PeriodontitisNCT07793370
Evaluation of PTHrP, RANKL, and OPG Levels in Periodontal Health and Diseases
An observational study of Periodontitis and Gingivitis, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to evaluate the levels of specific biological markers-Parathyroid Hormone-Related Protein (PTHrP), RANKL, and Osteoprotegerin (OPG)-in the gingival crevicular fluid of individuals with different gum health conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis, Periodontal Disease
- What is being tested?
- Routine periodontal clinical examination and GCF collection
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 20 Aug 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of adult individuals seeking dental care at the Department of Periodontology, Faculty of Dentistry, Bolu Abant Izzet Baysal University. The population includes a total of 81 participants representing three distinct periodontal conditions: individuals with a healthy periodontium, individuals diagnosed with gingivitis, and individuals diagnosed with Stage III periodontitis.
Who may be able to join
- Individuals aged 18 years and older.
- Presence of at least 20 natural teeth, excluding third molars.
- For the Periodontally Healthy GrouP: PD ≤ 3 mm, BOP < 10%, and no interproximal CAL or RBL.
- For the Gingivitis Group: PD ≤ 3 mm, BOP ≥ 30%, and no interproximal CAL or RBL.
- For the Periodontitis Group: Diagnosed with Stage III periodontitis (interproximal CAL ≥ 5 mm, PD ≥ 6 mm, and RBL extending to the middle third of the root or more apically).
Who cannot join
- Presence of systemic diseases that may affect periodontal tissues (e.g., cardiovascular diseases, atherosclerosis, immune system diseases, rheumatoid arthritis, obesity, cancer, and diabetes).
- Use of antibiotics within the last 3 months.
- Use of any medication that may affect periodontal tissues.
- Presence of infectious diseases such as HIV, HBV, or tuberculosis.
- Pregnancy or lactation.
- History of periodontal treatment within the last 6 months.
- Smoking
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant İzzet Baysal University, Faculty of Dentistry, Department of Periodontology
Bolu, Gölköy, 14030
About this study
Official title: Evaluation of Gingival Crevicular Fluid Parathyroid Hormone-Related Protein (PTHrP), RANKL, and OPG Levels in Periodontal Health, Gingivitis, and Periodontitis.
This observational study aims to evaluate the levels of specific biological markers-Parathyroid Hormone-Related Protein (PTHrP), RANKL, and Osteoprotegerin (OPG)-in the gingival crevicular fluid of individuals with different gum health conditions. The study includes a total of 81 participants, divided equally into three groups: 27 with healthy gums, 27 with gingivitis, and 27 with periodontitis. During a routine dental visit, participants undergo a standard periodontal examination to measure clinical signs such as plaque levels, gum bleeding, and pocket depths. Additionally, small sterile paper strips are gently placed in the gum crevices for 30 seconds to collect fluid samples. These fluid samples are then analyzed in a laboratory to understand how these specific proteins relate to gum health and the severity of gum disease.
Read the detailed description
Periodontitis is a chronic inflammatory disease characterized by the destruction of tooth-supporting tissues and alveolar bone loss, primarily driven by an imbalance in bone metabolism. The regulation of bone turnover relies heavily on the balance between RANKL, which promotes osteoclast activation, and OPG, its natural inhibitor. Furthermore, PTHrP acts as a critical autocrine and paracrine regulator in periodontal tissue health and alveolar bone repair. The primary rationale of this research is to investigate the dynamic role of PTHrP in periodontal pathogenesis during both the inflammatory and tissue-destruction phases, evaluating its potential as a biological marker. Following a comprehensive clinical periodontal examination by a single calibrated clinician, specific sampling sites are isolated with cotton rolls and gently air-dried. Supragingival plaque is carefully removed prior to sampling. Gingival crevicular fluid (GCF) is then collected from these designated interproximal sites using sterile filter paper strips, which are inserted into the sulcus until mild resistance is felt and left in place for 30 seconds. Samples contaminated with blood or saliva are immediately excluded. The exact volume of the collected fluid is quantified using an electronic volume meter (Periotron 8010). All valid strips are subsequently transferred to microcentrifuge tubes and preserved at -80°C until laboratory processing. The biochemical quantification of PTHrP, RANKL, and OPG levels is performed via commercially available Enzyme-Linked Immunosorbent Assay (ELISA) kits in accordance with the manufacturer's protocols.
