Changes of GCF Levels of RANKL and Osteoprotegerin in Postmenopausal Osteoporosis

Study Overview
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Brief Summary
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The investigators evaluated the effect of initial periodontal treatment on clinical findings and receptor activator of Nuclear Factor-kappa B ligand (RANKL) and osteoprotegerin (OPG) in gingival crevicular fluid (GCF) of patients with osteoporosis under bisphosphonate therapy within 12 months' follow-up. Clinical recordings and GCF were obtained from postmenopausal women; with chronic periodontitis and osteoporosis (Group A, n=13), with chronic periodontitis and no osteoporosis (Group B, n=12), without chronic periodontitis and osteoporosis (Group C, n=12), systemically and periodontally healthy controls (Group D, n=10) at the baseline. Recordings were repeated at the 1st, 6th and 12th months in Group A, B and C. RANKL and OPG values were measured by enzyme-linked immunosorbent assays.

Detailed Description
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The study groups were selected from postmenopausal patients those referred to Department of Endocrinology, School of Medicine, Ondokuz Mayis University. Bone mineral density (BMD) measurements were performed by dual energy-X-ray absorptiometry from L1-L4 site of lumbar vertebra and/or femur (g/cm2). Osteoporosis was defined as T scores less than -2.5 at L1-L4, femur neck or total femur. Women with T scores less than -2.5 (groups A and C) were started on bisphosphonate treatment after their initial periodontal examination.

Official Title
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Effect of Periodontal Therapy and Bisphosphonates on Gingival Crevicular Fluid Levels of Nuclear Factor- κb Ligand (RANKL) and Osteoprotegerin in Postmenopausal Osteoporosis: Results of a 12-Month Study

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Procedure: periodontal phase 1 therapy
* Procedure: gingival crevicular fluid collection
* Other: zoledronic acid


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 within the last 6 months.

Ages Eligible for Study
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Minimum Age: 50 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: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br>periodontal phase 1 therapy consisted of scaling and root planning, bisphosphonate therapy (zoledronic acid), gingival crevicular fluid collection | Procedure: periodontal phase 1 therapy<br>* periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia and gingival crevicular fluid collection by the same investigator.<br>Other: zoledronic acid<br>* 5 mg/year zoledronic acid (i.v.)<br>|
| Active Comparator: group B<br>periodontal phase 1 therapy consisted of scaling and root planning, no bisphosphonate therapy,gingival crevicular fluid collection | Procedure: periodontal phase 1 therapy<br>* periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia and gingival crevicular fluid collection by the same investigator.<br>|
| Active Comparator: group C<br>no periodontal phase 1 therapy, bisphosphonate therapy (zoledronic acid), gingival crevicular fluid collection | Procedure: gingival crevicular fluid collection<br>* gingival crevicular fluid collection by periopapers<br>Other: zoledronic acid<br>* 5 mg/year zoledronic acid (i.v.)<br>|
| Active Comparator: group D<br>no periodontal phase 1 therapy, no bisphosphonate therapy,gingival crevicular fluid collection | Procedure: gingival crevicular fluid collection<br>* gingival crevicular fluid collection by periopapers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival crevicular fluid levels of osteoprotegerin (OPG) and receptor activator of Nuclear Factor-kappa B ligand (RANKL) | molecules having roles in bone resorption | Changes from Baseline osteoprotegerin (OPG) and receptor activator of Nuclear Factor-kappa B ligand (RANKL) at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RANKL, Bisphosphonate, osteoporosis, OPG, periodontitis