- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07666126
Evaluation of the Effect of Hyperuricemia on Alveolar Bone Loss
Evaluation of the Effect of Hyperuricemia on Alveolar Bone Loss and Oxidative Stress
Periodontitis is a multifactorial disease characterized by chronic inflammation of the gum tissue and alveolar bone destruction, and is known to be associated with various systemic diseases. Hyperuricemia, on the other hand, is a metabolic condition characterized by increased serum uric acid levels and can affect inflammation, oxidative stress, and bone metabolism. In recent years, the relationship between hyperuricemia and periodontal diseases has been increasingly investigated, but the biological mechanisms of this relationship have not yet been fully elucidated. Therefore, this study aimed to determine whether there is a relationship between hyperuricemia and periodontitis and to reveal the possible pathophysiological mechanisms of this relationship, which are shaped by inflammation, oxidative stress, and bone metabolism.
A total of 80 individuals aged 18-65 years will be included in this clinical observational study. The periodontal status of the participants will be assessed using clinical periodontal parameters such as probing pocket depth, clinical attachment loss, plaque index, gingival index, and bleeding on probing. Participants will be divided into four groups according to their periodontal status and the presence of hyperuricemia: individuals with periodontitis and hyperuricemia, individuals with periodontally healthy and hyperuricemia, individuals with periodontitis but without hyperuricemia, and individuals with periodontally healthy and without hyperuricemia. Gingival crevicular fluid and serum samples will be taken from the participants. In these samples, receptor-mediated nuclear factor kappa B ligand, osteoprotegerin, total antioxidant status, total oxidant status, oxidative stress index, interleukin-1 beta, interleukin-10, interleukin-18, and nucleotide-binding oligomerization domain-like receptor protein 3 levels will be analyzed. This study is considered unique because it examines the relationship between hyperuricemia and periodontitis by evaluating inflammation, oxidative stress, and bone metabolism parameters together.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Hatice Yemenoglu
- 전화번호: +905052977517
- 이메일: htcymnglu@hotmail.com
연구 장소
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Rize, 터키 (Türkiye), 53020
- 모병
- Recep Tayyip Erdogan University
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연락하다:
- Hatice Yemenoglu
- 전화번호: +904642220000
- 이메일: htcymnglu@hotmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Being between 18 and 65 years of age
- Being systemically healthy or diagnosed with hyperuricemia
- Having at least 20 natural teeth
- Being periodontally healthy or diagnosed with periodontitis
Exclusion Criteria:
- Diabetes, cardiovascular disease, osteoporosis, chronic kidney disease, metabolic syndrome, and obesity are systemic diseases that may affect purine metabolism.
- Smoking
- Pregnancy or lactation
- Having received periodontal treatment within the last 3-6 months
- Use of antibiotics, anti-inflammatory drugs, or uric acid-lowering drugs
- Presence of systemic diseases that may affect purine metabolism
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Group 1: Individuals with periodontitis and hyperuricemia
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Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
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Group 2: Periodontally healthy individuals with hyperuricemia
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Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
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Group 3: Individuals with periodontitis but without hyperuricemia
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Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
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Group 4: Periodontally healthy individuals without hyperuricemia
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Serum and GCF samples will be collected from participants in the first session
Periodontal clinical parameters will be measured from participants initially
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Periodontal pocket depth
기간: at baseline
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The distance between the gingival margin and the base of the pocket will be measured in millimeters.
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at baseline
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clinical attachment loss
기간: at baseline
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The distance between the enamel-cementum junction and the base of the pocket will be measured in millimeters.
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at baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Level of interleukin-1 beta
기간: at baseline
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Interleukin-1 beta levels will be determined from gingival crevicular fluid and serum samples using the ELISA method.
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at baseline
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Level of interleukin-10
기간: at baseline
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Interleukin-10 levels will be determined from gingival crevicular fluid and serum samples using the ELISA method.
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at baseline
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Level of interleukin-18
기간: at baseline
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Interleukin-18 levels will be determined from gingival crevicular fluid and serum samples using the ELISA method.
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at baseline
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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. .