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Completed

NCT Number: NCT04149405

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

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.

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Key information

Conditions

Osteoporosis, Postmenopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Mouth Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Periodontal Diseases Periodontitis Sclerosteosis Stomatognathic Diseases

Age range

51 year–66 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phase 1 periodontal therapy

Procedure

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

Other names: Periodontal treatment

Bisphosphonate therapy

Drug

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

Other names: Osteoporosis treatment

Primary outcomes

  1. Sost Values for 6th Month

    Time frame: 6 months

    levels of sclerostin in 6th month

  2. Dkk-1 Values for 6th Month

    Time frame: 6 months

    levels of dickkopf-related protein-1 in 6th month

Secondary outcomes

  1. Sost Values for 12th Month

    Time frame: 12 month

    levels of sclerostin in 12th month

  2. Dkk-1 Values for 12th Month

    Time frame: 12 months

    levels of dickkopf-related protein-1 in 12th month

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Nov 4, 2019
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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