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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07438977
Acronym
TRACP-BALP-D3
Enrollment
16
Registered
2026-02-27
Start date
2024-12-05
Completion date
2026-05-15
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

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.

Interventions

PROCEDURENon-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.

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Serum TRACP-5b LevelBaseline (pre-intervention) and Month 2 post-treatmentChange in serum tartrate-resistant acid phosphatase 5b (TRACP-5b) levels measured before and after non-surgical periodontal therapy.

Secondary

MeasureTime frameDescription
Change in Probing Depth (PD)Baseline (pre-intervention) and Month 2 post-treatmentChanges in probing depth measured before and after non-surgical periodontal therapy.
Change in Clinical Attachment Level (CAL)Baseline (pre-intervention) and Month 2 post-treatmentChanges in clinical attachment level measured before and after non-surgical periodontal therapy.
Change in Plaque Index (PI)Baseline (pre-intervention) and Month 2 post-treatmentChanges in plaque index measured before and after non-surgical periodontal therapy.
Change in Sulcus Bleeding Index (SBI)Baseline (pre-intervention) and Month 2 post-treatmentChanges in the Sulcus Bleeding Index (SBI) before and after non-surgical periodontal therapy. Bleeding was recorded dichotomously as present (+) or absent (-) at each assessed site and expressed as the percentage of sites showing bleeding. Values range from 0% to 100%, with higher percentages indicating greater gingival bleeding and a worse periodontal outcome.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026