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Salivary Biomarkers in Periodontal Disease Progression

Evaluation of Salivary Biomarkers Associated With Bone Remodeling in the Transition From Periodontal Health to Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07661784
Acronym
PERIO-BIO
Enrollment
240
Registered
2026-06-22
Start date
2025-07-10
Completion date
2026-08-30
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis and Periodontal Diseases, Periodontal Disease, Periodontitis

Keywords

Periodontal Disease, Gingivitis, Periodontitis, Salivary Biomarkers, Bone Remodeling, Interleukin-17 (IL-17), Interleukin-23 (IL-23), Interleukin-6 (IL-6), Transforming Growth Factor Beta (TGF-β), RANKL, Osteoprotegerin (OPG), ELISA, Non-invasive Diagnosis

Brief summary

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

Collection of unstimulated saliva samples from participants for the analysis of inflammatory and bone remodeling-related biomarkers using ELISA methods.

Sponsors

Suleyman Demirel University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Salivary concentrations of IL-17, IL-23, IL-6, TGF-β, RANKL and OPGAt baselineSalivary 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTErensu Uzar Gürtan, DDS, PhD
erensu.uzar@icloud.com+90 530 868 1519

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026