- Conditions
- Periodontitis, Gingivitis, Periodontal Disease
- Being tested
- Routine periodontal clinical examination and GCF collection
- Keywords
- Parathyroid Hormone-Related Protein, RANK Ligand, Osteoprotegerin, Gingival Crevicular Fluid, Biomarkers
- Medical subject headings
- Periodontitis, Gingivitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine periodontal clinical examination and GCF collectionOther
A comprehensive clinical periodontal examination is performed by a single calibrated examiner using a periodontal probe. The examination includes the measurement of Plaque Index (PI), Gingival Index (GI), PD, and CAL. For GCF collection, the specified interproximal sites are isolated with cotton rolls, gently air-dried, and cleared of supragingival plaque. GCF samples are then collected using sterile filter paper strips inserted into the sulcus until mild resistance is felt and left in place for 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Periodontally Healthy | 27 individuals with probing depth (PD) ≤ 3 mm, bleeding on probing (BOP) < 10%, and no interproximal clinical attachment loss (CAL) or radiographic bone loss (RBL). Receives: Other: Routine periodontal clinical examination and GCF collection | |
| Gingivitis | 27 individuals with PD ≤ 3 mm, BOP ≥ 30%, and no CAL or RBL. Receives: Other: Routine periodontal clinical examination and GCF collection | |
| Periodontitis | 27 individuals diagnosed with Stage III periodontitis, characterized by interproximal CAL ≥ 5 mm, PD ≥ 6 mm, and RBL extending to the middle third of the root or more apically. Receives: Other: Routine periodontal clinical examination and GCF collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCF Level of PTHrP
The concentration of PTHrP in GCF samples will be quantitatively measured using commercial ELISA kits.
Measured: Baseline (Single time point during the clinical examination)
GCF Level of RANKL
The concentration of RANKL in GCF samples will be quantitatively measured using commercial ELISA kits.
Measured: Baseline (Single time point during the clinical examination)
GCF Level of Osteoprotegerin
The concentration of OPG in GCF samples will be quantitatively measured using commercial ELISA kits.
Measured: Baseline (Single time point during the clinical examination)
Secondary outcomes (4)
Probing Depth (PD)
PD will be measured using a periodontal probe at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiopalatal/lingual, midpalatal/lingual, and distopalatal/lingual). Measurements will be rounded to the nearest millimeter.
Measured: Baseline (Single time point during the clinical examination)
Clinical Attachment Level (CAL)
CAL will be calculated by measuring the distance from the cementoenamel junction to the base of the probable pocket using a periodontal probe.
Measured: Baseline (Single time point during the clinical examination)
Gingival Index (GI)
GI will be evaluated according to the method described by Löe and Silness. Four surfaces of each tooth (buccal, lingual/palatal, mesial, and distal) will be scored to calculate the full-mouth average GI score.
Measured: Baseline (Single time point during the clinical examination)
Plaque Index (PI)
PI will be evaluated according to the method described by Löe and Silness. Four surfaces of each tooth will be scored to calculate the full-mouth average PI score.
Measured: Baseline (Single time point during the clinical examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Jun 2026
- Primary completion24 Jul 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge MERACI YILDIRAN, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793370
- Sponsor's protocol ID
- BAIBU-SBF-BMY-03
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 30 Oct 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gingival Crevicular Fluid Parathyroid Hormone-Related Protein (PTHrP), RANKL, and OPG Levels in Periodontal Health, Gingivitis, and Periodontitis.
- ClinicalTrials.gov ID
- NCT07793370
- Acronym / sponsor ID
- BAIBU-SBF-BMY-03
- Conditions
- Periodontitis, Gingivitis, Periodontal Disease
- Keywords
- Parathyroid Hormone-Related Protein, RANK Ligand, Osteoprotegerin, Gingival Crevicular Fluid, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 28 Aug 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.
This observational study aims to evaluate the levels of specific biological markers-Parathyroid Hormone-Related Protein (PTHrP), RANKL, and Osteoprotegerin (OPG)-in the gingival crevicular fluid of individuals with different gum health conditions. The study includes a total of 81 participants, divided equally into three groups: 27 with healthy gums, 27 with gingivitis, and 27 with periodontitis. During a routine dental visit, participants undergo a standard periodontal examination to measure clinical signs such as plaque levels, gum bleeding, and pocket depths. Additionally, small sterile paper strips are gently placed in the gum crevices for 30 seconds to collect fluid samples. These fluid samples are then analyzed in a laboratory to understand how these specific proteins relate to gum health and the severity of gum disease.
