Periodontitis (Stage 3)GPNMB-PERIO StNCT07475013
Effects of Non-Surgical Periodontal Treatment on Inflammatory and Bone Markers in Periodontitis Patients
A study testing Scaling and Root Planing (SRP) in people with Periodontitis (Stage 3), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to learn how a standard treatment called Scaling and Root Planing (SRP) affects specific biochemical markers in people with advanced gum disease (periodontitis). Periodontitis is a chronic condition that can lead to tooth loss. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis (Stage 3)
- What is being tested?
- Scaling and Root Planing (SRP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically healthy individuals
- Individuals diagnosed with Stage III Grade B or Grade C periodontitis (for the periodontitis group)
- Periodontally healthy individuals (for the healthy control group)
- Participants aged 18 years and older
Who cannot join
- Individuals who have received periodontal treatment within the last 6 months
- Individuals who have used antibacterial drugs within the last 6 months
- Individuals with any systemic disease
- Individuals who use medications on a regular basis
- Current smokers
- Pregnant individuals
- Participants under the age of 18 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi
Ankara, 06010
About this study
Official title: Evaluation of the Effects of Non-Surgical Periodontal Therapy on Serum and Gingival Crevicular Fluid Levels of Glycoprotein Non-Metastatic B (GPNMB), TGF-β1, RANKL, and Osteoprotegerin in Patients With Periodontitis
The goal of this study is to learn how a standard treatment called Scaling and Root Planing (SRP) affects specific biochemical markers in people with advanced gum disease (periodontitis). Periodontitis is a chronic condition that can lead to tooth loss.
The main focus is to investigate a marker called Glycoprotein Non-Metastatic B (GPNMB). This is the first study to examine GPNMB levels in both the serum and the gingival crevicular fluid of people with this condition. The study aims to answer these main questions:
Read more
How do GPNMB levels change after the Scaling and Root Planing treatment?
How does GPNMB relate to other markers that control bone health and healing, such as TGF-β1, RANKL, and Osteoprotegerin?
Researchers will compare 28 participants with advanced gum disease (Stage III Grade B/C) to 28 participants with healthy gums to see how these markers differ.
Participants in the gum disease group will:
Provide samples for laboratory analysis at the start of the study.
Receive the standard mechanical treatment of their teeth and roots (Scaling and Root Planing).
Return for follow-up visits 6 weeks and 3 months after treatment to provide new samples and have their gum health checked.
- Conditions
- Periodontitis (Stage 3)
- Being tested
- Scaling and Root Planing (SRP)
- Keywords
- TGF-beta1, GPNMB, RANKL, OPG, Periodontitis, non-surgical periodontal treatment
- Medical subject headings
- Periodontitis, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and Root Planing (SRP)Procedure or surgery
A standard non-surgical mechanical treatment that involves the removal of plaque and calculus from the teeth and root surfaces using ultrasonic devices and hand instruments.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis Group | Experimental | Participants with Stage III Grade B/C periodontitis. At baseline, clinical periodontal measurements are recorded, and serum and gingival crevicular fluid samples are collected. All participants receive non-surgical periodontal therapy consisting of Scaling and Root Planing (SRP). Follow-up visits are conducted at 6 weeks and 3 months post-treatment for repeated clinical assessments and sample collection to evaluate changes in biochemical markers (GPNMB, TGF-β1, RANKL, and OPG). Receives: Procedure: Scaling and Root Planing (SRP) |
| Healthy Control Group | No intervention | Periodontally healthy individuals. Participants undergo a single clinical periodontal examination and provide serum and gingival crevicular fluid samples at the baseline visit. This group serves as a reference for baseline biochemical marker levels. No therapeutic intervention is performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gingival Crevicular Fluid (GCF) Glycoprotein Non-Metastatic B (GPNMB) Concentration
Concentration of GPNMB in gingival crevicular fluid samples measured by Enzyme-Linked Immunosorbent Assay (ELISA). Results will be expressed in picograms per microliter (pg/µL) to evaluate the local biochemical response following scaling and root planing (SRP).
Measured: Baseline, 6 weeks, and 3 months post-treatment.
Change in Serum Glycoprotein Non-Metastatic B (GPNMB) Concentration
Concentration of GPNMB in serum samples measured by Enzyme-Linked Immunosorbent Assay (ELISA) to evaluate the systemic biochemical response. The results will be quantified and reported in picograms per milliliter (pg/mL) to evaluate the change in mean concentration values across the specified measurement intervals.
Measured: Baseline, 6 weeks post-treatment, and 3 months post-treatment.
Change in Gingival Crevicular Fluid (GCF) Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) Concentration
Concentration of RANKL in gingival crevicular fluid samples measured via ELISA to assess local bone resorption activity. The data will be quantified in picograms per microliter (pg/µL) at baseline and post-treatment intervals.
