Evaluation of PTHrP, RANKL, and OPG Levels in Periodontal Health and Diseases

NCT07793370 | Active Not Recruiting

• 1 other identifier: BAIBU-SBF-BMY-03
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to evaluate the levels of specific biological markers-Parathyroid Hormone-Related Protein (PTHrP), RANKL, and Osteoprotegerin (OPG)-in the gingival crevicular fluid of individuals with different gum health conditions. The study includes a total of 81 participants, divided equally into three groups: 27 with healthy gums, 27 with gingivitis, and 27 with periodontitis. During a routine dental visit, participants undergo a standard periodontal examination to measure clinical signs such as plaque levels, gum bleeding, and pocket depths. Additionally, small sterile paper strips are gently placed in the gum crevices for 30 seconds to collect fluid samples. These fluid samples are then analyzed in a laboratory to understand how these specific proteins relate to gum health and the severity of gum disease.

Conditions

Periodontitis; Gingivitis; Periodontal Disease

Keywords

Parathyroid Hormone-Related Protein; RANK Ligand; Osteoprotegerin; Gingival Crevicular Fluid; Biomarkers

Outcome Measures

Primary Outcomes (3)

• GCF Level of PTHrP

  The concentration of PTHrP in GCF samples will be quantitatively measured using commercial ELISA kits.

  Baseline (Single time point during the clinical examination)

• GCF Level of RANKL

  The concentration of RANKL in GCF samples will be quantitatively measured using commercial ELISA kits.

  Baseline (Single time point during the clinical examination)

• GCF Level of Osteoprotegerin

  The concentration of OPG in GCF samples will be quantitatively measured using commercial ELISA kits.

  Baseline (Single time point during the clinical examination)

Secondary Outcomes (4)

• Probing Depth (PD)

  Baseline (Single time point during the clinical examination)

• Clinical Attachment Level (CAL)

  Baseline (Single time point during the clinical examination)

• Gingival Index (GI)

  Baseline (Single time point during the clinical examination)

• Plaque Index (PI)

  Baseline (Single time point during the clinical examination)

Study Arms (3)

Periodontally Healthy

27 individuals with probing depth (PD) ≤ 3 mm, bleeding on probing (BOP) \< 10%, and no interproximal clinical attachment loss (CAL) or radiographic bone loss (RBL).

Other: Routine periodontal clinical examination and GCF collection

Gingivitis

27 individuals with PD ≤ 3 mm, BOP ≥ 30%, and no CAL or RBL.

Other: Routine periodontal clinical examination and GCF collection

Periodontitis

27 individuals diagnosed with Stage III periodontitis, characterized by interproximal CAL ≥ 5 mm, PD ≥ 6 mm, and RBL extending to the middle third of the root or more apically.

Other: Routine periodontal clinical examination and GCF collection

Interventions

Routine periodontal clinical examination and GCF collection OTHER

A comprehensive clinical periodontal examination is performed by a single calibrated examiner using a periodontal probe. The examination includes the measurement of Plaque Index (PI), Gingival Index (GI), PD, and CAL. For GCF collection, the specified interproximal sites are isolated with cotton rolls, gently air-dried, and cleared of supragingival plaque. GCF samples are then collected using sterile filter paper strips inserted into the sulcus until mild resistance is felt and left in place for 30 seconds.

Gingivitis; Periodontally Healthy; Periodontitis

Eligibility Criteria

• Age: 18 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 adult individuals seeking dental care at the Department of Periodontology, Faculty of Dentistry, Bolu Abant Izzet Baysal University. The population includes a total of 81 participants representing three distinct periodontal conditions: individuals with a healthy periodontium, individuals diagnosed with gingivitis, and individuals diagnosed with Stage III periodontitis.

You may qualify if:

• Individuals aged 18 years and older.
• Presence of at least 20 natural teeth, excluding third molars.
• For the Periodontally Healthy GrouP: PD ≤ 3 mm, BOP \< 10%, and no interproximal CAL or RBL.
• For the Gingivitis Group: PD ≤ 3 mm, BOP ≥ 30%, and no interproximal CAL or RBL.
• For the Periodontitis Group: Diagnosed with Stage III periodontitis (interproximal CAL ≥ 5 mm, PD ≥ 6 mm, and RBL extending to the middle third of the root or more apically).

You may not qualify if:

• Presence of systemic diseases that may affect periodontal tissues (e.g., cardiovascular diseases, atherosclerosis, immune system diseases, rheumatoid arthritis, obesity, cancer, and diabetes).
• Use of antibiotics within the last 3 months.
• Use of any medication that may affect periodontal tissues.
• Presence of infectious diseases such as HIV, HBV, or tuberculosis.
• Pregnancy or lactation.
• History of periodontal treatment within the last 6 months.
• Smoking

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant İzzet Baysal University, Faculty of Dentistry, Department of Periodontology

Bolu, Gölköy, 14030, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid samples collected from interproximal sites using sterile filter paper strips for biochemical analysis

MeSH Terms

Conditions

Periodontitis; Gingivitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Study Design

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

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 28, 2026
• Study Start: June 1, 2026
• Primary Completion: July 24, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)