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Changes of GCF Levels of RANKL and Osteoprotegerin in Postmenopausal Osteoporosis

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ClinicalTrials.gov Identifier: NCT02808988
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : June 22, 2016
Sponsor:
Information provided by (Responsible Party):
Feyza Otan ÖZDEN, Ondokuz Mayıs University

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.

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   50 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808988


Sponsors and Collaborators
Ondokuz Mayıs University
Investigators
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Study Director: Eser Sakallıoğlu, PhD,Prof.Dr. Ondokuz Mayıs University, School of Dentistry, Department of Periodontology, Samsun, Turkey

Publications of Results:

Other Publications:
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Responsible Party: Feyza Otan ÖZDEN, PhD, Ondokuz Mayıs University
ClinicalTrials.gov Identifier: NCT02808988     History of Changes
Other Study ID Numbers: OMÜ KAEK 2012/138
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Feyza Otan ÖZDEN, Ondokuz Mayıs University:
Bisphosphonate
osteoporosis
RANKL
OPG
periodontitis
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Periodontitis
Chronic Periodontitis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Zoledronic Acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs