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NCT Number: NCT07661784

Salivary Biomarkers in Periodontal Disease Progression

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.

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Key information

Conditions

Periodontal Disease Bone Diseases Bone Diseases, Developmental Camurati-Engelmann Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Gingival Diseases Gingivitis Gingivitis and Periodontal Diseases Infections Mouth Diseases Musculoskeletal Diseases Osteochondrodysplasias Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Suleyman Demirel University

Isparta, 32000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Süleyman Demirel Üniversitesi Süleyman Demirel Üniversitesi

CONTACT

[email protected]

+90 (246) 211 8859

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saliva sampling

Other

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

Primary outcomes

  1. Salivary concentrations of IL-17, IL-23, IL-6, TGF-β, RANKL and OPG

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erensu Uzar Gürtan, DDS, PhD

CONTACT

[email protected]

+90 530 868 1519

Sponsors and collaborators

Lead sponsor

Suleyman Demirel University

Other

Registry information

Official study title

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

Acronym: PERIO-BIO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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