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Periodontal Therapy in Patients With Rheumatoid Arthritis

NCT05502601 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-11-07

No results posted yet for this study

Summary

Aim: A prospective randomized, controlled clinical trial comparing two groups of a cohort of Rheumatoid Arthritis (RA) patients with periodontal disease will be carried out to identify if the effect of non-surgical periodontal therapy is a predictor of remission/ low disease activity (LDA)-remission.

Methods: 42 patients with RA and periodontitis from the RA Almenara cohort will be included (ACR 1987 and or ACR/EULAR 2010 criteria with more than 16 years old at diagnosis); those with \<6 teeth, current infections, cancer or oral precancerous lesions, diabetics, Sjogren's syndrome, use of antibiotics or drugs associated with dry mouth and dental surgery, will be excluded. Periodontal Disease was defined by the presence of periodontitis stage 3 or 4 with at least 2 non-adjacent teeth with insertion loss \>=5mm, probing depth \>=5mm and bleeding on probing according with the 2018 periodontitis diagnostic criteria.

Two RA patients groups will be follow up by monthly visits. Patients will be divided into two groups (intervention and no intervention treatment). PD treatment will be performed by a qualified periodontist. No intervention group will receive PD treatment after 6 month visit because ethical principles. Disease activity will be determined according with DAS 28index, Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) scores, C-reactive protein (CRP), the erythrocyte sedimentation rate (ESR), and rheumatoid factor levels will be registered before and after PD treatment (baseline, 3 and 6 months visits), and the differences between the groups will be analyzed and compared. Periodontal parameters including probing depth (PD), clinical attachment loss, and sulcus bleeding index (SBI) will be correlated with the factor levels.

Conditions

  • Arthritis, Rheumatoid
  • Periodontitis

Interventions

PROCEDURE

Non-surgical periodontal treatment

SRP will be performed under local anesthesia during a single, 2-hour, full-mouth ultrasonic and hand instrument debridement using curettes. Oral hygiene instructions (to educate and motivate patients to control the accumulation of plaque and calculus)

Sponsors & Collaborators

  • Universidad Científica del Sur

    collaborator OTHER

  • Federal University of Rio Grande do Sul

    lead OTHER

Principal Investigators

  • Andrea Vergara · Universidad Cientifica del Sur

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2024-05-01
Completion
2025-05-01

Countries

  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05502601 on ClinicalTrials.gov