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

NCT04531800 | Completed

• 1 other identifier: School of Dentistry
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healing Surgical Wounds; Infection

Keywords

osteonecrosis; osteoporosis; concentrated growth factor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Study Group

EXPERIMENTAL

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.

Procedure: Concentrated growth factor

Control Group

EXPERIMENTAL

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).

Procedure: Non-concentrated growth factor

Interventions

Concentrated growth factor PROCEDURE

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.

Study Group

Non-concentrated growth factor PROCEDURE

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.

Control Group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Gender Eligibility Details: Because of the large number of cases of osteoporosis and breast cancer, MRONJ was found to be more common in women.
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Related Publications (1)

• 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.

  PMID: 35866376 DERIVED

MeSH Terms

Conditions

Infections; Osteonecrosis; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gözde Işık

  Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 31, 2020
• Study Start: May 1, 2016
• Primary Completion: March 26, 2018
• Study Completion: April 2, 2018
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share