Piezoeletric Surgery vs Conventional Surgery for Treatment of MRONJ

NCT06622421 | Not Yet Recruiting

• 1 other identifier: 5786
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Bisphosphonate-Associated Osteonecrosis of the Jaw; Osteonecrosis of the Jaw; Osteonecrosis Due to Drug

Keywords

MEDICATION RELATED OSTEONECROSIS OF THE JAW; SURGICAL TREATMENT OF MRONJ; MRONJ

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Secondary Outcomes (9)

• operators discomfort

  at the end of surgery

• ambient noise

  during the surgery

• duration of the surgery

  during the surgery

• correlation between clinical parameters and patient's perception

  8 hours after surgery and then at 7 and 21 days after surgery

• Risk factors

  8 hours after surgery and then at 7 and 21 days after surgery

Study Arms (2)

G1 - control group

OTHER

Patients with MRONJ diagnosis who will undergo to conventional surgery using rotary burns instruments

Procedure: Conventional surgery

G2 - study group

EXPERIMENTAL

Patients with MRONJ diagnosed who will undergo to piezoelectric surgery

Device: Piezoelectric surgery

Interventions

Piezoelectric surgery DEVICE

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

G2 - study group

Conventional surgery PROCEDURE

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

G1 - control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Patients undergoing retreatment of MRONJ;
• Patients with general medical contraindications for oral surgery procedures;
• Patients unable to attend the outpatient visits required by the protocol.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Catholic University

Roma, 00168, Italy

Location

Related Publications (7)

• Marx RE. Pamidronate (Aredia) and zoledronate (Zometa) induced avascular necrosis of the jaws: a growing epidemic. J Oral Maxillofac Surg. 2003 Sep;61(9):1115-7. doi: 10.1016/s0278-2391(03)00720-1. No abstract available.

  PMID: 12966493 BACKGROUND

• Mavrokokki T, Cheng A, Stein B, Goss A. Nature and frequency of bisphosphonate-associated osteonecrosis of the jaws in Australia. J Oral Maxillofac Surg. 2007 Mar;65(3):415-23. doi: 10.1016/j.joms.2006.10.061.

  PMID: 17307586 BACKGROUND

• Yarom N, Fedele S, Lazarovici TS, Elad S. Is exposure of the jawbone mandatory for establishing the diagnosis of bisphosphonate-related osteonecrosis of the jaw? J Oral Maxillofac Surg. 2010 Mar;68(3):705. doi: 10.1016/j.joms.2009.07.086. No abstract available.

  PMID: 20171493 BACKGROUND

• Ruggiero SL, Dodson TB, Fantasia J, Goodday R, Aghaloo T, Mehrotra B, O'Ryan F; American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on medication-related osteonecrosis of the jaw--2014 update. J Oral Maxillofac Surg. 2014 Oct;72(10):1938-56. doi: 10.1016/j.joms.2014.04.031. Epub 2014 May 5.

  PMID: 25234529 BACKGROUND

• Colella G, Campisi G, Fusco V. American Association of Oral and Maxillofacial Surgeons position paper: Bisphosphonate-Related Osteonecrosis of the Jaws-2009 update: the need to refine the BRONJ definition. J Oral Maxillofac Surg. 2009 Dec;67(12):2698-9. doi: 10.1016/j.joms.2009.07.097. No abstract available.

  PMID: 19925998 BACKGROUND

• El-Rabbany M, Sgro A, Lam DK, Shah PS, Azarpazhooh A. Effectiveness of treatments for medication-related osteonecrosis of the jaw: A systematic review and meta-analysis. J Am Dent Assoc. 2017 Aug;148(8):584-594.e2. doi: 10.1016/j.adaj.2017.04.002. Epub 2017 May 18.

  PMID: 28527518 BACKGROUND

• Labanca M, Azzola F, Vinci R, Rodella LF. Piezoelectric surgery: twenty years of use. Br J Oral Maxillofac Surg. 2008 Jun;46(4):265-9. doi: 10.1016/j.bjoms.2007.12.007. Epub 2008 Mar 14.

  PMID: 18342999 BACKGROUND

MeSH Terms

Conditions

Bisphosphonate-Associated Osteonecrosis of the Jaw

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlo Lajolo, MD,DDS

  Catholic University of Rome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Lajolo, MD,DDS, PhD

CONTACT

3356078354; carlo.lajolo@unicatt.it

Gioele Gioco, DDS

CONTACT

3288486585; gioele.gioco@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The collaborator who will collect the data and the statistician will not be aware of the assignment group. Each patient will be identified with a unique code (PIEZOPZ\ n.) that will be known only to the principal investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective randomized and controlled study with parallel groups (1:1) of superiority

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: October 2, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 22, 2025

Record last verified: 2024-09

Locations

IT (1)