Periodontal DiseaseNCT07294105
Relationship Between Periodontal Disease and Postmenopausal Osteoporosis
An observational study of Periodontal Disease and Postmenopausal Osteoporosis (PMO), run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
Elevated sclerostin levels in serum and alveolar bone of osteoporotic patients may exert deleterious effects on the periodontium, thereby contributing to the progression and increased severity of periodontal disease. Read more about this study
- Who is it for?
- Ages 43 to 78 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Postmenopausal Osteoporosis (PMO)
- What is being tested?
- clinical assessment and Radiographic Evaluation
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Nov 2022to 10 May 2023
- How long will I take part?
- 6 Months
- 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 43 to 78 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postmenopausal female patients applying to the Periodontics Clinic of Recep Tayyip Erdoğan University Faculty of Dentistry
Who may be able to join
- Female patients aged 40 years and older in the postmenopausal period,
- Individuals diagnosed with osteoporosis or healthy individuals without osteoporosis, as determined by DXA testing of the hip or spine,
- Individuals who had been postmenopausal for ≥6 months and had not received hormone replacement therapy,
- Patients who did not smoke or consume alcohol,
- Female patients who were periodontally healthy or diagnosed with Stage 2-3, Grade A periodontitis
Who cannot join
- Patients with chronic renal and hepatic insufficiency; malignant diseases such as diabetes mellitus, leukemia, multiple myeloma, and widespread carcinoma; chronic inflammatory rheumatic diseases such as rheumatoid arthritis and ankylosing spondylitis; and those using drugs that may affect bone metabolism (glucocorticoids, heparin, methotrexate, anticonvulsants),
- Those who had received antibiotic therapy in the previous 3 months or any medication for osteoporosis treatment,
- Patients who had undergone surgical or non-surgical periodontal treatment within the previous 6 months,
- Patients who did not wish to continue participation in the study at the midpoint or at the end of the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University
Rize, Rize Province, 53020
About this study
Official title: Investigation of the Relationship Between Periodontal Disease and Serum and Gingival Crevicular Fluid Sclerostin and Tumor Necrosis Factor- α Levels in Women With Postmenopausal Osteoporosis
Elevated sclerostin levels in serum and alveolar bone of osteoporotic patients may exert deleterious effects on the periodontium, thereby contributing to the progression and increased severity of periodontal disease. Moreover, sclerostin is considered a potential biomarker for elucidating the shared pathophysiological mechanisms linking postmenopausal osteoporosis and periodontitis
Read the detailed description
In this study, it has aimed to reveal the relationship between postmenopausal osteoporosis and periodontitis by comparing inflammatory (TNF-α) and bone destruction biomarker (sclerostin) levels in serum and GCF and clinical periodontal parameters in postmenopausal women with decreased BMD. A total of 80 postmenopausal female have included in our study. Patients have divided into 4 groups according to radiological and clinical examination results as control (Group K), periodontitis (Group P), osteoporosis (Group O) and osteoporosis-periodontitis (Group OP). Clinically, PI, GI, BI, PPD and CAL have measured. TNF-α and sclerostin levels have measured by ELISA method in serum and DOS samples. In addition, L1-L4, femoral total and femoral neck BMD values have determined by DXA method. For statistical analyses, Shapiro Wilk test, Mann Whitney U test, Anova test, Kruskal Wallis test, Post Hoc Bonferroni test, Pearson Chi-Square test, Fisher's Exact test, Pearson and Spearman correlation have used. Results: Serum sclerostin level of Group OP and Group P and GCF sclerostin level of Group OP, Group P and Group O have higher than Group K (p<0.05). A positive correlation has found between serum sclerostin level and serum TNF-α (p=0.013, r=0.278) with GCF TNF-α (p=0.001, r=0.356) levels (p<0.05). A positive correlation has found between GCF TNF-α (p=0.002, r=0.334) and GCF sclerostin level (p<0.05).
The increased level of sclerostin in serum and GCF in osteoporosis patients may increase the severity of periodontal disease by creating a destructive effect on the periodontium; It is also thought that it can be used as a biomarker to elucidate the common mechanism in the relationship between postmenopausal osteoporosis and periodontitis.
- Being tested
- clinical assessment, Radiographic Evaluation
- Keywords
- Periodontitis, Postmenopausal osteoporosis, Sclerostin, Tumor necrosis factor
- Medical subject headings
- Periodontal Diseases, Osteoporosis, Postmenopausal, Periodontitis, Sclerosteosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical assessmentOther
Also called Clinical Index and Measurements
The plaque index (PI) is a quantitative measure used to evaluate the presence and amount of dental plaque on tooth surfaces. Her dişin dört yüzeyi incelenir ve plak varlığına göre 0'dan 3'e kadar puanlanır.
Radiographic EvaluationDiagnostic test
Also called Bone Mineral Density Measurements
Bone Mineral Density measurements will perform using the Stratos dR 2D Fan Beam DXA device. L1-L4, femoral neck, and femur total T-score values, as well as BMD (gr/cm3) values, will record for all patients.
clinical assessmentOther
Also called klinik indeksler ve ölçüm
The gingival index (GI) is a clinical parameter that evaluates the degree of gingival inflammation by examining changes in color, texture, and bleeding tendency of the gingiva. Her dişin dört yüzeyi incelenir ve diş eti rengi, ödemi ve kanama durumuna göre 0'dan 3'e kadar puanlanır.
clinical assessmentOther
Also called klinik indeksler ve ölçüm
Sondlamada kanama indeksi diş etlerinin sondlama (periodontal prob ile hafif dokunma) veya fırçalama sonrası kanama eğilimini ölçer. Diş eti dokusundaki inflamasyonun derecesi hakkında bilgi verir. Ainamo \& Bay (1975) - Bleeding on Probing (BOP) Index Periodontal sondun dişeti oluğuna yerleştirilmesinden 10-15 saniye sonra kanama olup olmadığı gözlenir.
clinical assessmentOther
Also called klinik indeksler ve ölçümler
Probing Pocket Depth (PPD), diş ile diş eti arasındaki boşluğun (gingival sulkus veya periodontal cep) diş eti kenarından (gingival margin) cep tabanına (junctional epithelium) kadar olan dikey mesafesidir.
Bu ölçüm, periodontal sond (genellikle milimetrik işaretlere sahip ince metal bir alet) ile yapılır.
clinical assessmentOther
Also called klinik indeksler ve ölçümler
Clinical attachment level measurement diş eti kenarından (gingival margin) değil, mine-sement sınırı (cementoenamel junction - CEJ) ile cep tabanı (junctional epithelium) arasındaki dikey mesafedir.
Bu ölçüm, periodontal destek dokularının kalıcı kaybını gösterir.
| Study group | Role | What they receive |
|---|---|---|
| Group C (Control) | Periodontally and systemically healthy women without osteoporosis (n=20) Receives: Other: clinical assessment; Diagnostic Test: Radiographic Evaluation | |
| Group P (Experimental) | Women with periodontitis and without osteoporosis (n=20) Receives: Other: clinical assessment; Diagnostic Test: Radiographic Evaluation | |
| Group O (Experimental) | Periodontally healthy women with osteoporosis (n = 20) Receives: Other: clinical assessment; Diagnostic Test: Radiographic Evaluation | |
| Group OP (Experimental) | Women with periodontitis and osteoporosis (n = 20) Receives: Other: clinical assessment; Diagnostic Test: Radiographic Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Sample Collection
Venous blood samples will from the left antecubital fossa of the patients
Measured: 6 month
Collection and Quantification of Gingival Crevicular Fluid Samples
Based on the patient's clinical examination status 24 hours after the periodontal clinical measurements, the deepest probable pocket area for individuals with periodontitis, each in six separate quadrants, will sellect for GCF samples. For periodontally healthy individuals, four teeth with a pocket depth of <3 mm, a gingival and plaque index of 0, and no bleeding were selected.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start7 Nov 2022
- Primary completion10 Nov 2022
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- 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
- 80 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mujde Cilkus, Recep Tayyip Erdogan University
- Investigators
- MUJDE CİLKUS, Research Assistant, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294105
- Sponsor's protocol ID
- RecepTayyipErdoganU-DHF-MC-01
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 19 Dec 2025
- 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Periodontal Disease and Serum and Gingival Crevicular Fluid Sclerostin and Tumor Necrosis Factor- α Levels in Women With Postmenopausal Osteoporosis
- ClinicalTrials.gov ID
- NCT07294105
- Acronym / sponsor ID
- RecepTayyipErdoganU-DHF-MC-01
- Keywords
- Periodontitis, Postmenopausal osteoporosis, Sclerostin, Tumor necrosis factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 19 Dec 2025 (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.
