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Changes of GCF Levels of RANKL and Osteoprotegerin in Postmenopausal Osteoporosis

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
periodontal phase 1 therapy
gingival crevicular fluid collection
zoledronic acid
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Chronic Periodontitis focused on measuring Bisphosphonate, osteoporosis, RANKL, OPG, periodontitis

Eligibility Criteria

50 Years - 66 Years (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    group A

    group B

    group C

    group D

    Arm Description

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

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

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

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

    Outcomes

    Primary Outcome Measures

    Gingival crevicular fluid levels of osteoprotegerin (OPG) and receptor activator of Nuclear Factor-kappa B ligand (RANKL)
    molecules having roles in bone resorption

    Secondary Outcome Measures

    Full Information

    First Posted
    May 27, 2016
    Last Updated
    June 19, 2016
    Sponsor
    Ondokuz Mayıs University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02808988
    Brief Title
    Changes of GCF Levels of RANKL and Osteoprotegerin in Postmenopausal Osteoporosis
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ondokuz Mayıs University

    4. Oversight

    Data Monitoring Committee
    No

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis
    Keywords
    Bisphosphonate, osteoporosis, RANKL, OPG, periodontitis

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    group A
    Arm Type
    Active Comparator
    Arm Description
    periodontal phase 1 therapy consisted of scaling and root planning, bisphosphonate therapy (zoledronic acid), gingival crevicular fluid collection
    Arm Title
    group B
    Arm Type
    Active Comparator
    Arm Description
    periodontal phase 1 therapy consisted of scaling and root planning, no bisphosphonate therapy,gingival crevicular fluid collection
    Arm Title
    group C
    Arm Type
    Active Comparator
    Arm Description
    no periodontal phase 1 therapy, bisphosphonate therapy (zoledronic acid), gingival crevicular fluid collection
    Arm Title
    group D
    Arm Type
    Active Comparator
    Arm Description
    no periodontal phase 1 therapy, no bisphosphonate therapy,gingival crevicular fluid collection
    Intervention Type
    Procedure
    Intervention Name(s)
    periodontal phase 1 therapy
    Intervention Description
    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
    Intervention Name(s)
    gingival crevicular fluid collection
    Intervention Description
    gingival crevicular fluid collection by periopapers
    Intervention Type
    Other
    Intervention Name(s)
    zoledronic acid
    Intervention Description
    5 mg/year zoledronic acid (i.v.)
    Primary Outcome Measure Information:
    Title
    Gingival crevicular fluid levels of osteoprotegerin (OPG) and receptor activator of Nuclear Factor-kappa B ligand (RANKL)
    Description
    molecules having roles in bone resorption
    Time Frame
    Changes from Baseline osteoprotegerin (OPG) and receptor activator of Nuclear Factor-kappa B ligand (RANKL) at 12 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    66 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eser Sakallıoğlu, PhD,Prof.Dr.
    Organizational Affiliation
    Ondokuz Mayıs University, School of Dentistry, Department of Periodontology, Samsun, Turkey
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    18275008
    Citation
    Anastasilakis AD, Goulis DG, Polyzos SA, Gerou S, Koukoulis G, Kita M, Avramidis A. Serum osteoprotegerin and RANKL are not specifically altered in women with postmenopausal osteoporosis treated with teriparatide or risedronate: a randomized, controlled trial. Horm Metab Res. 2008 Apr;40(4):281-5. doi: 10.1055/s-2008-1046787. Epub 2008 Feb 15.
    Results Reference
    background
    PubMed Identifier
    16018754
    Citation
    Lane N, Armitage GC, Loomer P, Hsieh S, Majumdar S, Wang HY, Jeffcoat M, Munoz T. Bisphosphonate therapy improves the outcome of conventional periodontal treatment: results of a 12-month, randomized, placebo-controlled study. J Periodontol. 2005 Jul;76(7):1113-22. doi: 10.1902/jop.2005.76.7.1113.
    Results Reference
    result
    PubMed Identifier
    14742657
    Citation
    Mogi M, Otogoto J, Ota N, Togari A. Differential expression of RANKL and osteoprotegerin in gingival crevicular fluid of patients with periodontitis. J Dent Res. 2004 Feb;83(2):166-9. doi: 10.1177/154405910408300216.
    Results Reference
    result
    PubMed Identifier
    17355365
    Citation
    Bostanci N, Ilgenli T, Emingil G, Afacan B, Han B, Toz H, Atilla G, Hughes FJ, Belibasakis GN. Gingival crevicular fluid levels of RANKL and OPG in periodontal diseases: implications of their relative ratio. J Clin Periodontol. 2007 May;34(5):370-6. doi: 10.1111/j.1600-051X.2007.01061.x. Epub 2007 Mar 13.
    Results Reference
    result
    PubMed Identifier
    22326720
    Citation
    Babur C, Ozcan G, Cebi DU, Pervane B, Ozdemir B, Yucel A, Biri AA, Babur C. Gingival crevicular fluid levels of osteoprotegerin (OPG) in premenopausal and postmenopausal women with or without chronic periodontitis. J Dent. 2012 May;40(5):364-71. doi: 10.1016/j.jdent.2012.01.013. Epub 2012 Feb 2.
    Results Reference
    result
    PubMed Identifier
    23327689
    Citation
    Gumus P, Buduneli E, Biyikoglu B, Aksu K, Sarac F, Nile C, Lappin D, Buduneli N. Gingival crevicular fluid, serum levels of receptor activator of nuclear factor-kappaB ligand, osteoprotegerin, and interleukin-17 in patients with rheumatoid arthritis and osteoporosis and with periodontal disease. J Periodontol. 2013 Nov;84(11):1627-37. doi: 10.1902/jop.2013.120595. Epub 2013 Jan 17.
    Results Reference
    result
    PubMed Identifier
    21261673
    Citation
    Bostanci N, Saygan B, Emingil G, Atilla G, Belibasakis GN. Effect of periodontal treatment on receptor activator of NF-kappaB ligand and osteoprotegerin levels and relative ratio in gingival crevicular fluid. J Clin Periodontol. 2011 May;38(5):428-33. doi: 10.1111/j.1600-051X.2011.01701.x. Epub 2011 Jan 24.
    Results Reference
    result

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    Changes of GCF Levels of RANKL and Osteoprotegerin in Postmenopausal Osteoporosis

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