Clinical trial NCT03513263: Effect of Periodontal Care on Rhematoid Arthritis in Uganda
Official title: RCT: Evaluating the Effect of Oral Care for Periodontitis in Rhematoid Arthritis Patients in Uganda
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Periodontal Diseases
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: scaling and polishing plus oral hygiene instructions will be provided for the intervention arm while only oral hygiene instruction will be provided for the control arm. At the end of the six month follow up the control arm will also be provided with scaling and polishing.
Primary purpose: TREATMENT

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: 1. 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?
2. 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.
3. 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.

Objective 2 RCT study Participants will be randomized into an immediate intervention arm and a delayed intervention arm.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older (of either gender).
2. RA diagnosed at least 2 year before V0.
3. DAS28 score between 3.2 and 5.1 during the month preceding V0.
4. No change in medication, dose, or formulation in RA treatment during the 3 months preceding V0.
5. Available for all study visits over 6 months
6. Presence of at least six natural teeth.
7. Ability to give written informed consent.
8. Having Periodontal Disease

Exclusion Criteria:

1. Chronic disorder requiring chronic or intermittent use of antibiotics.
2. Known hypersensitivity to chlorhexidine digluconate.
3. Participation in another intervention study.
4. Known contraindications to both amoxicillin and clindamycin.
5. Known contraindications to dental local anesthetic.
6. Pregnancy or lactation or intent to become pregnant

Primary outcomes:
measure: change in Disease Activity score of 28 joints
timeFrame: Two three monthly follow ups
Secondary outcomes:
measure: change in clinical attachment loss
timeFrame: Two three monthly follow ups
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Rheumatology clinic, medical outpatient department, Mulago national referral hospital and the Uganda
Study officials:
affiliation: MakCHS
name: Ian Munabi, PhD
role: STUDY_DIRECTOR
References: