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Surgical Management of Medication Related Osteonecrosis of the Jaws With Concentrated Growth Factor

Primary Purpose

Healing Surgical Wounds, Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Concentrated growth factor
Non-concentrated growth factor
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healing Surgical Wounds focused on measuring osteonecrosis, osteoporosis, concentrated growth factor

Eligibility Criteria

65 Years - 85 Years (Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. treatment with oral bisphosphonates (BPs) for osteoporosis,
  2. MRONJ diagnosis with exposed bone in the jaws that had persisted for longer than 8 weeks according to 2014 recommendations of the Association of Oral and Maxillofacial Surgeons (AAOMS),
  3. MRONJ stage 2 or 3 with bone destruction and sequestrum confirmed by clinical and radiographic examination,
  4. insufficient improvement with conservative treatment.

Exclusion Criteria:

  1. a history of head and neck radiation therapy,
  2. metastatic bone disease of the jaws,
  3. platelet values under than 150,000 mm3 in a complete blood count.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Study Group

    Control Group

    Arm Description

    The necrotic bone was removed with rotating burs, curettage was performed, and the surface of the bone was smoothened. CGF was then applied to the surgical area in the study group (n=14), and the area was primarily closed after additional releasing incisions were made to the periosteum to assure tension-free soft tissue closure.

    The surgical area was only primarily closed without any mobilization of the flap following sequestrectomy and bone curettage as a traditional surgical therapy, in the control group (n=14).

    Outcomes

    Primary Outcome Measures

    Soft tissue healing
    Healing was defined as the previous studies. The patients underwent weekly clinical examinations for the 1st month and then monthly clinical examinations for 6 months postoperatively. At the time of the evaluation, soft tissue coverage in the surgical site was assessed without signs of infection and/or necrotic bone. The presence of infection was assessed as follows: erythema, swelling, bleeding on probing and purulent exudate.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 26, 2020
    Last Updated
    August 26, 2020
    Sponsor
    Ege University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04531800
    Brief Title
    Surgical Management of Medication Related Osteonecrosis of the Jaws With Concentrated Growth Factor
    Official Title
    The Effect of Concentrated Growth Factor (CGF) in Surgical Treatment of Medication-related Osteonecrosis of the Jaw (MRONJ) in Osteoporosis Patients: a Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2016 (Actual)
    Primary Completion Date
    March 26, 2018 (Actual)
    Study Completion Date
    April 2, 2018 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this present study was to evaluate the efficiency of the growth factors delivered by concentrated growth factor (CGF) on the healing process of osteoporotic patients with medication-related osteonecrosis of the jaws (MRONJ). This randomized controlled study composed of osteoporotic female patients who were treated with oral bisphosphonates (BPs) and diagnosed with MRONJ. For the CGF group, each patient was treated with local application of CGF at the surgical site after removing the necrotic bone while the surgical area was only primarily closed as traditional surgical therapy for the control group. The patients underwent clinical examinations for 6 months postoperatively to check the presence of infection and dehiscence.
    Detailed Description
    This randomized controlled study comprised 28 elderly female osteoporotic patients diagnosed with MRONJ at the department of oral and maxillofacial surgery of a university hospital between May 2016 and April 2018. Before the surgery, the sequentially numbered sealed envelopes were used to randomly assign patients to the study groups: Study group (14 patients treated with CGF clots + primarily closure) Control group (14 patients treated without CGF placement + primarily closure) All procedures were performed under local anesthesia by the same surgeon. After removal of superficial bone sequestrum, the necrotic bone was removed with rotating burs, curettage was performed, and the surface of the bone was smoothened (Fig. 2). CGF was then applied to the surgical area in the study group (n=14), and the area was primarily closed after additional releasing incisions were made to the periosteum to assure tension-free soft tissue closure (Fig. 3). In the control group (n=14), the surgical area was only primarily closed without any mobilization of the flap following sequestrectomy and bone curettage as a traditional surgical therapy. A soft diet and daily irrigation with 0.12% chlorhexidine were prescribed for 2 weeks postoperatively. The sutures were removed 14 days postoperatively. The primary outcome variable of this study was soft tissue healing 6 months post-operatively. The patients underwent weekly clinical examinations for the 1st month and then monthly clinical examinations for 6 months postoperatively. At the time of the evaluation, soft tissue coverage in the surgical site was assessed without signs of infection and/or necrotic bone. The presence of infection was assessed as follows: erythema, swelling, bleeding on probing and purulent exudate. The differences between the study groups were recorded and considered to indicate postoperative healing. BP treatment status and ONJ classification of each patient were recorded and these differences were also assessed in soft tissue healing. In addition, anamnestic and therapeutic data as patients' age, the type of BPs, timing of medication, location of the exposed necrotic bone and MRONJ-promoting factors were recorded for each patient.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healing Surgical Wounds, Infection
    Keywords
    osteonecrosis, osteoporosis, concentrated growth factor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study Group
    Arm Type
    Experimental
    Arm Description
    The necrotic bone was removed with rotating burs, curettage was performed, and the surface of the bone was smoothened. CGF was then applied to the surgical area in the study group (n=14), and the area was primarily closed after additional releasing incisions were made to the periosteum to assure tension-free soft tissue closure.
    Arm Title
    Control Group
    Arm Type
    Experimental
    Arm Description
    The surgical area was only primarily closed without any mobilization of the flap following sequestrectomy and bone curettage as a traditional surgical therapy, in the control group (n=14).
    Intervention Type
    Procedure
    Intervention Name(s)
    Concentrated growth factor
    Intervention Description
    In the concentrated growth factor (CGF) group, CGF was applied to the surgical area (n=14), and the area was primarily closed after additional releasing incisions.
    Intervention Type
    Procedure
    Intervention Name(s)
    Non-concentrated growth factor
    Intervention Description
    In the non-CGF group, the surgical area was only primarily closed without any mobilization of the flap following sequestrectomy and bone curettage as a traditional surgical therapy.
    Primary Outcome Measure Information:
    Title
    Soft tissue healing
    Description
    Healing was defined as the previous studies. The patients underwent weekly clinical examinations for the 1st month and then monthly clinical examinations for 6 months postoperatively. At the time of the evaluation, soft tissue coverage in the surgical site was assessed without signs of infection and/or necrotic bone. The presence of infection was assessed as follows: erythema, swelling, bleeding on probing and purulent exudate.
    Time Frame
    Change of soft tissue healing 6 months postoperatively

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Because of the large number of cases of osteoporosis and breast cancer, MRONJ was found to be more common in women.
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: treatment with oral bisphosphonates (BPs) for osteoporosis, MRONJ diagnosis with exposed bone in the jaws that had persisted for longer than 8 weeks according to 2014 recommendations of the Association of Oral and Maxillofacial Surgeons (AAOMS), MRONJ stage 2 or 3 with bone destruction and sequestrum confirmed by clinical and radiographic examination, insufficient improvement with conservative treatment. Exclusion Criteria: a history of head and neck radiation therapy, metastatic bone disease of the jaws, platelet values under than 150,000 mm3 in a complete blood count.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gözde Işık
    Organizational Affiliation
    Lecturer
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35866376
    Citation
    Beth-Tasdogan NH, Mayer B, Hussein H, Zolk O, Peter JU. Interventions for managing medication-related osteonecrosis of the jaw. Cochrane Database Syst Rev. 2022 Jul 12;7(7):CD012432. doi: 10.1002/14651858.CD012432.pub3.
    Results Reference
    derived

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    Surgical Management of Medication Related Osteonecrosis of the Jaws With Concentrated Growth Factor

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