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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 47
- Primary Endpoint
- Gingival crevicular fluid levels of osteoprotegerin (OPG) and receptor activator of Nuclear Factor-kappa B ligand (RANKL)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 50 Years to 66 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •Antibiotic therapy within the last 3 months
- •Periodontal treatment within the last 6 months.
Outcomes
Primary Outcomes
Gingival crevicular fluid levels of osteoprotegerin (OPG) and receptor activator of Nuclear Factor-kappa B ligand (RANKL)
Time Frame: Changes from Baseline osteoprotegerin (OPG) and receptor activator of Nuclear Factor-kappa B ligand (RANKL) at 12 months
molecules having roles in bone resorption
Secondary Outcomes
No secondary outcomes reported
Investigators
Feyza Otan ÖZDEN
PhD
Ondokuz Mayıs University