque scores were evaluated over time according to rheumatoid arthritis status and periodontal condition.
Measured: Baseline, 1 month, and 3 months
Change in Gingival Index
Gingival inflammation was assessed using the Gingival Index. Changes in gingival index scores were evaluated over time according to rheumatoid arthritis status and periodontal condition.
Measured: Baseline, 1 month, and 3 months
Change in Gingival Crevicular Fluid Volume
Gingival crevicular fluid volume was measured using Periopaper strips and a calibrated Periotron 8000 device. Changes in gingival crevicular fluid volume were evaluated over time according to rheumatoid arthritis status and periodontal condition.
Measured: Baseline, 1 month, and 3 months
Change in Disease Activity Score-28 (DAS28)
Disease activity was evaluated in participants with rheumatoid arthritis using the Disease Activity Score-28 (DAS28). Changes in DAS28 scores were assessed following nonsurgical periodontal treatment.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start17 Jul 2025
- Primary completion11 May 2026
- Study completion11 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songül Bingöl, Ondokuz Mayıs University
- Investigators
- Songül Bingöl, DDS, Principal investigator, Ondokuz Mayis University, Faculty of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844564
- Sponsor's protocol ID
- OMU-KAEK-2025-253
- Other IDs
- 6065
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nonsurgical Periodontal Treatment on Gingival Crevicular Fluid Calprotectin and IL-10 Levels in Patients With Rheumatoid Arthritis and Periodontitis
- ClinicalTrials.gov ID
- NCT07844564
- Acronym / sponsor ID
- OMU-KAEK-2025-253
- Conditions
- Rheumatoid Arthritis (RA), Periodontitis, Gingivitis
- Keywords
- Nonsurgical Periodontal Treatment, Gingival Crevicular Fluid, Calprotectin, MRP-8/14, Interleukin-10, IL-10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 28 Sep 2026 (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.
This study evaluates the relationship between rheumatoid arthritis and periodontal health and examines the effects of nonsurgical periodontal treatment on clinical periodontal findings and gingival crevicular fluid biomarkers. Participants with and without rheumatoid arthritis were classified according to periodontal status as periodontally healthy, gingivitis, or periodontitis. Clinical periodontal measurements and gingival crevicular fluid levels of calprotectin (MRP-8/14) and interleukin-10 (IL-10) were evaluated at baseline, 1 month, and 3 months. Disease Activity Score-28 (DAS28) was also evaluated in participants with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Periodontitis with Rheumatoid Arthritis (P+RA | Experimental | Procedure: Non-surgical Periodontal TreatmentParticipants with rheumatoid arthritis and periodontitis receive non-surgical periodontal treatment. This arm includes 9 participants. |
| Systemically Healthy Participants with Periodontitis (P) | Experimental | Procedure: Non-surgical Periodontal TreatmentSystemically healthy participants with periodontitis receive non-surgical periodontal treatment. This arm includes 9 participants. |
| Gingivitis with Rheumatoid Arthritis (G+RA) | Experimental | Procedure: Non-surgical Periodontal TreatmentParticipants with rheumatoid arthritis and gingivitis receive non-surgical periodontal treatment. This arm includes 9 participants. |
| Systemically Healthy Participants with Gingivitis (G) | Experimental | Procedure: Non-surgical Periodontal TreatmentSystemically healthy participants with gingivitis receive non-surgical periodontal treatment. This arm includes 9 participants. |
| Periodontally Healthy Participants with Rheumatoid Arthritis (S+RA) | No intervention | –Participants with rheumatoid arthritis and periodontal health receive no periodontal treatment and serve as a comparison group. This arm includes 9 participants. |
| Systemically Healthy Participants with Periodontal Health (S) | No intervention | –Systemically and periodontally healthy participants receive no periodontal treatment and serve as a comparison group. This arm includes 9 participants. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntary participation in the study. Aged 18 to 65 years. For participants in the rheumatoid arthritis groups, diagnosis of rheumatoid arthritis at least 1 year before enrollment.
- For participants in the systemically healthy groups, absence of any systemic disease that may affect periodontal tissues.
- No periodontal treatment within the previous 6 months. No local or systemic antibiotic use within the previous 3 months. Never having smoked or having stopped smoking at least 2 years before enrollment.
- For participants in the periodontally healthy control groups, no history of periodontal disease and the presence of good oral hygiene.
Key exclusion criteria (4 listed)
- Unwillingness to participate in the study. Age younger than 18 years or older than 65 years. Presence of any systemic disease other than rheumatoid arthritis that may affect periodontal tissues.
- Local or systemic antibiotic use within the previous 3 months. Periodontal treatment within the previous 6 months. Pregnancy or lactation. Use of medications that may affect gingival tissues, including calcium channel blockers, phenytoin, cyclosporine, or hormone replacement therapy.
- Receiving biological treatment for rheumatoid arthritis, such as anti-tumor necrosis factor therapy.
- Current smoking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-surgical Periodontal TreatmentAlso: NSPTThe intervention consists of oral hygiene instructions, full-mouth scaling, and subgingival instrumentation and root planing where clinically indicated. It is administered to participants with periodontitis or gingivitis after baseline assessments. Periodontally healthy groups receive no periodontal treatment. | Procedure or surgery | Gingivitis with Rheumatoid Arthritis (G+RA), Periodontitis with Rheumatoid Arthritis (P+RA, Systemically Healthy Participants with Gingivitis (G), Systemically Healthy Participants with Periodontitis (P) |
Primary outcome
Change in Gingival Crevicular Fluid Calprotectin (MRP-8/14) Levels
Time frame: Baseline, 1 month, and 3 months
Gingival crevicular fluid calprotectin (MRP-8/14) levels were measured using an enzyme-linked immunosorbent assay (ELISA). Changes in calprotectin levels were evaluated over time and compared according to rheumatoid arthritis status and periodontal condition.
8 secondary outcomes
Change in Gingival Crevicular Fluid Interleukin-10 (IL-10) Levels
Time frame: Baseline, 1 month, and 3 months
Change in Probing Pocket Depth
Time frame: Baseline, 1 month, and 3 months
Change in Clinical Attachment Level
Time frame: Baseline, 1 month, and 3 months
Change in Bleeding on Probing
Time frame: Baseline, 1 month, and 3 months
Change in Plaque Index
Time frame: Baseline, 1 month, and 3 months
Change in Gingival Index
Time frame: Baseline, 1 month, and 3 months
Change in Gingival Crevicular Fluid Volume
Time frame: Baseline, 1 month, and 3 months
Change in Disease Activity Score-28 (DAS28)
Time frame: Baseline and 3 months
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 28 Sep 2026.
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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.
Songül Bingöl, DDS principal investigator
Ondokuz Mayis University, Faculty of Dentistry, Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical Periodontal Treatment in people with Rheumatoid Arthritis (RA) and Periodontitis, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 4 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 28 Sep 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 Turkey (Türkiye). 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?
Change in Gingival Crevicular Fluid Calprotectin (MRP-8/14) Levels (time frame: Baseline, 1 month, and 3 months). 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 28 Sep 2026.