- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03513263
Effect of Periodontal Care on Rhematoid Arthritis in Uganda
RCT: Evaluating the Effect of Oral Care for Periodontitis in Rhematoid Arthritis Patients in Uganda
연구 개요
상세 설명
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.
Objective 2 RCT study Participants will be randomized into an immediate intervention arm and a delayed intervention arm.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kampala, 우간다
- 모병
- Rheumatology clinic, medical outpatient department, Mulago national referral hospital and the Uganda
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연락하다:
- Mark KadduMukasa, PhD
- 전화번호: +256 772 633475
- 이메일: mkaddumukasa@chs.mak.ac.ug
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 18 years or older (of either gender).
- RA diagnosed at least 2 year before V0.
- DAS28 score between 3.2 and 5.1 during the month preceding V0.
- No change in medication, dose, or formulation in RA treatment during the 3 months preceding V0.
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: 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
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An electronic scaler will be used to clean the gums
It will include 15-minute oral session with visual and verbal information on how to use a toothbrush, dental floss, and mouthwash correctly; how to clean bridges and dentures; and how and why to use a plaque disclosing test to perform tooth cleaning
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가짜 비교기: 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
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It will include 15-minute oral session with visual and verbal information on how to use a toothbrush, dental floss, and mouthwash correctly; how to clean bridges and dentures; and how and why to use a plaque disclosing test to perform tooth cleaning
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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change in Disease Activity score of 28 joints
기간: Two three monthly follow ups
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≤ 3.2- inactive, >3.2 but ≤ 5.1 - moderate and > 5.1- very active
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Two three monthly follow ups
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
change in clinical attachment loss
기간: Two three monthly follow ups
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less than 2mm - improvement, more than 3 mm - getting worse
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Two three monthly follow ups
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공동 작업자 및 조사자
수사관
- 연구 책임자: Ian Munabi, PhD, MakCHS
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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