Piezoeletric Surgery vs Conventional Surgery for Treatment of MRONJ

Condition(s) studied

Investigational drug(s) / intervention(s)

Piezoelectric surgery: Patients enrolled and randomized into one of the two groups will all undergo surgery to remove necrotic bone on an outpatient basis by the same operator with a decade of experience in the treatment of MRONJ. As per clinical routine, a marginal bone resection procedure will be performed using rotary instruments or piezoelectric instruments (depending on the assignment to one of the two groups). Both surgical procedures involve complete closure of the wound by primary intention using sutures

Conventional surgery: Patients enrolled and randomized into one of the two groups will all undergo surgery to remove necrotic bone on an outpatient basis by the same operator with a decade of experience in the treatment of MRONJ. As per clinical routine, a marginal bone resection procedure will be performed using rotary instruments or piezoelectric instruments (depending on the assignment to one of the two groups). Both surgical procedures involve complete closure of the wound by primary intention using sutures

Study summary

To date, surgical therapy of MRONJ remains the therapy of choice while still in association with a medical approach. Surgical intervention aims to stop the progression of the pathology through the removal of the tissue macroscopically affected (resective surgery,sequestrectomy, debridement).

These surgical procedures are classically performed by the use of handpiece burs, but due to the advent of piezoelectric surgery in dentistry, a comparison of the two techniques is required

At present there are no randomized clinical trials designed to compare the postoperative discomfort of the two previously described techniques in the treatment of MRONJ. Therefore, the aim of this study is to evaluate the postoperative discomfort in a group of patients undergoing surgical therapy for MRONJ with piezoelectric instruments compared to a control group undergoing MRONJ surgical therapy with traditional rotary instruments.

METHODS This is a randomized clinical trial conducted in patients diagnosed with MRONJ who require surgical therapy.

Patients will be recruited and evaluated for a period of 24 months. Follow-up of patients enrolled in the study will last 12 months. Specifically, once patients diagnosed with MRONJ requiring surgical therapy are identified, surgery will be scheduled within 1 month, then follow-up visits will be conducted at 1, 2, 3 weeks and 3, 6, 12 months after surgery.

Patients enrolled and randomized into one of the two groups will all undergo necrotic bone removal surgery by the same operator with decades of experience in treating MRONJs. Marginal bone resection surgery will be performed using rotary or piezoelectric instruments. Both surgical procedures involve wound closure by first intention healing using sutures. Each bone block removed will undergo histologic examination for diagnostic confirmation of osteonecrosis. Postoperative instructions will be explained to patients, and sutures will be removed at 7 or 14 days after surgery.

Each patient will be asked for a 3D radiologic exam (CT or CBCT) at least 12 months after surgery in order to asses the

Eligibility

Primary outcome measure(s)

• MRONJ healing — 12 months
  Evaluation of disease recurrence over the following 12 months: this evaluation will be performed clinically (absence of symptoms, absence of exposed bone in the oral cavity, and other minor clinical signs) and radiographically through a routinely required 3D radiographic exam (CBCT or CT).

Trial sites (1)

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