Elevated sclerostin levels in serum and alveolar bone of osteoporotic patients may exert deleterious effects on the periodontium, thereby contributing to the progression and increased severity of periodontal disease. Moreover, sclerostin is considered a potential biomarker for elucidating the shared pathophysiological mechanisms linking postmenopausal osteoporosis and periodontitis
Detailed description
In this study, it has aimed to reveal the relationship between postmenopausal osteoporosis and periodontitis by comparing inflammatory (TNF-α) and bone destruction biomarker (sclerostin) levels in serum and GCF and clinical periodontal parameters in postmenopausal women with decreased BMD. A total of 80 postmenopausal female have included in our study. Patients have divided into 4 groups according to radiological and clinical examination results as control (Group K), periodontitis (Group P), osteoporosis (Group O) and osteoporosis-periodontitis (Group OP). Clinically, PI, GI, BI, PPD and CAL have measured. TNF-α and sclerostin levels have measured by ELISA method in serum and DOS samples. In addition, L1-L4, femoral total and femoral neck BMD values have determined by DXA method. For statistical analyses, Shapiro Wilk test, Mann Whitney U test, Anova test, Kruskal Wallis test, Post Hoc Bonferroni test, Pearson Chi-Square test, Fisher's Exact test, Pearson and Spearman correlation have used. Results: Serum sclerostin level of Group OP and Group P and GCF sclerostin level of Group OP, Group P and Group O have higher than Group K (p<0.05). A positive correlation has found between serum sclerostin level and serum TNF-α (p=0.013, r=0.278) with GCF TNF-α (p=0.001, r=0.356) levels (p<0.05). A positive correlation has found between GCF TNF-α (p=0.002, r=0.334) and GCF sclerostin level (p<0.05).
The increased level of sclerostin in serum and GCF in osteoporosis patients may increase the severity of periodontal disease by creating a destructive effect on the periodontium; It is also thought that it can be used as a biomarker to elucidate the common mechanism in the relationship between postmenopausal osteoporosis and periodontitis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group C (Control) | – | Other: clinical assessment, Diagnostic Test: Radiographic EvaluationPeriodontally and systemically healthy women without osteoporosis (n=20) |
| Group P (Experimental) | – | Other: clinical assessment, Diagnostic Test: Radiographic EvaluationWomen with periodontitis and without osteoporosis (n=20) |
| Group O (Experimental) | – | Other: clinical assessment, Diagnostic Test: Radiographic EvaluationPeriodontally healthy women with osteoporosis (n = 20) |
| Group OP (Experimental) | – | Other: clinical assessment, Diagnostic Test: Radiographic EvaluationWomen with periodontitis and osteoporosis (n = 20) |
Who may qualify
- Ages
- 43 to 78 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal female patients applying to the Periodontics Clinic of Recep Tayyip Erdoğan University Faculty of Dentistry
Key inclusion criteria (5 listed)
- Female patients aged 40 years and older in the postmenopausal period,
- Individuals diagnosed with osteoporosis or healthy individuals without osteoporosis, as determined by DXA testing of the hip or spine,
- Individuals who had been postmenopausal for ≥6 months and had not received hormone replacement therapy,
- Patients who did not smoke or consume alcohol,
- Female patients who were periodontally healthy or diagnosed with Stage 2-3, Grade A periodontitis
Key exclusion criteria (4 listed)
- Patients with chronic renal and hepatic insufficiency; malignant diseases such as diabetes mellitus, leukemia, multiple myeloma, and widespread carcinoma; chronic inflammatory rheumatic diseases such as rheumatoid arthritis and ankylosing spondylitis; and those using drugs that may affect bone metabolism (glucocorticoids, heparin, methotrexate, anticonvulsants),
- Those who had received antibiotic therapy in the previous 3 months or any medication for osteoporosis treatment,
- Patients who had undergone surgical or non-surgical periodontal treatment within the previous 6 months,
- Patients who did not wish to continue participation in the study at the midpoint or at the end of the study.
