Biomarkers for Differentiating Reversible and Irreversible Pulpitis (PULPBIOM)
Role of Inflammatory, Oxidative Stress, Neurogenic, and Immunological Biomarkers in Pulp Blood for the Differential Diagnosis of Reversible and Irreversible Pulpitis
This observational study aims to evaluate the role of inflammatory, oxidative stress, neurogenic, and immunological biomarkers obtained from pulpal blood in the differential diagnosis of normal pulp, reversible pulpitis, and irreversible pulpitis.
A total of 75 teeth from systemically healthy individuals aged 12-35 years will be included and classified into three groups: normal pulp, reversible pulpitis, and irreversible pulpitis, based on clinical examination, radiographic findings, and pulp sensibility tests. No additional treatment procedures will be performed for research purposes. All dental procedures will be carried out according to routine clinical protocols.
During routine treatment, after pulp exposure, approximately 50 μL of pulpal blood that would otherwise be discarded as medical waste will be collected using a micropipette. Samples will be stored and analyzed using ELISA to determine the levels of inflammatory, neurogenic, immunological, and oxidative stress biomarkers. The results will be compared among the three groups to identify biomarkers that may improve the accuracy of pulpitis diagnosis and support clinical decision-making.
연구 개요
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Kütahya
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Kütahya, Kütahya, 터키 (Türkiye), 43100
- Kütahya Health Sciences University Faculty of Dentistry
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Individuals aged 12 to 35 years
- Systemically healthy individuals
- Patients presenting for routine restorative treatment or root canal treatment
- Teeth classified into one of the following pulpal status groups: healthy pulp, reversible pulpitis, or irreversible pulpitis
- Confirmation of pulp vitality by pulp sensibility tests
- Ability to obtain pulp exposure and collect an adequate pulpal blood sample during treatment
Exclusion Criteria:
- No response to pulp sensibility tests
- Teeth that are not restorable
- Presence of a sinus tract
- Radiographic evidence of periapical pathology
- Presence of internal or external root resorption
- Teeth with open apices
- Presence of systemic disease
- Pregnancy
- History of NSAID or antibiotic use within the last week
- Requirement for prophylactic antibiotic use
- Teeth in which pulp exposure cannot be achieved after complete caries removal
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Normal Pulp
Teeth diagnosed with healthy pulp and scheduled for elective root canal treatment due to prosthetic indications.
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Collection of pulpal blood samples during routine dental treatment followed by biomarker analysis using ELISA.
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Reversible Pulpitis
Teeth diagnosed with reversible pulpitis based on clinical examination, radiographic findings, and pulp sensibility tests.
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Collection of pulpal blood samples during routine dental treatment followed by biomarker analysis using ELISA.
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Irreversible Pulpitis
Teeth diagnosed with irreversible pulpitis based on clinical examination, radiographic findings, and pulp sensibility tests.
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Collection of pulpal blood samples during routine dental treatment followed by biomarker analysis using ELISA.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Levels of inflammatory, neurogenic, immunological, and oxidative stress biomarkers in pulpal blood samples
기간: At the time of treatment (baseline)
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Comparison of TNF-α, IL-6, IL-10, MMP-9, TGF-β1, Presepsin, Substance P, SEMA3A, SEMA4D, SEMA7A, TAS, TOS, MDA, GSH, and SOD levels among healthy pulp, reversible pulpitis, and irreversible pulpitis groups.
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At the time of treatment (baseline)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Diagnostic performance of pulpal blood biomarkers
기간: At the time of treatment (baseline)
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Evaluation of the ability of measured biomarkers to differentiate healthy pulp, reversible pulpitis, and irreversible pulpitis.
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At the time of treatment (baseline)
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
기타 연구 ID 번호
- KURNAZ-PULPBIOMARKERS
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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