Changes of GCF Levels of RANKL and Osteoprotegerin in Postmenopausal Osteoporosis

Sponsor

Ondokuz Mayıs University (Other)

Overall Status

Completed

CT.gov ID

NCT02808988

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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

RANKL and OPG values were measured by enzyme-linked immunosorbent assays.

Condition or Disease	Intervention/Treatment	Phase
Chronic Periodontitis	Procedure: periodontal phase 1 therapy Procedure: gingival crevicular fluid collection Other: zoledronic acid	Phase 4

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

Actual Enrollment :

47 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Screening

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group A periodontal phase 1 therapy consisted of scaling and root planning, bisphosphonate therapy (zoledronic acid), gingival crevicular fluid collection	Procedure: 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. Other: zoledronic acid 5 mg/year zoledronic acid (i.v.)
Active Comparator: group B periodontal phase 1 therapy consisted of scaling and root planning, no bisphosphonate therapy,gingival crevicular fluid collection	Procedure: 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.
Active Comparator: group C no periodontal phase 1 therapy, bisphosphonate therapy (zoledronic acid), gingival crevicular fluid collection	Procedure: gingival crevicular fluid collection gingival crevicular fluid collection by periopapers Other: zoledronic acid 5 mg/year zoledronic acid (i.v.)
Active Comparator: group D no periodontal phase 1 therapy, no bisphosphonate therapy,gingival crevicular fluid collection	Procedure: gingival crevicular fluid collection gingival crevicular fluid collection by periopapers

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 66 Years

Sexes Eligible for Study:

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.