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NCT Number: NCT07475013

Effects of Non-Surgical Periodontal Treatment on Inflammatory and Bone Markers in Periodontitis Patients

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Periodontitis (Stage 3) Bone Diseases Bone Diseases, Developmental Camurati-Engelmann Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Mouth Diseases Musculoskeletal Diseases Osteochondrodysplasias Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi

Ankara, 06010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Scaling and Root Planing (SRP)

Procedure

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Acronym: GPNMB-PERIO St

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Apr 27, 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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