Evaluation of Serum TRACP-5b, BALP, and 25-Hydroxyvitamin D3 Levels in Stage III Periodontitis Patients (TRACP-BALP-D3)

February 23, 2026 updated by: Tugba Aydin, Ataturk University

Evaluation of the Effects of Non-Surgical Periodontal Therapy on Serum TRACP-5b, BALP, and 25-Hydroxyvitamin D3 Levels in Patients With Stage III Periodontitis

Periodontitis is a chronic inflammatory disease characterized by the progressive destruction of the supporting tissues of the teeth. Non-surgical periodontal therapy is the first-line treatment approach and aims to control inflammation and prevent further tissue breakdown.

The aim of this interventional clinical study is to evaluate the effects of non-surgical periodontal therapy on serum levels of tartrate-resistant acid phosphatase 5b (TRACP-5b), bone alkaline phosphatase (BALP), and 25-hydroxyvitamin D3 in patients diagnosed with Stage III periodontitis.

Patients with Stage III periodontitis will receive non-surgical periodontal therapy consisting of scaling and root planing. Clinical periodontal parameters and blood samples will be collected at baseline and after treatment. Changes in serum biomarker levels before and after therapy will be analyzed to assess the relationship between periodontal treatment and bone metabolism-related biomarkers.

The findings of this study are expected to contribute to a better understanding of the systemic biochemical response to periodontal therapy in patients with advanced periodontitis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This interventional clinical study is designed to investigate the effects of non-surgical periodontal therapy on systemic bone metabolism-related biomarkers in patients diagnosed with Stage III periodontitis.

Eligible participants are systemically healthy individuals diagnosed with Stage III periodontitis according to the current periodontal classification. After enrollment, all participants will undergo non-surgical periodontal therapy consisting of scaling and root planing performed using standard clinical protocols.

Clinical periodontal parameters will be recorded at baseline and following the completion of periodontal therapy. Venous blood samples will be collected at baseline and at the post-treatment evaluation time point. Serum levels of tartrate-resistant acid phosphatase 5b (TRACP-5b), bone alkaline phosphatase (BALP), and 25-hydroxyvitamin D3 will be measured using standardized laboratory methods.

The primary objective of the study is to evaluate changes in serum levels of TRACP-5b, BALP, and 25-hydroxyvitamin D3 following non-surgical periodontal therapy. Secondary objectives include the assessment of clinical periodontal parameter changes and the exploration of associations between clinical findings and biochemical markers.

Data obtained before and after treatment will be analyzed to assess the systemic biochemical response to periodontal therapy. The results of this study may provide additional insight into the relationship between periodontal treatment and markers associated with bone metabolism.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • 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 Locations

  • Turkey (Türkiye)
    • Erzurum
      • Erzurum, Erzurum, Turkey (Türkiye)
        • Atatürk University Faculty of Dentistry

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 to 65 years
  • Diagnosed with Stage III periodontitis according to the current periodontal classification
  • Systemically healthy individuals
  • Presence of at least 20 natural teeth
  • Willingness to participate in the study and provide written informed consent

Exclusion Criteria:

  • Presence of systemic diseases that may affect periodontal status or bone metabolism
  • Use of antibiotics, anti-inflammatory drugs, or medications affecting bone metabolism within the last 3 months
  • Pregnancy or lactation
  • Current smokers or history of smoking
  • Previous periodontal treatment within the last 6 months

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-Surgical Periodontal Therapy
Participants with Stage III periodontitis receive non-surgical periodontal therapy consisting of scaling and root planing performed according to standard clinical protocols.
Procedure: Non-Surgical Periodontal Therapy
Non-surgical periodontal therapy consisting of scaling and root planing performed using hand instruments and ultrasonic devices according to standard clinical protocols.
Other Names:
  • Scaling and Root Planing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum TRACP-5b Level
Time Frame: Baseline (pre-intervention) and Month 2 post-treatment
Change in serum tartrate-resistant acid phosphatase 5b (TRACP-5b) levels measured before and after non-surgical periodontal therapy.
Baseline (pre-intervention) and Month 2 post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Probing Depth (PD)
Time Frame: Baseline (pre-intervention) and Month 2 post-treatment
Changes in probing depth measured before and after non-surgical periodontal therapy.
Baseline (pre-intervention) and Month 2 post-treatment
Change in Clinical Attachment Level (CAL)
Time Frame: Baseline (pre-intervention) and Month 2 post-treatment
Changes in clinical attachment level measured before and after non-surgical periodontal therapy.
Baseline (pre-intervention) and Month 2 post-treatment
Change in Plaque Index (PI)
Time Frame: Baseline (pre-intervention) and Month 2 post-treatment
Changes in plaque index measured before and after non-surgical periodontal therapy.
Baseline (pre-intervention) and Month 2 post-treatment
Change in Gingival Index (GI)
Time Frame: Baseline (pre-intervention) and Month 2 post-treatment
Changes in gingival index measured before and after non-surgical periodontal therapy.
Baseline (pre-intervention) and Month 2 post-treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Serum 25-Hydroxyvitamin D Level
Time Frame: Baseline (pre-intervention) and Month 2 post-treatment
Change in serum 25-hydroxyvitamin D levels measured at baseline and after non-surgical periodontal therapy.
Baseline (pre-intervention) and Month 2 post-treatment
Change in Serum Bone Alkaline Phosphatase (BALP) Level
Time Frame: Baseline (pre-intervention) and Month 2 post-treatment
Change in serum bone alkaline phosphatase (BALP) levels measured at baseline and after non-surgical periodontal therapy.
Baseline (pre-intervention) and Month 2 post-treatment

Collaborators and Investigators

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

Sponsor

Ataturk University

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)

December 5, 2024

Primary Completion (Actual)

January 15, 2026

Study Completion (Estimated)

March 15, 2026

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/700

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to patient confidentiality considerations and the single-center design of the study.

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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