Changes of GCF Levels of RANKL and Osteoprotegerin in Postmenopausal Osteoporosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-11-30

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.

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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.

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators

Study Groups

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group A

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

Group Type ACTIVE_COMPARATOR

periodontal phase 1 therapy

Intervention Type PROCEDURE

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.

zoledronic acid

Intervention Type OTHER

5 mg/year zoledronic acid (i.v.)

group B

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

Group Type ACTIVE_COMPARATOR

periodontal phase 1 therapy

Intervention Type PROCEDURE

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.

group C

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

Group Type ACTIVE_COMPARATOR

gingival crevicular fluid collection

Intervention Type PROCEDURE

gingival crevicular fluid collection by periopapers

zoledronic acid

Intervention Type OTHER

5 mg/year zoledronic acid (i.v.)

group D

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

Group Type ACTIVE_COMPARATOR

gingival crevicular fluid collection

Intervention Type PROCEDURE

gingival crevicular fluid collection by periopapers

Interventions

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periodontal phase 1 therapy

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.

Intervention Type PROCEDURE

gingival crevicular fluid collection

gingival crevicular fluid collection by periopapers

Intervention Type PROCEDURE

zoledronic acid

5 mg/year zoledronic acid (i.v.)

Intervention Type OTHER

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

66 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes