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NCT Number: NCT07438977

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Stage III Periodontitis Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University Faculty of Dentistry

Erzurum, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Non-surgical periodontal therapy

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Acronym: TRACP-BALP-D3

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 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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