Rheumatoid arthritis, Inflammation, Focal Infection Dental
Conditions
Interventions
A triple blind clinical trial, randomized controlled parallel-group will be developed. Experimental group: 48 patients with rheumatoid arthritis of both sexes who require tooth extraction will be divi
Drug
Procedure/surgery
E06.892
Sponsors
Universidade Federal do Ceará
Hospital Universitário Walter Cantídio
Hospital Geral de Fortaleza
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Healthy volunteers and subjects with rheumatoid arthritis who make use of inhibitors of TNF-alpha and methotrexate.Participants with aged 18 to 75 years. Patients that signed the IC (Informed Consent)and requiring simple extractions, exhibiting in blood tests (INR- international normalized ratio less than 2.5 platelet count above the 30.000; Count leukocytes above the 2.000 per mm³ and fasting glucose lower than 126 mg/dL). This study aims to enroll about 72 patients.
Exclusion criteria
Exclusion criteria: Patients that used antibiotics in the last 15 days. Patients allergic to Amoxicillin (experimental group).Patients with dental infection(periodontal abscess or periapical abscess).Patients with pre-existing infection. Patients that used additional immunosuppressive medication and patients who not attended the scheduled follow and/or do not follow the instructions of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will conduct different schemes with amoxicillin (prophylaxis and coverage) to prevent post-extraction infections in rheumatoid arthritis patients treated with anti-TNF alpha. It is expected to identify all the groups will not develop post-extraction infection (0% infection) and that there is no difference between the groups (n = 24; prophylaxis with amoxicillin); B (n = 24, with coverage amoxicillin) and control (n = 24, without medication). Thus using antibiotic prophylaxis be rationally most suitable for these patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additionally, evaluations of clinical parameters (pain, inflammation and scarring) will be in patients submitted to different management schemes with amoxicillin (prophylaxis and coverage) and control group, after performing the extractions in rheumatoid arthritis patients treated with anti-TNF alpha. It is expected to identify that there is no difference between groups A (n = 24; prophylaxis with amoxicillin); B (n = 24, with coverage amoxicillin) and control (n = 24, without medication) compared to the percentage of clinical events of pain, inflammation and scarring that will be evaluated. | — |
Countries
Brazil
Contacts
Public ContactMário Lima Mota
Universidade Federal do Ceará
Outcome results
None listed