Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
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2020
INTERVENTION: Rheumatoid arthritis is diagnosed according to ACR/EULAR 2010 (American College of Rheumatology/ European League Against Rheumatism). The periodontal condition is detected by a periodontist following the criteria of Machtei, 1992. Both groups are treated with conventional regimens. The assignment of each patient to a study group is determined by means of a randomization technique using sealed and numbered envelopes; details of the sequence were concealed from all clinicians who participated in the study. A staff member not involved in the subsequent experimentation generates a random allocation sequence, in a 1:1 ratio, for distribution of the patients to one of the two groups. The control group only receive oral hygiene instruction while the treatment group receive an advanced periodontal treatment intervention, including supragingival scaling and root planning, reviewing effect after 3 and 6 months respectively, and retreating after each evaluation. The study team consists of a periodontist recording periodontal indices, a rheumatologist assessing swollen and tender joints, and an assistant. Researchers treat periodontitis for RA patients, not involving in periodontal as well as the joint examination. Team members are trained by experts before the study, achieving consistency from 80% to 90.4%. The disease activity score 28 based on CRP (DAS28‐CRP), disease activity classification, rheumatoid factor (RF), erythrocyte sedimentation rate (ESR) and reactive Protein ‐ C (CRP) are recorded and monitored at baseline, 3 and 6 months later after undergoing periodontal treatment. CONDITION: Periodontal disease and rheumatoid arthritis (RA) ; Oral Health PRIMARY OUTCOME: ; 1. Periodontal indicators (plaque index (PlI), gingival index (GI), %BOP (percentage of sites with bleeding on probing), probing pocket depth (PPD), and clinical attachment loss (CAL)) measured at six positions in all teeth at baseline, 3 and 6 months; 2. Pain measured using the visual analogue score (VAS) at baseline, 3 and 6 months; 3. Pain and swelling of 28 joints assessed using DAS28‐CRP activity score at baseline, 3 and 6 months; SECONDARY OUTCOME: Serum concentrations of rheumatoid factor (RF) and CRP measured with a latex particle‐enhanced method at baseline, 3 and 6 months INCLUSION CRITERIA: 1. Adult patients diagnosed with active RA and PD from previous cross‐sectional descriptive study 1.1. Rheumatoid arthritis was diagnosed according to ACR/EULAR 2010 1.2. The periodontal condition was detected by a periodontist following the criteria of Machtei, 1992
Epistemonikos ID: 71147f4cb7e29863db47ec833225b20b0057d162
First added on: Aug 24, 2024