Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial.
- Conditions
- Patients with rheumatoid arthritis with high clinical activity and chronical peirodontitis moderate-severe.MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2017-003259-40-ES
- Lead Sponsor
- Dra Beatriz Lozano-Hospital Universitario de Canarias
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
Patients more than 18 years with RA (ACR/EULAR 2010 criteria) with high clinical activity defined SG) y/o DAS28 (PCR)> 5,1 y SDAI > 26.
Ptients with moderate-severe chronic peridontitis (Level 2 Tonetti 2005)
Paients with 8 teeth and more than 8 teeth.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
Non-surgical periodontal treatment during the previous 6 months
Oral surgical treatment during the previous 12 months
Antibiotic treatment in the previous 6 months
Pre-treatment with cyclosporin-A, calcium channel blockers or phenytoin.
Requirement of antibiotic prophylaxis prior to oral examination.
Patients with RA who carry any prosthetic joint replacement.
Patients who collaborate and who are able to sign informed consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method