Changes of GCF Levels of RANKL and Osteoprotegerin in Postmenopausal Osteoporosis

Ondokuz Mayıs University

Status and phase: Completed; Phase 4

Conditions: Chronic Periodontitis

Treatments: Other: zoledronic acid; Procedure: periodontal phase 1 therapy; Procedure: gingival crevicular fluid collection

Study type: Interventional

Funder types: Other

Identifiers

NCT02808988

OMÜ KAEK 2012/138

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: Female

Ages: 50 to 66 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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47 participants in 4 patient groups

group A

Active Comparator group

Description:

periodontal phase 1 therapy consisted of scaling and root planning, bisphosphonate therapy (zoledronic acid), gingival crevicular fluid collection

Treatment:

Other: zoledronic acid

Procedure: periodontal phase 1 therapy

group B

Active Comparator group

Description:

periodontal phase 1 therapy consisted of scaling and root planning, no bisphosphonate therapy,gingival crevicular fluid collection

Treatment:

Procedure: periodontal phase 1 therapy

group C

Active Comparator group

Description:

no periodontal phase 1 therapy, bisphosphonate therapy (zoledronic acid), gingival crevicular fluid collection

Treatment:

Other: zoledronic acid

Procedure: gingival crevicular fluid collection

group D

Active Comparator group

Description:

no periodontal phase 1 therapy, no bisphosphonate therapy,gingival crevicular fluid collection

Treatment:

Procedure: gingival crevicular fluid collection