Measured: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Serum Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) Concentration
Concentration of RANKL in serum samples measured by ELISA to evaluate the systemic bone resorption activity. The results will be quantified and reported in picograms per milliliter (pg/mL) to evaluate the change in mean concentration values across the specified measurement intervals following periodontal therapy.
Measured: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Gingival Crevicular Fluid (GCF) Osteoprotegerin (OPG) Concentration
Concentration of OPG in gingival crevicular fluid samples measured by ELISA to assess the local bone-protective response. The results will be quantified and reported in picograms per microliter (pg/µL) to evaluate the change in mean concentration values across the specified measurement intervals following scaling and root planing (SRP).
Measured: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Serum Osteoprotegerin (OPG) Concentration
Concentration of OPG in serum samples measured by ELISA to evaluate the systemic bone-protective response. Measurement values will be reported in picograms per milliliter (pg/mL) to compare the changes in mean concentration values across the specified measurement intervals following periodontal therapy.
Measured: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Gingival Crevicular Fluid (GCF) Transforming Growth Factor beta 1 (TGF-β1) Concentration
Concentration of TGF-β1 in gingival crevicular fluid samples measured by Enzyme-Linked Immunosorbent Assay (ELISA). This analysis evaluates the local anti-inflammatory response and tissue healing following scaling and root planing (SRP). The results will be quantified and reported in picograms per microliter (pg/µL) to evaluate the change in mean concentration values across the specified measurement intervals.
Measured: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Serum Transforming Growth Factor beta 1 (TGF-β1) Concentration
Concentration of TGF-β1 in serum samples measured by ELISA to evaluate the systemic anti-inflammatory response. Measurement values will be reported in picograms per milliliter (pg/mL) to compare the changes before and after scaling and root planing (SRP).
Measured: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Secondary outcomes (4)
Change in Probing Pocket Depth (PPD)
Probing Pocket Depth (PPD) will be measured at six sites per tooth using a Williams periodontal probe to evaluate the depth of the periodontal pockets.
Measured: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Clinical Attachment Loss (CAL)
Clinical Attachment Loss (CAL) will be measured at six sites per tooth using a Williams periodontal probe to assess the level of periodontal tissue attachment.
Measured: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Plaque Index (PI)
Plaque Index (PI) will be used to assess the amount of plaque on the tooth surfaces to evaluate oral hygiene status.
Measured: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Gingival Index (GI)
Gingival Index (GI) will be used to assess the severity of gingival inflammation based on color, consistency, and bleeding tendency.
Measured: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start15 Mar 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis (Stage 3)Studies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem SARAÇ ATAGÜN, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475013
- Sponsor's protocol ID
- OSATAGUN5
- Acronym
- GPNMB-PERIO St
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 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 and Gingival Crevicular Fluid Levels of Glycoprotein Non-Metastatic B (GPNMB), TGF-β1, RANKL, and Osteoprotegerin in Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT07475013
- Acronym / sponsor ID
- GPNMB-PERIO St / OSATAGUN5
- Conditions
- Periodontitis (Stage 3)
- Keywords
- TGF-beta1, GPNMB, RANKL, OPG, Periodontitis, non-surgical periodontal treatment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Mar 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.
The goal of this study is to learn how a standard treatment called Scaling and Root Planing (SRP) affects specific biochemical markers in people with advanced gum disease (periodontitis). Periodontitis is a chronic condition that can lead to tooth loss.
The main focus is to investigate a marker called Glycoprotein Non-Metastatic B (GPNMB). This is the first study to examine GPNMB levels in both the serum and the gingival crevicular fluid of people with this condition. The study aims to answer these main questions:
How do GPNMB levels change after the Scaling and Root Planing treatment?
How does GPNMB relate to other markers that control bone health and healing, such as TGF-β1, RANKL, and Osteoprotegerin?
Researchers will compare 28 participants with advanced gum disease (Stage III Grade B/C) to 28 participants with healthy gums to see how these markers differ.
Participants in the gum disease group will:
Provide samples for laboratory analysis at the start of the study.
Receive the standard mechanical treatment of their teeth and roots (Scaling and Root Planing).
Return for follow-up visits 6 weeks and 3 months after treatment to provide new samples and have their gum health checked.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis Group | Experimental | Procedure: Scaling and Root Planing (SRP)Participants with Stage III Grade B/C periodontitis. At baseline, clinical periodontal measurements are recorded, and serum and gingival crevicular fluid samples are collected. All participants receive non-surgical periodontal therapy consisting of Scaling and Root Planing (SRP). Follow-up visits are conducted at 6 weeks and 3 months post-treatment for repeated clinical assessments and sample collection to evaluate changes in biochemical markers (GPNMB, TGF-β1, RANKL, and OPG). |
| Healthy Control Group | No intervention | –Periodontally healthy individuals. Participants undergo a single clinical periodontal examination and provide serum and gingival crevicular fluid samples at the baseline visit. This group serves as a reference for baseline biochemical marker levels. No therapeutic intervention is performed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Systemically healthy individuals
- Individuals diagnosed with Stage III Grade B or Grade C periodontitis (for the periodontitis group)
- Periodontally healthy individuals (for the healthy control group)
- Participants aged 18 years and older
Key exclusion criteria (7 listed)
- Individuals who have received periodontal treatment within the last 6 months
- Individuals who have used antibacterial drugs within the last 6 months
- Individuals with any systemic disease
- Individuals who use medications on a regular basis
- Current smokers
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 |
|---|---|---|
| Scaling and Root Planing (SRP)A standard non-surgical mechanical treatment that involves the removal of plaque and calculus from the teeth and root surfaces using ultrasonic devices and hand instruments. | Procedure or surgery | Periodontitis Group |
Primary outcome
Change in Gingival Crevicular Fluid (GCF) Glycoprotein Non-Metastatic B (GPNMB) Concentration
Time frame: Baseline, 6 weeks, and 3 months post-treatment.
Concentration of GPNMB in gingival crevicular fluid samples measured by Enzyme-Linked Immunosorbent Assay (ELISA). Results will be expressed in picograms per microliter (pg/µL) to evaluate the local biochemical response following scaling and root planing (SRP).
Change in Serum Glycoprotein Non-Metastatic B (GPNMB) Concentration
Time frame: Baseline, 6 weeks post-treatment, and 3 months post-treatment.
Concentration of GPNMB in serum samples measured by Enzyme-Linked Immunosorbent Assay (ELISA) to evaluate the systemic biochemical response. The results will be quantified and reported in picograms per milliliter (pg/mL) to evaluate the change in mean concentration values across the specified measurement intervals.
Change in Gingival Crevicular Fluid (GCF) Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) Concentration
Time frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Concentration of RANKL in gingival crevicular fluid samples measured via ELISA to assess local bone resorption activity. The data will be quantified in picograms per microliter (pg/µL) at baseline and post-treatment intervals.
Change in Serum Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) Concentration
Time frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Concentration of RANKL in serum samples measured by ELISA to evaluate the systemic bone resorption activity. The results will be quantified and reported in picograms per milliliter (pg/mL) to evaluate the change in mean concentration values across the specified measurement intervals following periodontal therapy.
Change in Gingival Crevicular Fluid (GCF) Osteoprotegerin (OPG) Concentration
Time frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Concentration of OPG in gingival crevicular fluid samples measured by ELISA to assess the local bone-protective response. The results will be quantified and reported in picograms per microliter (pg/µL) to evaluate the change in mean concentration values across the specified measurement intervals following scaling and root planing (SRP).
Change in Serum Osteoprotegerin (OPG) Concentration
Time frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Concentration of OPG in serum samples measured by ELISA to evaluate the systemic bone-protective response. Measurement values will be reported in picograms per milliliter (pg/mL) to compare the changes in mean concentration values across the specified measurement intervals following periodontal therapy.
Change in Gingival Crevicular Fluid (GCF) Transforming Growth Factor beta 1 (TGF-β1) Concentration
Time frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Concentration of TGF-β1 in gingival crevicular fluid samples measured by Enzyme-Linked Immunosorbent Assay (ELISA). This analysis evaluates the local anti-inflammatory response and tissue healing following scaling and root planing (SRP). The results will be quantified and reported in picograms per microliter (pg/µL) to evaluate the change in mean concentration values across the specified measurement intervals.
Change in Serum Transforming Growth Factor beta 1 (TGF-β1) Concentration
Time frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Concentration of TGF-β1 in serum samples measured by ELISA to evaluate the systemic anti-inflammatory response. Measurement values will be reported in picograms per milliliter (pg/mL) to compare the changes before and after scaling and root planing (SRP).
4 secondary outcomes
Change in Probing Pocket Depth (PPD)
Time frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Clinical Attachment Loss (CAL)
Time frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Plaque Index (PI)
Time frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Change in Gingival Index (GI)
Time frame: Baseline (before treatment), 6 weeks post-treatment, and 3 months post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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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 Scaling and Root Planing (SRP) in people with Periodontitis (Stage 3), run by Saglik Bilimleri Universitesi 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 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?
This study is still under way. Results are not available in the source record yet.
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 Gingival Crevicular Fluid (GCF) Glycoprotein Non-Metastatic B (GPNMB) Concentration (time frame: Baseline, 6 weeks, and 3 months post-treatment.). The study lists 8 primary outcomes in all. 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 27 Apr 2026.