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

April 22, 2026 updated by: Özlem SARAÇ ATAGÜN, Saglik Bilimleri Universitesi

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Gingival Crevicular Fluid (GCF) Glycoprotein Non-Metastatic B (GPNMB) Concentration
Time Frame: Baseline, 6 weeks, and 3 months post-treatment.
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
Time Frame: Baseline, 6 weeks post-treatment, and 3 months post-treatment.
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
Time Frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
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
Time Frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
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
Time Frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
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
Time Frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
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
Time Frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
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
Time Frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Probing Pocket Depth (PPD)
Time Frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
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)
Time Frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
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)
Time Frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
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)
Time Frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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