Viewing Study NCT04149405



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Last Modification Date: 2024-10-26 @ 1:21 PM
Study NCT ID: NCT04149405
Status: COMPLETED
Last Update Posted: 2021-03-11
First Post: 2019-10-12

Brief Title: Alterations of GCF Levels of Sclerostin and DKK-1 in Postmenopausal Osteoporosis
Sponsor: Ondokuz Mayıs University
Organization: Ondokuz Mayıs University

Study Overview

Official Title: 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
Status: COMPLETED
Status Verified Date: 2020-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: This study aims to reveal the effect of initial periodontal treatment together with bisphosphonate on sclerostin SOST and dickkopf-related protein-1 DKK-1 in gingival crevicular fluid GCF of patients with osteoporosis

Clinical recordings and GCF were obtained from postmenopausal women with chronic periodontitis and those using bisphosphonate Group A n12 with chronic periodontitis and otherwise healthy Group B n10 without chronic periodontitis and those using bisphosphonate Group C n11 systemically and periodontally healthy controls Group D n10 at the baseline

GCF sampling were recorded and repeated at the 6th and 12th months in Group A B and C SOST and DKK-1 values were measured by ELISA

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None