RCT: Evaluating the Effect of Oral Care for Periodontitis in Rhematoid Arthritis Patients in Uganda
试验速览
- 阶段
- 不适用
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- change in Disease Activity score of 28 joints
研究概览
简要总结
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
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
the participants will not know the arm of the study they are in.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: 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
干预措施: 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
干预措施: oral hygiene instructions (Other)
结局指标
主要结局
change in Disease Activity score of 28 joints
时间窗: Two three monthly follow ups
≤ 3.2- inactive, \>3.2 but ≤ 5.1 - moderate and \> 5.1- very active
次要结局
- change in clinical attachment loss(Two three monthly follow ups)