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

February 18, 2021 updated by: Feyza Otan ÖZDEN, Ondokuz Mayıs University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
  • Subjects with chronic periodontitis and osteoporosis.
  • Phase 1 periodontal therapy and bisphosphonate therapy ( Aclasta: intravenous infusion of 5 mg of zoledronic acid once a year) were administered to the subjects.
Procedure: Phase 1 periodontal therapy
Scaling and root planning with ultrasonic and hand instruments under local anesthesia.
Other Names:
  • Periodontal treatment
Drug: Bisphosphonate therapy
Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year
Other Names:
  • Osteoporosis treatment
Active Comparator: Group B
  • Subjects with chronic periodontitis and systemically healthy.
  • Phase 1 periodontal theraphy was administered to the subjects.
Procedure: Phase 1 periodontal therapy
Scaling and root planning with ultrasonic and hand instruments under local anesthesia.
Other Names:
  • Periodontal treatment
Active Comparator: Group C
  • Subjects with periodontally healthy and osteoporosis.
  • Bisphosphonate therapy ( Aclasta: intravenous infusion of 5 mg of zoledronic acid once a year) were administered to the subjects.
Drug: Bisphosphonate therapy
Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year
Other Names:
  • Osteoporosis treatment
No Intervention: Group D
  • Systemically and periodontally healthy controls
  • No intervention has been made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sost Values for 6th Month
Time Frame: 6 months
levels of sclerostin in 6th month
6 months
Dkk-1 Values for 6th Month
Time Frame: 6 months
levels of dickkopf-related protein-1 in 6th month
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sost Values for 12th Month
Time Frame: 12 month
levels of sclerostin in 12th month
12 month
Dkk-1 Values for 12th Month
Time Frame: 12 months
levels of dickkopf-related protein-1 in 12th month
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2016

Primary Completion (Actual)

December 6, 2017

Study Completion (Actual)

December 28, 2018

Study Registration Dates

First Submitted

October 12, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (Actual)

November 4, 2019

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK 2016/100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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