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Alterations of GCF Levels of Sclerostin and DKK-1 in Postmenopausal Osteoporosis

NCT04149405 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2021-03-11

Study results available
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Summary

Symptoms of periodontal disease are tissue destruction and destruction of the alveolar bone which supports the tooth. Wnt way (wingless-type MMTV integration site family) plays a role in the regulation of bone homeostasis in periodontal disease-induced bone resorption. The Wnt / β-catenin signal is controlled by physiological antagonists, including dickkopf released from osteocytes-associated protein 1 (DKK-1) and sclerostin (SOST). Thus, Wnt inhibitors SOST and DKK-1 affect bone mass changes. Bisphosphonates used in osteoporous treatment are selective inhibitors of bone resorption. In the serum of postmenopausal osteoporotic women treated with bisphosphonate, short-term and decreased DKK-1 level during the treatment, and increased SOST in the late period were reported. Increased bone formation after bisphosphonate treatment in postmenopausal osteoporotic patients has been associated with increased serum SOST level. The aim of our study is to investigate the effect of bisphosphonate in patients with post-menopausal osteoporosis on the bone demolition metabolism in periodontally healthy and periodontally diseased tooth regions and gingival health with the clinical data by investigating the SOST and DDK-1 molecules that play role in bone destruction mechanism.

Conditions

  • Osteoporosis, Postmenopausal
  • Periodontitis

Interventions

PROCEDURE

Phase 1 periodontal therapy

Scaling and root planning with ultrasonic and hand instruments under local anesthesia.

DRUG

Bisphosphonate therapy

Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year

Sponsors & Collaborators

  • Ondokuz Mayıs University

    lead OTHER

Principal Investigators

  • Eser Acarel, PhD,Prof.Dr. · Ondokuz Mayıs University, School of Dentistry, Department of Periodontology

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
51 Years
Max Age
66 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-12-06
Completion
2018-12-28
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04149405 on ClinicalTrials.gov