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

NCT07438977 | Active Not Recruiting

• 1 other identifier: B.30.2.ATA.0.01.00/700
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stage III Periodontitis

Keywords

Stage III periodontitis; Non-surgical periodontal therapy; Scaling and root planing; TRACP-5b; Bone alkaline phosphatase; Bone metabolism; 25-hydroxyvitamin D

Outcome Measures

Primary Outcomes (1)

• Change in Serum TRACP-5b Level

  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 Outcomes (4)

• Change in Probing Depth (PD)

  Baseline (pre-intervention) and Month 2 post-treatment

• Change in Clinical Attachment Level (CAL)

  Baseline (pre-intervention) and Month 2 post-treatment

• Change in Plaque Index (PI)

  Baseline (pre-intervention) and Month 2 post-treatment

• Change in Gingival Index (GI)

  Baseline (pre-intervention) and Month 2 post-treatment

Other Outcomes (2)

• Changes in Serum 25-Hydroxyvitamin D Level

  Baseline (pre-intervention) and Month 2 post-treatment

• Change in Serum Bone Alkaline Phosphatase (BALP) Level

  Baseline (pre-intervention) and Month 2 post-treatment

Study Arms (1)

Non-Surgical Periodontal Therapy

EXPERIMENTAL

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

Interventions

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.

Also known as: Scaling and Root Planing

Non-Surgical Periodontal Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University Faculty of Dentistry

Erzurum, Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study uses a single-group, pre-post interventional design in which all participants receive non-surgical periodontal therapy, and clinical and biochemical outcomes are evaluated before and after treatment.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: February 27, 2026
• Study Start: December 5, 2024
• Primary Completion: January 15, 2026
• Study Completion: March 15, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)