Detailed description
Periodontitis is a chronic inflammatory disease characterized by the destruction of tooth-supporting tissues and alveolar bone loss, primarily driven by an imbalance in bone metabolism. The regulation of bone turnover relies heavily on the balance between RANKL, which promotes osteoclast activation, and OPG, its natural inhibitor. Furthermore, PTHrP acts as a critical autocrine and paracrine regulator in periodontal tissue health and alveolar bone repair. The primary rationale of this research is to investigate the dynamic role of PTHrP in periodontal pathogenesis during both the inflammatory and tissue-destruction phases, evaluating its potential as a biological marker. Following a comprehensive clinical periodontal examination by a single calibrated clinician, specific sampling sites are isolated with cotton rolls and gently air-dried. Supragingival plaque is carefully removed prior to sampling. Gingival crevicular fluid (GCF) is then collected from these designated interproximal sites using sterile filter paper strips, which are inserted into the sulcus until mild resistance is felt and left in place for 30 seconds. Samples contaminated with blood or saliva are immediately excluded. The exact volume of the collected fluid is quantified using an electronic volume meter (Periotron 8010). All valid strips are subsequently transferred to microcentrifuge tubes and preserved at -80°C until laboratory processing. The biochemical quantification of PTHrP, RANKL, and OPG levels is performed via commercially available Enzyme-Linked Immunosorbent Assay (ELISA) kits in accordance with the manufacturer's protocols.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontally Healthy | – | Other: Routine periodontal clinical examination and GCF collection27 individuals with probing depth (PD) ≤ 3 mm, bleeding on probing (BOP) < 10%, and no interproximal clinical attachment loss (CAL) or radiographic bone loss (RBL). |
| Gingivitis | – | Other: Routine periodontal clinical examination and GCF collection27 individuals with PD ≤ 3 mm, BOP ≥ 30%, and no CAL or RBL. |
| Periodontitis | – | Other: Routine periodontal clinical examination and GCF collection27 individuals diagnosed with Stage III periodontitis, characterized by interproximal CAL ≥ 5 mm, PD ≥ 6 mm, and RBL extending to the middle third of the root or more apically. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult individuals seeking dental care at the Department of Periodontology, Faculty of Dentistry, Bolu Abant Izzet Baysal University. The population includes a total of 81 participants representing three distinct periodontal conditions: individuals with a healthy periodontium, individuals diagnosed with gingivitis, and individuals diagnosed with Stage III periodontitis.
Key inclusion criteria (5 listed)
- Individuals aged 18 years and older.
- Presence of at least 20 natural teeth, excluding third molars.
- For the Periodontally Healthy GrouP: PD ≤ 3 mm, BOP < 10%, and no interproximal CAL or RBL.
- For the Gingivitis Group: PD ≤ 3 mm, BOP ≥ 30%, and no interproximal CAL or RBL.
- For the Periodontitis Group: Diagnosed with Stage III periodontitis (interproximal CAL ≥ 5 mm, PD ≥ 6 mm, and RBL extending to the middle third of the root or more apically).
Key exclusion criteria (7 listed)
- Presence of systemic diseases that may affect periodontal tissues (e.g., cardiovascular diseases, atherosclerosis, immune system diseases, rheumatoid arthritis, obesity, cancer, and diabetes).
- Use of antibiotics within the last 3 months.
- Use of any medication that may affect periodontal tissues.
- Presence of infectious diseases such as HIV, HBV, or tuberculosis.
- Pregnancy or lactation.
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 |
|---|---|---|
| Routine periodontal clinical examination and GCF collectionA comprehensive clinical periodontal examination is performed by a single calibrated examiner using a periodontal probe. The examination includes the measurement of Plaque Index (PI), Gingival Index (GI), PD, and CAL. For GCF collection, the specified interproximal sites are isolated with cotton rolls, gently air-dried, and cleared of supragingival plaque. GCF samples are then collected using sterile filter paper strips inserted into the sulcus until mild resistance is felt and left in place for 30 seconds. | Other | Gingivitis, Periodontally Healthy, Periodontitis |
Primary outcome
GCF Level of PTHrP
Time frame: Baseline (Single time point during the clinical examination)
The concentration of PTHrP in GCF samples will be quantitatively measured using commercial ELISA kits.
GCF Level of RANKL
Time frame: Baseline (Single time point during the clinical examination)
The concentration of RANKL in GCF samples will be quantitatively measured using commercial ELISA kits.
GCF Level of Osteoprotegerin
Time frame: Baseline (Single time point during the clinical examination)
The concentration of OPG in GCF samples will be quantitatively measured using commercial ELISA kits.
4 secondary outcomes
Probing Depth (PD)
Time frame: Baseline (Single time point during the clinical examination)
Clinical Attachment Level (CAL)
Time frame: Baseline (Single time point during the clinical examination)
Gingival Index (GI)
Time frame: Baseline (Single time point during the clinical examination)
Plaque Index (PI)
Time frame: Baseline (Single time point during the clinical examination)
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 30 Oct 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?
An observational study of Periodontitis and Gingivitis, run by Abant Izzet Baysal 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 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: finished, as of the sponsor's last update on 30 Oct 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?
GCF Level of PTHrP (time frame: Baseline (Single time point during the clinical examination)). The study lists 3 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 30 Oct 2026.