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临床试验/NCT04149405
NCT04149405已完成4 期

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 University0 个研究点目标入组 43 人开始时间: 2016年6月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
43
主要终点
Dkk-1 Values for 6th Month

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
51 Years 至 66 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Group A

Active Comparator
  • 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.

干预措施: Phase 1 periodontal therapy (Procedure)

Group A

Active Comparator
  • 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.

干预措施: Bisphosphonate therapy (Drug)

Group B

Active Comparator
  • Subjects with chronic periodontitis and systemically healthy.
  • Phase 1 periodontal theraphy was administered to the subjects.

干预措施: Phase 1 periodontal therapy (Procedure)

Group C

Active Comparator
  • 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.

干预措施: Bisphosphonate therapy (Drug)

结局指标

主要结局

Dkk-1 Values for 6th Month

时间窗: 6 months

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

Sost Values for 6th Month

时间窗: 6 months

levels of sclerostin in 6th month

次要结局

  • Sost Values for 12th Month(12 month)
  • Dkk-1 Values for 12th Month(12 months)

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Feyza Otan ÖZDEN

Principal Investigator

Ondokuz Mayıs University

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