CompletedNot Applicable

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

28 participantsStarted 2016-05-01

Plain-language 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.

Who can participate

Age range

65 Years – 85 Years

Sex

FEMALE

See this in plain English?

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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,

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Soft tissue healing

Timeframe: Change of soft tissue healing 6 months postoperatively

Trial details

NCT IDNCT04531800

SponsorEge University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03-26

View on ClinicalTrials.gov More Healing Surgical Wounds trials