RCT: Evaluating the Effect of Oral Care for Periodontitis in Rhematoid Arthritis Patients in Uganda
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Makerere University
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- change in Disease Activity score of 28 joints
Study Overview
Brief Summary
this will be an RCT. to determine if non-surgical treatment for periodontitis can improve the disease activity score in 28 joints of rheumatoid arthritis in an African setting. Rheumatoid arthritis patients with periodontal disease will be randomised into an immediate intervention arm and a delayed intervention arm and both groups will be followed for two three monthly periods
Detailed Description
- RESEARCH QUESTIONS
- What is the prevalence of periodontitis among rthematoid arthritis patients attending the Mulago rheumatology clinic?
- Does non-surgical treatment for periodontitis improve the disease activity score in 28 joints of rheumatoid arthritis in this local setting?
- Problem statement It has been shown that intervention with nonsurgical treatment of periodontitis improved the periodontal condition of patients with periodontitis and RA, with beneficial effects upon the clinical and laboratory test parameters, disease activity scores in 28 joints (DAS28) and erythrocyte sedimentation rate (ESR). However, all the studies included in the reviews involved small samples sizes and follow-up periods of less than 6 months. And locally to our knowledge there is currently no published information looking at the role of periodontal disease among Ugandans with rheumatoid arthritis.
- METHODS Objective 1 will be addressed with a cross sectional study design while objective 2 will be a randomized control intervention on a fresh sample of patients from the clinic who will be randomly assigned using computer generated random numbers.
Population : To address the objective 1 a total sample size of 146 randomly selected study participants.
For objective 2 the target sample size of 304 individuals or 152 individuals per group.
Procedures: On arrival to the dental clinic, the selected and previously consented participants will undergo a standardized interview. This will be followed by an oral examination to assess for: registration of plaque, bleeding on probing, probing depth and followed with the calculation of the Periodontal inflamed surface area score and clinical attachment loss, pick crevicular fluid using paper point for follow-up confirmatory polymerase chain reactions (PCR), quantification with quantitative real-time PCR (QPCR) experiments for P. gingivalis. At the end of the examination a peripheral blood sample will be obtained for: erythrocyte sedimentation rate to be factored in the determination of DAS 28 score. The remaining blood sample will be stored in the department of Anatomy for further studies latter pertaining to PD and RA.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
the participants will not know the arm of the study they are in.
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older (of either gender).
- •RA diagnosed at least 2 year before V
- •DAS28 score between 3.2 and 5.1 during the month preceding V
- •No change in medication, dose, or formulation in RA treatment during the 3 months preceding V
- •Available for all study visits over 6 months
- •Presence of at least six natural teeth.
- •Ability to give written informed consent.
- •Having Periodontal Disease
Exclusion Criteria
- •Chronic disorder requiring chronic or intermittent use of antibiotics.
- •Known hypersensitivity to chlorhexidine digluconate.
- •Participation in another intervention study.
- •Known contraindications to both amoxicillin and clindamycin.
- •Known contraindications to dental local anesthetic.
- •Pregnancy or lactation or intent to become pregnant
Arms & Interventions
Scaling and polishing plus oral hygiene instruction
This arm will contain RA participants with PD who will continue with their treatment for RA and also receive the intervention of scaling and polishing plus oral hygiene instructions
Intervention: Scaling and polishing (Procedure)
Scaling and polishing plus oral hygiene instruction
This arm will contain RA participants with PD who will continue with their treatment for RA and also receive the intervention of scaling and polishing plus oral hygiene instructions
Intervention: oral hygiene instructions (Other)
only oral hygiene instructions
This arm will contain rheumatoid arthritis (RA) participants with periodontitis who will continue with their treatment for (RA) and also receive only oral hygiene instructions
Intervention: oral hygiene instructions (Other)
Outcomes
Primary Outcomes
change in Disease Activity score of 28 joints
Time Frame: Two three monthly follow ups
≤ 3.2- inactive, \>3.2 but ≤ 5.1 - moderate and \> 5.1- very active
Secondary Outcomes
- change in clinical attachment loss(Two three monthly follow ups)