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Relationship Between Periodontal Disease and Postmenopausal Osteoporosis

NCT ID: NCT07294105

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-07

Study Completion Date

2023-05-10

Brief Summary

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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

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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.

Conditions

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Periodontal Disease Postmenopausal Osteoporosis (PMO)

Keywords

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Periodontitis Postmenopausal osteoporosis Sclerostin Tumor necrosis factor

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group C (Control)

Periodontally and systemically healthy women without osteoporosis (n=20)

clinical assessment

Intervention Type OTHER

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 Evaluation

Intervention Type DIAGNOSTIC_TEST

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 assessment

Intervention Type OTHER

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 assessment

Intervention Type OTHER

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 assessment

Intervention Type OTHER

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 assessment

Intervention Type OTHER

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.

Group P (Experimental)

Women with periodontitis and without osteoporosis (n=20)

clinical assessment

Intervention Type OTHER

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 Evaluation

Intervention Type DIAGNOSTIC_TEST

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 assessment

Intervention Type OTHER

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 assessment

Intervention Type OTHER

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 assessment

Intervention Type OTHER

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 assessment

Intervention Type OTHER

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.

Group O (Experimental)

Periodontally healthy women with osteoporosis (n = 20)

clinical assessment

Intervention Type OTHER

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 Evaluation

Intervention Type DIAGNOSTIC_TEST

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 assessment

Intervention Type OTHER

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 assessment

Intervention Type OTHER

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 assessment

Intervention Type OTHER

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 assessment

Intervention Type OTHER

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.

Group OP (Experimental)

Women with periodontitis and osteoporosis (n = 20)

clinical assessment

Intervention Type OTHER

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 Evaluation

Intervention Type DIAGNOSTIC_TEST

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 assessment

Intervention Type OTHER

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 assessment

Intervention Type OTHER

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 assessment

Intervention Type OTHER

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 assessment

Intervention Type OTHER

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.

Interventions

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clinical assessment

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.

Intervention Type OTHER

Radiographic Evaluation

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.

Intervention Type DIAGNOSTIC_TEST

clinical assessment

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.

Intervention Type OTHER

clinical assessment

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.

Intervention Type OTHER

clinical assessment

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.

Intervention Type OTHER

clinical assessment

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.

Intervention Type OTHER

Other Intervention Names

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Clinical Index and Measurements Bone Mineral Density Measurements klinik indeksler ve ölçüm klinik indeksler ve ölçüm klinik indeksler ve ölçümler klinik indeksler ve ölçümler

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

43 Years

Maximum Eligible Age

78 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Recep Tayyip Erdogan University

OTHER

Sponsor Role lead

Responsible Party

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Mujde Cilkus

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MUJDE CİLKUS, Research Assistant

Role: PRINCIPAL_INVESTIGATOR

Recep Tayyip Erdogan University

Locations

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Recep Tayyip Erdoğan University

Rize, Rize Province, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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RecepTayyipErdoganU-DHF-MC-01

Identifier Type: -

Identifier Source: org_study_id