- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07607639
Evaluation of Gingival Crevicular Fluid Cytokine Profiles in Children and Young Adults With Gingivitis
Comparison of Gingival Crevicular Fluid Biomarkers Between Childhood Gingivitis and Adolescent Gingivitis
This prospective observational case-control study aims to compare gingival crevicular fluid (GCF) biomarker profiles between children and young adults diagnosed with gingivitis. A total of approximately 80 systemically healthy participants will be recruited and divided into two groups: children aged 8-12 years and young adults aged 15-24 years. Individuals aged 13-14 years will be excluded as they represent a transitional pubertal period characterized by significant hormonal fluctuations that may influence inflammatory responses and confound biomarker levels.
Clinical periodontal parameters including gingival index, plaque index, bleeding on probing, and probing depth will be recorded. In addition, GCF samples will be collected from a standardized tooth and analyzed for levels of IL-1β, TNF-α, IL-10, and MMP-8 using enzyme-linked immunosorbent assay (ELISA).
The primary objective of the study is to evaluate and compare inflammatory and anti-inflammatory cytokine profiles between the two age groups. The findings may contribute to understanding age-related differences in gingival inflammatory responses and the potential role of hormonal transition in periodontal disease expression during childhood and early adulthood.
연구 개요
상세 설명
Gingivitis is the most common reversible periodontal disease in children and young adults and is characterized by gingival inflammation without periodontal attachment loss. Gingival crevicular fluid (GCF) contains inflammatory mediators and biomarkers that reflect periodontal tissue response and disease activity.
This prospective observational case-control study aims to compare GCF biomarker profiles between children and young adults diagnosed with gingivitis. Approximately 80 systemically healthy participants will be recruited and divided into two groups: children aged 8-12 years and young adults aged 15-24 years. Individuals aged 13-14 years will be excluded due to pubertal hormonal variability that may affect inflammatory biomarker levels.
Clinical periodontal parameters including Gingival Index, Plaque Index, Bleeding on Probing, and Probing Depth will be recorded. GCF samples will be collected from tooth #31 using standardized paper strips and analyzed for IL-1β, TNF-α, IL-10, and MMP-8 levels using ELISA.
The findings may contribute to understanding age-related differences in gingival inflammatory responses and biomarker expression in gingivitis.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Aycan Dal Dönertaş
- 전화번호: +903382252595
- 이메일: aycandal@outlook.com
연구 연락처 백업
- 이름: Selcen Özcan Bulut
- 이메일: selcen_ozcan@hotmail.com
연구 장소
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Niğde, 터키 (Türkiye), 51240
- 모병
- Niğde Ömer Halisdemir University Faculty of Dentistry
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연락하다:
- Merdan Doğan
- 전화번호: 905422076565
- 이메일: merdan@ohu.edu.tr
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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 8-12 years (child group) or 15-24 years (young adult group)
- Clinical diagnosis of gingivitis
- Presence of fully erupted tooth #31 with closed apex
- Systemically healthy individuals
- No history of periodontal treatment in the last 3 months
- No antibiotic or anti-inflammatory drug use in the last 3 months
- Good cooperation and willingness to participate
- Written informed consent from participants or legal guardians (for minors)
Exclusion Criteria:
- Age 13-14 years (transitional pubertal period)
- Presence of periodontitis or other periodontal diseases
- Systemic, genetic, or immunological diseases
- Acute oral infections or conditions requiring emergency treatment
- Orthodontic appliances in the sampling region
- Smokers
- Pregnant or lactating individuals
- Individuals with cognitive, psychological, or physical disabilities affecting cooperation
- Inadequate eruption or incomplete root development of tooth #31
- Refusal to participate or withdrawal of consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Childhood gingivitis group
Systemically healthy children aged 8-12 years diagnosed with gingivitis who will undergo clinical periodontal examination and gingival crevicular fluid biomarker analysis.
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Gingival crevicular fluid (GCF) samples will be collected from a standardized tooth (#31) using sterile absorbent paper strips (Periopaper®). Samples will be obtained after isolation and drying of the sampling site to avoid saliva contamination. Each strip will be placed gently in the gingival sulcus until mild resistance is felt and maintained for 30 seconds. Collected samples will be immediately stored at -80°C until laboratory analysis. Levels of inflammatory and anti-inflammatory biomarkers including IL-1β, TNF-α, IL-10, and MMP-8 will be quantified using enzyme-linked immunosorbent assay (ELISA) kits according to manufacturer instructions. This procedure is non-invasive and performed for diagnostic and comparative biomarker analysis purposes only. |
|
Young adult gingivitis group
Systemically healthy young adults aged 15-24 years diagnosed with gingivitis who will undergo clinical periodontal examination and gingival crevicular fluid biomarker analysis.
|
Gingival crevicular fluid (GCF) samples will be collected from a standardized tooth (#31) using sterile absorbent paper strips (Periopaper®). Samples will be obtained after isolation and drying of the sampling site to avoid saliva contamination. Each strip will be placed gently in the gingival sulcus until mild resistance is felt and maintained for 30 seconds. Collected samples will be immediately stored at -80°C until laboratory analysis. Levels of inflammatory and anti-inflammatory biomarkers including IL-1β, TNF-α, IL-10, and MMP-8 will be quantified using enzyme-linked immunosorbent assay (ELISA) kits according to manufacturer instructions. This procedure is non-invasive and performed for diagnostic and comparative biomarker analysis purposes only. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Gingival crevicular fluid TNF-α levels
기간: Baseline
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Baseline
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Gingival crevicular fluid IL-1β levels
기간: Baseline
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Baseline
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Gingival crevicular fluid IL-10 levels
기간: Baseline
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Baseline
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Gingival crevicular fluid MMP-8 levels
기간: Baseline
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Baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gingival Index
기간: Baseline
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Gingival inflammation will be assessed using the Löe and Silness Gingival Index. Each surface will be scored between 0 and 3: 0 = normal gingiva
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Baseline
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Plaque Index
기간: Baseline
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Dental plaque accumulation will be evaluated using the Silness and Löe Plaque Index. Each surface will be scored between 0 and 3: 0 = no plaque
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Baseline
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Bleeding on Probing Scores Assessed by Periodontal Probing
기간: Baseline
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Bleeding on probing will be evaluated using a periodontal probe after gentle probing of the gingival sulcus. Bleeding presence will be recorded dichotomously: 0 = absence of bleeding 1 = presence of bleeding Higher scores indicate greater gingival inflammation. |
Baseline
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Periodontal Probing Depth Measurements Assessed With Williams Periodontal Probe
기간: Baseline
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Periodontal probing depth will be measured in millimeters using a Williams periodontal probe at six sites per tooth.
Higher values indicate deeper periodontal pockets and worse periodontal condition.
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Baseline
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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. .