NCT07844564

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

September 22, 2026

Last Update Submit

September 22, 2026

Conditions

Rheumatoid Arthritis (RA)PeriodontitisGingivitis

Keywords

Nonsurgical Periodontal TreatmentGingival Crevicular FluidCalprotectinMRP-8/14Interleukin-10IL-10

Outcome Measures

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.

    Baseline, 1 month, and 3 months

Secondary Outcomes (8)

  • Change in Gingival Crevicular Fluid Interleukin-10 (IL-10) Levels

    Baseline, 1 month, and 3 months

  • Change in Probing Pocket Depth

    Baseline, 1 month, and 3 months

  • Change in Clinical Attachment Level

    Baseline, 1 month, and 3 months

  • Change in Bleeding on Probing

    Baseline, 1 month, and 3 months

  • Change in Plaque Index

    Baseline, 1 month, and 3 months

  • +3 more secondary outcomes

Study Arms (6)

Periodontitis with Rheumatoid Arthritis (P+RA

EXPERIMENTAL

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

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.

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.

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.

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.

Interventions

Non-surgical Periodontal TreatmentPROCEDURE

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
Gingivitis with Rheumatoid Arthritis (G+RA)Periodontitis with Rheumatoid Arthritis (P+RASystemically Healthy Participants with Gingivitis (G)Systemically Healthy Participants with Periodontitis (P)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University Faculty of Dentistry

Samsun, Samsun, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, RheumatoidPeriodontitisGingivitis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Study Officials

  • Songül Bingöl, DDS

    Ondokuz Mayis University, Faculty of Dentistry, Department of Periodontology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, Department of Periodontology, Faculty of Dentistry

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 28, 2026

Study Start

July 17, 2025

Primary Completion

May 11, 2026

Study Completion

May 11, 2026

Last Updated

September 28, 2026

Record last verified: 2026-09

Locations

TU(1)