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
Ability to understand the information provided and to give free consent;
Age greater than 18 years at the time of diagnosis;
Diagnosis of stage 1 or stage 2 MRONJ, according to the SICMF-SIPMO classification [1];
Need for surgical treatment of MRONJ.
Patients with a previous history of radiotherapy in the head and neck area;
Patients with psychiatric disorders;
Women of childbearing age
Patients in stages of MRONJ other than stage 1 and 2;
Parallel
Piezoelectric surgery
DevicePatients 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
Procedure/SurgeryPatients 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
MRONJ healing
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).
operators discomfort
Assessment of operators discomfort during surgery by submitting a questionnaire at the end of surgery
ambient noise
Assessment of the ambient noise level during the intervention with a Decibel detector (Protmex PT6708)
duration of the surgery
Evaluation of the duration of the surgery (Chronometer) of the osteotomy
correlation between clinical parameters and patient's perception
Assess whether there is a correlation between clinical parameters of healing (modified Landry\'s Healing Index) and patient\'s subjective perception
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