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 |
|---|---|---|
| clinical assessmentAlso: Clinical Index and MeasurementsThe plaque index (PI) is a quantitative measure used to evaluate the presence and amount of dental plaque on tooth surfaces. Her dişin dört yüzeyi incelenir ve plak varlığına göre 0'dan 3'e kadar puanlanır. | Other | Group C (Control), Group O (Experimental), Group OP (Experimental), Group P (Experimental) |
| Radiographic EvaluationAlso: Bone Mineral Density MeasurementsBone Mineral Density measurements will perform using the Stratos dR 2D Fan Beam DXA device. L1-L4, femoral neck, and femur total T-score values, as well as BMD (gr/cm3) values, will record for all patients. | Diagnostic test | Group C (Control), Group O (Experimental), Group OP (Experimental), Group P (Experimental) |
| clinical assessmentAlso: klinik indeksler ve ölçümThe gingival index (GI) is a clinical parameter that evaluates the degree of gingival inflammation by examining changes in color, texture, and bleeding tendency of the gingiva. Her dişin dört yüzeyi incelenir ve diş eti rengi, ödemi ve kanama durumuna göre 0'dan 3'e kadar puanlanır. | Other | Group C (Control), Group O (Experimental), Group OP (Experimental), Group P (Experimental) |
| clinical assessmentAlso: klinik indeksler ve ölçümSondlamada kanama indeksi diş etlerinin sondlama (periodontal prob ile hafif dokunma) veya fırçalama sonrası kanama eğilimini ölçer. Diş eti dokusundaki inflamasyonun derecesi hakkında bilgi verir. Ainamo \& Bay (1975) - Bleeding on Probing (BOP) Index Periodontal sondun dişeti oluğuna yerleştirilmesinden 10-15 saniye sonra kanama olup olmadığı gözlenir. | Other | Group C (Control), Group O (Experimental), Group OP (Experimental), Group P (Experimental) |
| clinical assessmentAlso: klinik indeksler ve ölçümlerProbing Pocket Depth (PPD), diş ile diş eti arasındaki boşluğun (gingival sulkus veya periodontal cep) diş eti kenarından (gingival margin) cep tabanına (junctional epithelium) kadar olan dikey mesafesidir. Bu ölçüm, periodontal sond (genellikle milimetrik işaretlere sahip ince metal bir alet) ile yapılır. | Other | Group C (Control), Group O (Experimental), Group OP (Experimental), Group P (Experimental) |
| clinical assessmentAlso: klinik indeksler ve ölçümlerClinical attachment level measurement diş eti kenarından (gingival margin) değil, mine-sement sınırı (cementoenamel junction - CEJ) ile cep tabanı (junctional epithelium) arasındaki dikey mesafedir. Bu ölçüm, periodontal destek dokularının kalıcı kaybını gösterir. | Other | Group C (Control), Group O (Experimental), Group OP (Experimental), Group P (Experimental) |
Primary outcome
Serum Sample Collection
Time frame: 6 month
Venous blood samples will from the left antecubital fossa of the patients
Collection and Quantification of Gingival Crevicular Fluid Samples
Time frame: 6 month
Based on the patient's clinical examination status 24 hours after the periodontal clinical measurements, the deepest probable pocket area for individuals with periodontitis, each in six separate quadrants, will sellect for GCF samples. For periodontally healthy individuals, four teeth with a pocket depth of <3 mm, a gingival and plaque index of 0, and no bleeding were selected.
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 19 Dec 2025.
- 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.
MUJDE CİLKUS, Research Assistant principal investigator
Recep Tayyip Erdogan University
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 Periodontal Disease and Postmenopausal Osteoporosis (PMO), run by Recep Tayyip Erdogan 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 4 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 19 Dec 2025. 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?
Serum Sample Collection (time frame: 6 month). The study lists 2 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 19 Dec 2025.