Relationship Between Periodontal Disease and Postmenopausal Osteoporosis

December 8, 2025 updated by: Mujde Cilkus, Recep Tayyip Erdogan University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Rize Province
      • Rize, Rize Province, Turkey (Türkiye), 53020
        • Recep Tayyip Erdogan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Postmenopausal female patients applying to the Periodontics Clinic of Recep Tayyip Erdoğan University Faculty of Dentistry

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group C (Control)
Periodontally and systemically healthy women without osteoporosis (n=20)
Other: 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.
Other Names:
  • Clinical Index and Measurements
Diagnostic test: 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.
Other Names:
  • Bone Mineral Density Measurements
Other: 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.
Other Names:
  • klinik indeksler ve ölçüm
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.
Other Names:
  • klinik indeksler ve ölçüm
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.

Other Names:
  • klinik indeksler ve ölçümler
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.

Other Names:
  • klinik indeksler ve ölçümler
Group P (Experimental)
Women with periodontitis and without osteoporosis (n=20)
Other: 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.
Other Names:
  • Clinical Index and Measurements
Diagnostic test: 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.
Other Names:
  • Bone Mineral Density Measurements
Other: 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.
Other Names:
  • klinik indeksler ve ölçüm
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.
Other Names:
  • klinik indeksler ve ölçüm
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.

Other Names:
  • klinik indeksler ve ölçümler
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.

Other Names:
  • klinik indeksler ve ölçümler
Group O (Experimental)
Periodontally healthy women with osteoporosis (n = 20)
Other: 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.
Other Names:
  • Clinical Index and Measurements
Diagnostic test: 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.
Other Names:
  • Bone Mineral Density Measurements
Other: 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.
Other Names:
  • klinik indeksler ve ölçüm
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.
Other Names:
  • klinik indeksler ve ölçüm
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.

Other Names:
  • klinik indeksler ve ölçümler
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.

Other Names:
  • klinik indeksler ve ölçümler
Group OP (Experimental)
Women with periodontitis and osteoporosis (n = 20)
Other: 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.
Other Names:
  • Clinical Index and Measurements
Diagnostic test: 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.
Other Names:
  • Bone Mineral Density Measurements
Other: 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.
Other Names:
  • klinik indeksler ve ölçüm
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.
Other Names:
  • klinik indeksler ve ölçüm
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.

Other Names:
  • klinik indeksler ve ölçümler
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.

Other Names:
  • klinik indeksler ve ölçümler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Sample Collection
Time Frame: 6 month
Venous blood samples will from the left antecubital fossa of the patients
6 month
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.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Recep Tayyip Erdogan University

Investigators

  • Principal Investigator: MUJDE CİLKUS, Research Assistant, Recep Tayyip Erdogan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2022

Primary Completion (Actual)

November 10, 2022

Study Completion (Actual)

May 10, 2023

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RecepTayyipErdoganU-DHF-MC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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