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

NCT04531800 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-08-31

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Concentrated growth factor

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.

PROCEDURE

Non-concentrated growth factor

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.

Sponsors & Collaborators

  • Ege University

    lead OTHER

Principal Investigators

  • Gözde Işık · Lecturer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-01
Primary Completion
2018-03-26
Completion
2018-04-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04531800 on ClinicalTrials.gov