Salivary Biomarkers in Periodontal Disease Progression

NCT07661784 | Recruiting

• 1 other identifier: TMA-2025-9701
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Disease; Gingivitis and Periodontal Diseases; 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

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (3)

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.

Other: Saliva Sampling

Gingivitis

Individuals diagnosed with gingivitis characterized by gingival inflammation without clinical attachment loss. Unstimulated saliva samples will be collected for biomarker analysis.

Other: Saliva Sampling

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.

Other: Saliva Sampling

Interventions

Saliva Sampling OTHER

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

Gingivitis; Periodontally Healthy; Periodontitis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of systemically healthy adult individuals aged 18-65 years who attend the Department of Periodontology at Suleyman Demirel University for routine dental examination and periodontal evaluation. Participants will be classified into periodontally healthy, gingivitis, and periodontitis groups based on clinical periodontal findings.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University

Isparta, 32000, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Unstimulated whole saliva samples will be collected from participants using standard collection protocols. The samples will be processed and stored under appropriate laboratory conditions for the analysis of inflammatory and bone remodeling-related biomarkers, including IL-17, IL-23, IL-6, TGF-β, RANKL, and OPG. No DNA or genetic analyses will be performed.

MeSH Terms

Conditions

Periodontal Diseases; Gingivitis; Periodontitis; Camurati-Engelmann Syndrome

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Erensu Uzar Gürtan, DDS, PhD

CONTACT

+90 530 868 1519; erensu.uzar@icloud.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Periodontology

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: June 22, 2026
• Study Start: July 10, 2025
• Primary Completion: July 10, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)