Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003259-40-ES

Enrollment

120

Registered

2017-10-24

Start date

2018-01-04

Completion date

Unknown

Last updated

2021-07-05

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

Conditions

Patients with rheumatoid arthritis with high clinical activity and chronical peirodontitis moderate-severe. MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: amoxicilina Pharmaceutical Form: Buccal tablet INN or Proposed INN: AMOXICILLIN CAS Number: 26787-78-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To study if the intensive treatment in periodontitis could improve DAS-28(PCR), DAS-28(VSG) y SDAI, clear biomarkers in the active disease in rhematoid arthritis;Secondary Objective: 1. to Investigate if the intensive treatment of periodontitis could improve the immunological markers of disease, in patients with high clinical activity of RA. 2. To observe if there is a correlation between low detection of Porphyromonas gingivalis and Agreggatibacter actinomycetemcomitans, and citrullinated anti-peptide antibody titers (ACPA) in patients with high clinical activity of RA. 3. To analyze other possible demographic, environmental, educational and pharmacological factors that could influence the periodontal treatment and its impact in patients with high clinical activity of RA.;Primary end point(s): Disease activity: number of Painful joint (NAD), swollen joints (NAT), visual analog scale (physician and patient) EVA, CRP and ESR to calculate DAS28 (SVG), DAS28 (CRP) and SDAI activity indexes.;Timepoint(s) of evaluation of this end point: basal and at 30, 90, 180 and 365 days post treatment.	—

Measure

Time frame

Main Objective: To study if the intensive treatment in periodontitis could improve DAS-28(PCR), DAS-28(VSG) y SDAI, clear biomarkers in the active disease in rhematoid arthritis;Secondary Objective: 1. to Investigate if the intensive treatment of periodontitis could improve the immunological markers of disease, in patients with high clinical activity of RA. 2. To observe if there is a correlation between low detection of Porphyromonas gingivalis and Agreggatibacter actinomycetemcomitans, and citrullinated anti-peptide antibody titers (ACPA) in patients with high clinical activity of RA. 3. To analyze other possible demographic, environmental, educational and pharmacological factors that could influence the periodontal treatment and its impact in patients with high clinical activity of RA.;Primary end point(s): Disease activity: number of Painful joint (NAD), swollen joints (NAT), visual analog scale (physician and patient) EVA, CRP and ESR to calculate DAS28 (SVG), DAS28 (CRP) and SDAI activity indexes.;Timepoint(s) of evaluation of this end point: basal and at 30, 90, 180 and 365 days post treatment.

—

Secondary

Measure	Time frame
Secondary end point(s): Rheumatoid factor, ACPA, hemoglobin. P. gingivalis cepa ATCC 33277 y A. actinomycetemcomitans cepa DSM 8324;Timepoint(s) of evaluation of this end point: basal and at 30, 90, 180 and 365 days post treatment.	—

Countries

Spain

Contacts

Public ContactAna Aldea

UCICEC

aaldperh@gobiernodecanarias.org34922678117

Outcome results

None listed

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