Effects of Non-Surgical Periodontal Treatment on Inflammatory and Bone Markers in Periodontitis Patients (GPNMB-PERIO St)

Evaluation of the Effects of Non-Surgical Periodontal Therapy on Serum and Gingival Crevicular Fluid Levels of Glycoprotein Non-Metastatic B (GPNMB), TGF-β1, RANKL, and Osteoprotegerin in Patients With Periodontitis

The goal of this study is to learn how a standard treatment called Scaling and Root Planing (SRP) affects specific biochemical markers in people with advanced gum disease (periodontitis). Periodontitis is a chronic condition that can lead to tooth loss.

The main focus is to investigate a marker called Glycoprotein Non-Metastatic B (GPNMB). This is the first study to examine GPNMB levels in both the serum and the gingival crevicular fluid of people with this condition. The study aims to answer these main questions:

How do GPNMB levels change after the Scaling and Root Planing treatment?

How does GPNMB relate to other markers that control bone health and healing, such as TGF-β1, RANKL, and Osteoprotegerin?

Researchers will compare 28 participants with advanced gum disease (Stage III Grade B/C) to 28 participants with healthy gums to see how these markers differ.

Participants in the gum disease group will:

Provide samples for laboratory analysis at the start of the study.

Receive the standard mechanical treatment of their teeth and roots (Scaling and Root Planing).

Return for follow-up visits 6 weeks and 3 months after treatment to provide new samples and have their gum health checked.

Study Overview

• Status: Active, not recruiting
• Conditions: Periodontitis (Stage 3)
• Intervention / Treatment: Procedure: Scaling and Root Planing (SRP)

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06010
    • Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Systemically healthy individuals
• Individuals diagnosed with Stage III Grade B or Grade C periodontitis (for the periodontitis group)
• Periodontally healthy individuals (for the healthy control group)
• Participants aged 18 years and older

Exclusion Criteria:

• Individuals who have received periodontal treatment within the last 6 months
• Individuals who have used antibacterial drugs within the last 6 months
• Individuals with any systemic disease
• Individuals who use medications on a regular basis
• Current smokers
• Pregnant individuals
• Participants under the age of 18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Periodontitis Group; Participants with Stage III Grade B/C periodontitis. At baseline, clinical periodontal measurements are recorded, and serum and gingival crevicular fluid samples are collected. All participants receive non-surgical periodontal therapy consisting of Scaling and Root Planing (SRP). Follow-up visits are conducted at 6 weeks and 3 months post-treatment for repeated clinical assessments and sample collection to evaluate changes in biochemical markers (GPNMB, TGF-β1, RANKL, and OPG).	Procedure: Scaling and Root Planing (SRP); A standard non-surgical mechanical treatment that involves the removal of plaque and calculus from the teeth and root surfaces using ultrasonic devices and hand instruments.
No Intervention: Healthy Control Group; Periodontally healthy individuals. Participants undergo a single clinical periodontal examination and provide serum and gingival crevicular fluid samples at the baseline visit. This group serves as a reference for baseline biochemical marker levels. No therapeutic intervention is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gingival Crevicular Fluid (GCF) Glycoprotein Non-Metastatic B (GPNMB) Concentration	Concentration of GPNMB in gingival crevicular fluid samples measured by Enzyme-Linked Immunosorbent Assay (ELISA). Results will be expressed in picograms per microliter (pg/µL) to evaluate the local biochemical response following scaling and root planing (SRP).	Baseline, 6 weeks, and 3 months post-treatment.
Change in Serum Glycoprotein Non-Metastatic B (GPNMB) Concentration	Concentration of GPNMB in serum samples measured by Enzyme-Linked Immunosorbent Assay (ELISA) to evaluate the systemic biochemical response. The results will be quantified and reported in picograms per milliliter (pg/mL) to evaluate the change in mean concentration values across the specified measurement intervals.	Baseline, 6 weeks post-treatment, and 3 months post-treatment.
Change in Gingival Crevicular Fluid (GCF) Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) Concentration	Concentration of RANKL in gingival crevicular fluid samples measured via ELISA to assess local bone resorption activity. The data will be quantified in picograms per microliter (pg/µL) at baseline and post-treatment intervals.	Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Serum Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) Concentration	Concentration of RANKL in serum samples measured by ELISA to evaluate the systemic bone resorption activity. The results will be quantified and reported in picograms per milliliter (pg/mL) to evaluate the change in mean concentration values across the specified measurement intervals following periodontal therapy.	Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Gingival Crevicular Fluid (GCF) Osteoprotegerin (OPG) Concentration	Concentration of OPG in gingival crevicular fluid samples measured by ELISA to assess the local bone-protective response. The results will be quantified and reported in picograms per microliter (pg/µL) to evaluate the change in mean concentration values across the specified measurement intervals following scaling and root planing (SRP).	Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Serum Osteoprotegerin (OPG) Concentration	Concentration of OPG in serum samples measured by ELISA to evaluate the systemic bone-protective response. Measurement values will be reported in picograms per milliliter (pg/mL) to compare the changes in mean concentration values across the specified measurement intervals following periodontal therapy.	Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Gingival Crevicular Fluid (GCF) Transforming Growth Factor beta 1 (TGF-β1) Concentration	Concentration of TGF-β1 in gingival crevicular fluid samples measured by Enzyme-Linked Immunosorbent Assay (ELISA). This analysis evaluates the local anti-inflammatory response and tissue healing following scaling and root planing (SRP). The results will be quantified and reported in picograms per microliter (pg/µL) to evaluate the change in mean concentration values across the specified measurement intervals.	Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Serum Transforming Growth Factor beta 1 (TGF-β1) Concentration	Concentration of TGF-β1 in serum samples measured by ELISA to evaluate the systemic anti-inflammatory response. Measurement values will be reported in picograms per milliliter (pg/mL) to compare the changes before and after scaling and root planing (SRP).	Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Probing Pocket Depth (PPD)	Probing Pocket Depth (PPD) will be measured at six sites per tooth using a Williams periodontal probe to evaluate the depth of the periodontal pockets.	Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Clinical Attachment Loss (CAL)	Clinical Attachment Loss (CAL) will be measured at six sites per tooth using a Williams periodontal probe to assess the level of periodontal tissue attachment.	Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Plaque Index (PI)	Plaque Index (PI) will be used to assess the amount of plaque on the tooth surfaces to evaluate oral hygiene status.	Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Gingival Index (GI)	Gingival Index (GI) will be used to assess the severity of gingival inflammation based on color, consistency, and bleeding tendency.	Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Periodontitis; GPNMB; OPG; RANKL; TGF-beta1; non-surgical periodontal treatment
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Genetic Diseases, Inborn; Osteochondrodysplasias; Bone Diseases, Developmental; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Periodontitis; Camurati-Engelmann Syndrome; Digestive System and Oral Physiological Phenomena; Dentistry; Dental Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Subgingival Curettage; Preventive Dentistry; Root Planing; Tooth Exfoliation
• Other Study ID Numbers: OSATAGUN5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No