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Changes of GCF Levels of RANKL and Osteoprotegerin in Postmenopausal Osteoporosis

O

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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