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

Phase 4

Completed

Interventions: Procedure: Phase 1 periodontal therapy
Drug: Bisphosphonate therapy

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group A	Phase 1 periodontal therapy	* 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 A	Bisphosphonate therapy	* 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 B	Phase 1 periodontal therapy	* Subjects with chronic periodontitis and systemically healthy. * Phase 1 periodontal theraphy was administered to the subjects.
Group C	Bisphosphonate therapy	* 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.

Primary Outcome Measures

Name	Time	Method
Dkk-1 Values for 6th Month	6 months	levels of dickkopf-related protein-1 in 6th month
Sost Values for 6th Month	6 months	levels of sclerostin in 6th month

Secondary Outcome Measures

Name	Time	Method
Sost Values for 12th Month	12 month	levels of sclerostin in 12th month
Dkk-1 Values for 12th Month	12 months	levels of dickkopf-related protein-1 in 12th month