Changes of GCF Levels of RANKL and Osteoprotegerin in Postmenopausal Osteoporosis

Phase 4

Completed

• Conditions: Chronic Periodontitis
• Interventions: Procedure: periodontal phase 1 therapy; Procedure: gingival crevicular fluid collection; Other: zoledronic acid

• Registration Number: NCT02808988
• Lead Sponsor: Ondokuz Mayıs University

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Study First Submitted: 2016-05-27
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-19
• Last Update Submitted: 2016-06-19
• Study First Posted: 2016-06-22
• Last Update Posted: 2016-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	periodontal phase 1 therapy	periodontal phase 1 therapy consisted of scaling and root planning, bisphosphonate therapy (zoledronic acid), gingival crevicular fluid collection
group C	zoledronic acid	no periodontal phase 1 therapy, bisphosphonate therapy (zoledronic acid), gingival crevicular fluid collection
group A	zoledronic acid	periodontal phase 1 therapy consisted of scaling and root planning, bisphosphonate therapy (zoledronic acid), gingival crevicular fluid collection
group B	periodontal phase 1 therapy	periodontal phase 1 therapy consisted of scaling and root planning, no bisphosphonate therapy,gingival crevicular fluid collection
group C	gingival crevicular fluid collection	no periodontal phase 1 therapy, bisphosphonate therapy (zoledronic acid), gingival crevicular fluid collection
group D	gingival crevicular fluid collection	no periodontal phase 1 therapy, no bisphosphonate therapy,gingival crevicular fluid collection

Primary Outcome Measures

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