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

• Register: EUCTR
• Last refreshed on: 5 July 2021
• Main ID: EUCTR2017-003259-40-ES
• Date of registration: 24/10/2017
• Prospective Registration: Yes
• Primary sponsor: Dra Beatriz Lozano-Hospital Universitario de Canarias
• Public title: Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial.
• Scientific title: Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial.
• Date of first enrolment: 04/01/2018
• Target sample size: 120
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003259-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: two sessions of tartrectomy and 15ml PerioAId buccal solution 60 seconds.; Number of treatment arms in the trial: 60
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Spain

Contacts

• Name: Ana Aldea
• Affiliation: UCICEC

• Name: Ana Aldea
• Affiliation: UCICEC

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

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

Intervention(s)

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: 500-

Product Name: metronidazol
Pharmaceutical Form: Buccal tablet
INN or Proposed INN: METRONIDAZOLE
Other descriptive name: metronidazol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-

Primary Outcome(s)

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.

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

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 Outcome(s)

Timepoint(s) of evaluation of this end point: basal and at 30, 90, 180 and 365 days post treatment.

Secondary end point(s): Rheumatoid factor, ACPA, hemoglobin.
P. gingivalis cepa ATCC 33277 y
A. actinomycetemcomitans cepa DSM 8324

Secondary ID(s)

AREP2017

Source(s) of Monetary Support

Fundación Canaria de Investigación Sanitaria

Universidad Complutense de Madrid

Ethics review

Status: Approved
Approval date: 21/12/2017
Contact: