Salivary Biomarkers in Periodontal Disease Progression (PERIO-BIO)
Evaluation of Salivary Biomarkers Associated With Bone Remodeling in the Transition From Periodontal Health to Disease
This study aims to evaluate salivary biomarkers associated with bone remodeling during the transition from periodontal health to disease. Periodontal diseases are characterized by chronic inflammation that can lead to connective tissue destruction and alveolar bone loss. Although diagnosis is primarily based on clinical and radiographic findings, these methods may not fully reflect disease activity or progression.
In this observational study, individuals with periodontal health, gingivitis, and periodontitis will be included. Salivary levels of IL-17, IL-23, IL-6, TGF-β, RANKL, and OPG will be measured using ELISA. The relationship between these biomarkers and periodontal disease stage and grade will be analyzed.
The results are expected to improve understanding of the biological mechanisms underlying periodontal disease progression and to assess the potential role of salivary biomarkers in early diagnosis and personalized treatment approaches.
연구 개요
상세 설명
Periodontal diseases are chronic inflammatory conditions characterized by progressive destruction of the supporting tissues of the teeth, including connective tissue and alveolar bone. The transition from periodontal health to disease involves complex interactions between the host immune response and microbial factors, leading to alterations in bone remodeling processes.
Recent evidence suggests that salivary biomarkers may provide valuable insights into disease activity and progression. In particular, cytokines such as interleukin (IL)-17, IL-23, and IL-6, as well as bone remodeling-related markers including transforming growth factor-beta (TGF-β), receptor activator of nuclear factor-kappa B ligand (RANKL), and osteoprotegerin (OPG), are thought to play critical roles in the pathogenesis of periodontal disease.
This observational study is designed to investigate the levels of these salivary biomarkers in individuals with periodontal health, gingivitis, and periodontitis. Participants will be classified according to established periodontal disease staging and grading criteria. Unstimulated saliva samples will be collected and analyzed using enzyme-linked immunosorbent assay (ELISA) methods.
The primary objective is to evaluate differences in biomarker levels among study groups and to assess their association with periodontal disease severity. Secondary analyses will explore correlations between biomarker profiles and clinical periodontal parameters.
The findings of this study are expected to contribute to a better understanding of the biological mechanisms underlying periodontal disease progression and to support the potential use of salivary biomarkers as non-invasive tools for early diagnosis and personalized treatment planning.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Erensu Uzar Gürtan, DDS, PhD
- 전화번호: +90 530 868 1519
- 이메일: erensu.uzar@icloud.com
연구 장소
-
-
-
Isparta, 터키 (Türkiye), 32000
- 모병
- Suleyman Demirel University
-
연락하다:
- Süleyman Demirel Üniversitesi Süleyman Demirel Üniversitesi
- 전화번호: +90 (246) 211 8859
- 이메일: tipetik@sdu.edu.tr
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Adults aged 18-65 years Systemically healthy individuals Individuals classified as periodontally healthy, gingivitis, or periodontitis according to clinical periodontal examination Ability and willingness to provide informed consent
Exclusion Criteria:
Presence of systemic diseases affecting periodontal status (e.g., diabetes mellitus, immunological disorders) Use of antibiotics or anti-inflammatory drugs within the last 3 months History of periodontal treatment within the last 6 months Pregnancy or lactation Smoking (optional ) Any condition that may affect salivary biomarker levels
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Periodontally Healthy
Individuals with clinically healthy periodontal tissues, no signs of gingival inflammation, and no clinical attachment loss.
Unstimulated saliva samples will be collected for biomarker analysis.
|
Collection of unstimulated saliva samples from participants for the analysis of inflammatory and bone remodeling-related biomarkers using ELISA methods.
|
|
Gingivitis
Individuals diagnosed with gingivitis characterized by gingival inflammation without clinical attachment loss.
Unstimulated saliva samples will be collected for biomarker analysis.
|
Collection of unstimulated saliva samples from participants for the analysis of inflammatory and bone remodeling-related biomarkers using ELISA methods.
|
|
Periodontitis
Individuals diagnosed with periodontitis presenting clinical attachment loss and radiographic evidence of alveolar bone loss.
Unstimulated saliva samples will be collected for biomarker analysis.
|
Collection of unstimulated saliva samples from participants for the analysis of inflammatory and bone remodeling-related biomarkers using ELISA methods.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Salivary concentrations of IL-17, IL-23, IL-6, TGF-β, RANKL and OPG
기간: At baseline
|
Salivary concentrations of IL-17, IL-23, IL-6, TGF-β, RANKL and OPG measured using enzyme-linked immunosorbent assay (ELISA).
Biomarker concentrations will be reported in pg/mL and compared among periodontal health, gingivitis and periodontitis groups.
|
At baseline
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Buduneli N, Kinane DF. Host-derived diagnostic markers related to soft tissue destruction and bone degradation in periodontitis. J Clin Periodontol. 2011 Mar;38 Suppl 11:85-105. doi: 10.1111/j.1600-051X.2010.01670.x.
- Graves DT, Fine D, Teng YT, Van Dyke TE, Hajishengallis G. The use of rodent models to investigate host-bacteria interactions related to periodontal diseases. J Clin Periodontol. 2008 Feb;35(2):89-105. doi: 10.1111/j.1600-051X.2007.01172.x.
- Kinney JS, Morelli T, Braun T, Ramseier CA, Herr AE, Sugai JV, Shelburne CE, Rayburn LA, Singh AK, Giannobile WV. Saliva/pathogen biomarker signatures and periodontal disease progression. J Dent Res. 2011 Jun;90(6):752-8. doi: 10.1177/0022034511399908. Epub 2011 Mar 15.
- Dommisch H, Hoedke D, Lu EM, Schafer A, Richter G, Kang J, Nibali L. Genetic Biomarkers for Periodontal Diseases: A Systematic Review. J Clin Periodontol. 2025 Aug;52 Suppl 29(Suppl 29):182-210. doi: 10.1111/jcpe.14149. Epub 2025 Apr 8.
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 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- TMA-2025-9701
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .