Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04149405
Recruitment Status : Completed
First Posted : November 4, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Feyza Otan ÖZDEN, Ondokuz Mayıs University

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.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Periodontitis Procedure: periodontal phase 1 therapy Drug: bisphosphonate therapy Procedure: GCF Phase 4

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, n=12), with chronic periodontitis and otherwise healthy (Group B, n=10), without chronic periodontitis and those using bisphosphonate (Group C, n=11), systemically and periodontally healthy controls (Group D, n=10) 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
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
Actual Study Start Date : June 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Active Comparator: Group A
scaling and root planning, bisphosphonate therapy (zoledronic acid)
Procedure: periodontal phase 1 therapy
periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia.

Drug: bisphosphonate therapy
bisphosphonate therapy refers to the use of zoledronic acid 5 mg/year (i.v.)

Procedure: GCF
gingival crevicular fluid collection by the same investigator.

Active Comparator: Group B
scaling and root planning, no bisphosphonate therapy
Procedure: periodontal phase 1 therapy
periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia.

Procedure: GCF
gingival crevicular fluid collection by the same investigator.

Active Comparator: Group C
scaling and root planning and bisphosphonate therapy (zoledronic acid)
Drug: bisphosphonate therapy
bisphosphonate therapy refers to the use of zoledronic acid 5 mg/year (i.v.)

Procedure: GCF
gingival crevicular fluid collection by the same investigator.

Active Comparator: Group D
no scaling and root planning no bisphosphonate therapy
Procedure: GCF
gingival crevicular fluid collection by the same investigator.




Primary Outcome Measures :
  1. levels of sclerostin (SOST) and dickkopf-related protein-1 (DKK-1) in gingival crevicular fluid [ Time Frame: 12 months ]
    changes in sclerostin (SOST) and dickkopf-related protein-1 (DKK-1) in gingival crevicular fluid from baseline to 12 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   51 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women with T scores less than -2.5 (groups A and C)
  • The periodontitis patients were selected based on the radiographical evidence of bone loss, presence of four or more sites with bleeding on probing (BOP), ≥5 mm pocket depth (PD) and ≥6 mm clinical attachment loss (CAL).
  • The clinically healthy control groups were selected on the basis of no radiographic bone loss or CAL and PD≤3 mm.

Exclusion Criteria:

  • Any known systemic disease rather than osteoporosis
  • Smoking
  • Antibiotic therapy within the last 3 months
  • Periodontal treatment in the last 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149405


Sponsors and Collaborators
Ondokuz Mayıs University
Investigators
Layout table for investigator information
Study Director: Eser Acarel, PhD,Prof.Dr. Ondokuz Mayıs University, School of Dentistry, Department of Periodontology
  Study Documents (Full-Text)

Documents provided by Feyza Otan ÖZDEN, Ondokuz Mayıs University:
Informed Consent Form  [PDF] June 1, 2017

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Feyza Otan ÖZDEN, Principal Investigator, Ondokuz Mayıs University
ClinicalTrials.gov Identifier: NCT04149405    
Other Study ID Numbers: KAEK 2016/100
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Feyza Otan ÖZDEN, Ondokuz Mayıs University:
sclerostin
dickkopf-related protein-1
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Osteoporosis, Postmenopausal
Periodontitis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs