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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-12-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Osteoporosis, Postmenopausal Periodontitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Phase 1 periodontal therapy

Intervention Type PROCEDURE

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

Bisphosphonate therapy

Intervention Type DRUG

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

Group B

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

Group Type ACTIVE_COMPARATOR

Phase 1 periodontal therapy

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Bisphosphonate therapy

Intervention Type DRUG

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

Group D

* Systemically and periodontally healthy controls
* No intervention has been made.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Phase 1 periodontal therapy

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

Intervention Type PROCEDURE

Bisphosphonate therapy

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

Intervention Type DRUG

Other Intervention Names

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Periodontal treatment Osteoporosis treatment

Eligibility Criteria

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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

Minimum Eligible Age

51 Years

Maximum Eligible Age

66 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes