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

NCT07475013 | Active Not Recruiting

• 1 other identifier: OSATAGUN5
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis (Stage 3)

Keywords

TGF-beta1; GPNMB; RANKL; OPG; Periodontitis; non-surgical periodontal treatment

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• Change in Probing Pocket Depth (PPD)

  Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.

• Change in Clinical Attachment Loss (CAL)

  Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.

• Change in Plaque Index (PI)

  Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.

• Change in Gingival Index (GI)

  Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.

Study Arms (2)

Periodontitis Group

EXPERIMENTAL

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)

Healthy Control Group

NO INTERVENTION

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.

Interventions

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.

Periodontitis Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis; Camurati-Engelmann Syndrome

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 16, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)