Infection Clinical Trial
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
Verified date | August 2020 |
Source | Ege University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | April 2, 2018 |
Est. primary completion date | March 26, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 65 Years to 85 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ege University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Change of soft tissue healing 6 months postoperatively |
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