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A Multicenter Randomized Clinical Trial to Evaluate the Effect of Non-surgical Periodontal Therapy on Clinical Parameters in Subjects with Rheumatoid arthritis and severe Periodontitis

A Multicenter Randomized Clinical Trial to Evaluate the Effect of Non-surgical Periodontal Therapy on Clinical Parameters in Subjects with Rheumatoid arthritis and severe Periodontitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084296
Enrollment
Unknown
Registered
2024-05-14
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic periodontitis

Interventions

Sponsors

Peking University School and Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Men or women aged = 18 years old; 2. Simultaneously diagnosed with rheumatoid arthritis (2010ACR/EULAR diagnostic criteria) and stage III/IV periodontitis (2018 new classification); 3. In the active phase of the disease, with a DAS28 score of = 3.2; 4. Within 3 months prior to the screening visit, the medication, dosage, or formula for RA treatment should remain largely unchanged; 5. There are at least 15 natural teeth remaining in the mouth, and at least 4 teeth meet the following criteria: clinical attachment level (CAL) = 6 mm or periodontal probing depth (PD) = 5 mm; 6. Previously without systematic periodontal treatment; 7. Informed consent of the subjects.

Exclusion criteria

Exclusion criteria: 1. Have one or more infectious diseases, such as AIDS, hepatitis, infectious mononucleosis; 2. Suffering from known kidney disease (creatinine clearance rate<60ml/min) or liver disease; 3. Have unbalanced diabetes; 4. There is a risk of endocarditis; 5. Subjects with permanent pacemakers; 6. Subjects receiving antithrombotic treatment; 7. For women: pregnant or planning to conceive, or breastfeeding; 8. Subjects with chronic diseases who require long-term or intermittent use of antibiotics, and patients who receive medication known to affect periodontal status are also excluded (amoxicillin, etc.); 9. Subjects who have used any systemic or local immunosuppression (including steroids) within the past 6 months; 10. At least one of the following situations occurs: acute oral infection, acute oral pain (including pulpitis), suspected oral mucosal lesions, severe oral inflammation unrelated to periodontal disease, or ongoing orthodontic treatment; 11. Individuals with contraindications to local dental anesthesia; 12. Subjects who have serious difficulties in understanding written and spoken French; 13. Other circumstances that may affect the conduct of this study.

Design outcomes

Primary

MeasureTime frame
DAS28(CRP): 28-Joint Disease Activity Score (C reactive protein);

Secondary

MeasureTime frame
ACR20: American College of Rheumatology 20;HAQ-DI: Health Assessment Questionnaire Disability Index;

Countries

China

Contacts

Public ContactXU MINGMING

Peking University School and Hospital of Stomatology

anniemmx@126.com+86 139 1103 2100

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026