Stage III PeriodontitisTRACP-BALP-D3NCT07438977
Evaluation of Serum TRACP-5b, BALP, and 25-Hydroxyvitamin D3 Levels in Stage III Periodontitis Patients
A study testing Non-Surgical Periodontal Therapy in people with Stage III Periodontitis, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stage III Periodontitis
- What is being tested?
- Non-Surgical Periodontal Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2024to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Faculty of Dentistry
Erzurum, Erzurum
About this study
Official 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
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.
Read more
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.
Read the 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.
- Conditions
- Stage III Periodontitis
- Being tested
- Non-Surgical Periodontal Therapy
- Keywords
- Stage III periodontitis, Non-surgical periodontal therapy, Scaling and root planing, TRACP-5b, Bone alkaline phosphatase, Bone metabolism, 25-hydroxyvitamin D
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Surgical Periodontal TherapyProcedure or surgery
Also called Scaling and Root Planing
Non-surgical periodontal therapy consisting of scaling and root planing performed using hand instruments and ultrasonic devices according to standard clinical protocols.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Non-Surgical Periodontal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-intervention) and Month 2 post-treatment
Secondary outcomes (4)
Change in Probing Depth (PD)
Changes in probing depth measured before and after non-surgical periodontal therapy.
Measured: Baseline (pre-intervention) and Month 2 post-treatment
Change in Clinical Attachment Level (CAL)
Changes in clinical attachment level measured before and after non-surgical periodontal therapy.
Measured: Baseline (pre-intervention) and Month 2 post-treatment
Change in Plaque Index (PI)
Changes in plaque index measured before and after non-surgical periodontal therapy.
Measured: Baseline (pre-intervention) and Month 2 post-treatment
Change in Sulcus Bleeding Index (SBI)
Changes 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.
Measured: Baseline (pre-intervention) and Month 2 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start5 Dec 2024
- Primary completion15 Jan 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Aydin, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438977
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/700
- Acronym
- TRACP-BALP-D3
- Status last verified
- Aug 2026
- First submitted
- 22 Dec 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality considerations and the single-center design of the study.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07438977
- Acronym / sponsor ID
- TRACP-BALP-D3 / B.30.2.ATA.0.01.00/700
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Non-Surgical Periodontal Therapy | Experimental | Procedure: Non-Surgical Periodontal TherapyParticipants with Stage III periodontitis receive non-surgical periodontal therapy consisting of scaling and root planing performed according to standard clinical protocols. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Surgical Periodontal TherapyAlso: Scaling and Root PlaningNon-surgical periodontal therapy consisting of scaling and root planing performed using hand instruments and ultrasonic devices according to standard clinical protocols. | Procedure or surgery | Non-Surgical Periodontal Therapy |
Primary outcome
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.
4 secondary outcomes
Change in Probing Depth (PD)
Time frame: Baseline (pre-intervention) and Month 2 post-treatment
Change in Clinical Attachment Level (CAL)
Time frame: Baseline (pre-intervention) and Month 2 post-treatment
Change in Plaque Index (PI)
Time frame: Baseline (pre-intervention) and Month 2 post-treatment
Change in Sulcus Bleeding Index (SBI)
Time frame: Baseline (pre-intervention) and Month 2 post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality considerations and the single-center design of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Surgical Periodontal Therapy in people with Stage III Periodontitis, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum TRACP-5b Level (time frame: Baseline (pre-intervention) and Month 2 post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.