Relationship Between Periodontal Disease and Postmenopausal Osteoporosis

NCT07294105 | Completed

• 1 other identifier: RecepTayyipErdoganU-DHF-MC-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. Moreover, sclerostin is considered a potential biomarker for elucidating the shared pathophysiological mechanisms linking postmenopausal osteoporosis and periodontitis

Conditions

Periodontal Disease; Postmenopausal Osteoporosis (PMO)

Keywords

Periodontitis; Postmenopausal osteoporosis; Sclerostin; Tumor necrosis factor

Outcome Measures

Primary Outcomes (2)

• Serum Sample Collection

  Venous blood samples will from the left antecubital fossa of the patients

  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.

  6 month

Study Arms (4)

Group C (Control)

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

Other: clinical assessment; Diagnostic Test: Radiographic Evaluation

Group P (Experimental)

Women with periodontitis and without osteoporosis (n=20)

Other: clinical assessment; Diagnostic Test: Radiographic Evaluation

Group O (Experimental)

Periodontally healthy women with osteoporosis (n = 20)

Other: clinical assessment; Diagnostic Test: Radiographic Evaluation

Group OP (Experimental)

Women with periodontitis and osteoporosis (n = 20)

Other: clinical assessment; Diagnostic Test: Radiographic Evaluation

Interventions

Radiographic Evaluation 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.

Also known as: Bone Mineral Density Measurements

Group C (Control); Group O (Experimental); Group OP (Experimental); Group P (Experimental)

clinical assessment 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.

Also known as: Clinical Index and Measurements

Group C (Control); Group O (Experimental); Group OP (Experimental); Group P (Experimental)

Eligibility Criteria

• Age: 43 Years - 78 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdoğan University

Rize, Rize Province, 53020, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid (GCF) samples will be collected and stored at -80°C.

MeSH Terms

Conditions

Periodontal Diseases; Osteoporosis, Postmenopausal; Periodontitis; Sclerosteosis

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• MUJDE CİLKUS, Research Assistant

  Recep Tayyip Erdogan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: November 7, 2022
• Primary Completion: November 10, 2022
• Study Completion: May 10, 2023
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)