Salivary Biomarkers in Periodontal Disease Progression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Saliva Sampling.
- Who it may be relevant to
- Registry conditions: Periodontal Disease, Gingivitis and Periodontal Diseases, Periodontitis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Salivary Biomarkers Associated With Bone Remodeling in the Transition From Periodontal Health to Disease
Overview
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.
Detailed description
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.
Interventions
- Other Saliva Sampling
Collection of unstimulated saliva samples from participants for the analysis of inflammatory and bone remodeling-related biomarkers using ELISA methods.
Primary outcome measures
- Salivary concentrations of IL-17, IL-23, IL-6, TGF-β, RANKL and OPG [Time frame: At baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Turkey (Türkiye) · 1 center
- Suleyman Demirel University — Isparta
Publications
- 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. PMID 21323706
- 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. PMID 18199146
- 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. PMID 21406610
- 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. PMID 40197750
Identifiers
NCT: NCT07661784 · TMA-2025-9701