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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Osteoporosis, Postmenopausal, Periodontitis

Intervention / Treatment
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* Procedure: Phase 1 periodontal therapy
* Drug: Bisphosphonate therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 51 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sost Values for 6th Month | levels of sclerostin in 6th month | 6 months | 
| Dkk-1 Values for 6th Month | 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 | levels of sclerostin in 12th month | 12 month | 
| Dkk-1 Values for 12th Month | levels of dickkopf-related protein-1 in 12th month | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sclerostin, dickkopf-related protein-1