CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 43 enrolled
Drug / intervention
Bisphosphonate therapy +1 moredrug
Likely dose
Bisphosphonate therapy 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04149405
NCT04149405Phase 4Completed

Investigation of the Effects of Bisphosphonate on the Gingival Crevicular Fluid Levels of Sclerostin and the DKK-1 in Individuals With Postmenopausal Osteoporosis With Periodontal Changes

Ondokuz Mayıs University·interventional·Posted Nov 4, 2019·Updated Mar 11, 2021

In Brief

A Phase 4 clinical trial evaluating Phase 1 periodontal therapy and Bisphosphonate therapy for Osteoporosis, Postmenopausal and Periodontitis. Completed, enrolled 43 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 4, 2019
Enrollment StartJun 30, 2016
Primary CompletionDec 6, 2017
Study CompletionDec 28, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.7 years ago

Interventions

Phase 1 periodontal therapyprocedure

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

Bisphosphonate therapydrug

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