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CompletedNCT07844564Updated Sep 28, 2026

Effects of Nonsurgical Periodontal Treatment on GCF Calprotectin and IL-10 in Rheumatoid Arthritis

An interventional study of Non-surgical Periodontal Treatment in Rheumatoid Arthritis (RA), Periodontitis and Gingivitis, sponsored by Ondokuz Mayıs University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jul 2025, registered Sep 2026).
Updated Sep 28, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Rheumatoid Arthritis (RA)
  • Periodontitis
  • Gingivitis

Keywords

  • Nonsurgical Periodontal Treatment
  • Gingival Crevicular Fluid
  • Calprotectin
  • MRP-8/14
  • Interleukin-10
  • IL-10
03

In context

Arthritis, Rheumatoid

2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.

This study's enrollment of 54 is below the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Ondokuz Mayıs University is the lead sponsor of 262 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Periodontitis with Rheumatoid Arthritis (P+RA

    Participants with rheumatoid arthritis and periodontitis receive non-surgical periodontal treatment. This arm includes 9 participants.

    Procedure: Non-surgical Periodontal Treatment

  • Experimental
    Systemically Healthy Participants with Periodontitis (P)

    Systemically healthy participants with periodontitis receive non-surgical periodontal treatment. This arm includes 9 participants.

    Procedure: Non-surgical Periodontal Treatment

  • Experimental
    Gingivitis with Rheumatoid Arthritis (G+RA)

    Participants with rheumatoid arthritis and gingivitis receive non-surgical periodontal treatment. This arm includes 9 participants.

    Procedure: Non-surgical Periodontal Treatment

  • Experimental
    Systemically Healthy Participants with Gingivitis (G)

    Systemically healthy participants with gingivitis receive non-surgical periodontal treatment. This arm includes 9 participants.

    Procedure: Non-surgical Periodontal Treatment

  • No intervention
    Periodontally Healthy Participants with Rheumatoid Arthritis (S+RA)

    Participants with rheumatoid arthritis and periodontal health receive no periodontal treatment and serve as a comparison group. This arm includes 9 participants.

  • No intervention
    Systemically Healthy Participants with Periodontal Health (S)

    Systemically and periodontally healthy participants receive no periodontal treatment and serve as a comparison group. This arm includes 9 participants.

Interventions

  • ProcedureNon-surgical Periodontal Treatment

    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.

    Also known as: NSPT

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 1 month, and 3 months

Secondary outcomes

  1. 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.

    Time frame: Baseline, 1 month, and 3 months

  2. 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.

    Time frame: Baseline, 1 month, and 3 months

  3. 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.

    Time frame: Baseline, 1 month, and 3 months

  4. 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.

    Time frame: Baseline, 1 month, and 3 months

  5. 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.

    Time frame: Baseline, 1 month, and 3 months

  6. 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.

    Time frame: Baseline, 1 month, and 3 months

  7. 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.

    Time frame: Baseline, 1 month, and 3 months

  8. 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.

    Time frame: Baseline and 3 months

07

Study locations

1 site
  • Ondokuz Mayis University Faculty of Dentistry
    Samsun, Samsun 55200, Turkey (Türkiye)
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07844564
Lead sponsor
Ondokuz Mayıs University
Responsible party
Songül Bingöl (Research Assistant, Department of Periodontology, Faculty of Dentistry, Ondokuz Mayıs University) — Principal investigator
First posted
Sep 28, 2026
Start date
Jul 17, 2025
Primary completion
May 11, 2026
Completion
May 11, 2026
Last update
Sep 28, 2026

Study contacts

Songül Bingöl, DDS
principal investigator · Ondokuz Mayis University, Faculty of Dentistry, Department of Periodontology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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