Surgical Management of Medication Related Osteonecrosis of the Jaws With Concentrated Growth Factor
Condition: Healing Surgical Wounds; Infection
MeSH terms: Osteonecrosis; Surgical Wound
Study type: Interventional

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.
    

Intervention name(s): Concentrated growth factor; Non-concentrated growth factor
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: osteonecrosis; osteoporosis; concentrated growth factor