Initial Management of MRONJ Stages I and II, a Clinical Trial With Detection of Salivary Biomarkers

Summary

Medication-related osteonecrosis of the jaw (MRONJ) is a serious complication in patients receiving antiresorptive therapies, such as Bisphosphonates and Denosumab. It is defined by the presence of exposed bone or a fistula that probes bone in the jaws for a period greater than 8 weeks in patient with a history of current or past antiresorptive or antiangiogenic treatment, and in the absence of prior radiotherapy or maxillary bone metastases. Depending on the severity of the disease 4 stages are described.

On the other hand, although the presence of alterations in the levels of certain biomarkers in saliva has been documented in patients with MRONJ compared to healthy patients, its applicability in clinical practice is still unknown.

Until recently, the status quo favored the adoption of a conservative strategy (non-surgical) for the initial management of patients with stage I and II. However, in recent years, this paradigm has been challenged by multiple authors who report better and more predictable outcomes with surgical treatment.

Based on the hypothesis that patients with MRONJ stage I and II subjected to initial surgical treatment have better results than those undergoing conservative (non-surgical) treatment, te research group has designed a unicentric, quasi-experimental clinical trial where the clinical and radiological outcome at the third month of 2 groups of patients with stages I and II MRONJ undergoing non-surgical treatment (Group 1 / control) versus initial surgical treatment (Group 2 / intervention) will be compared.

Also, the investigators hypothesize that the patients with complete resolution of the disease will also normalize salivary biomarkers levels unlike those with stable or progressive disease, meaning there is a correlation between clinical and biochemical response. Accordingly, the levels of specific salivary biomarkers at baseline and at the third month will be determined and compared with the clinical outcome.

After enrollment patients will be instructed and offered both treatment strategies, and assigned to the corresponding group according to their choice. Patients in group 1 (non-surgical) will receive traditional conservative treatment while patients undergoing surgical treatment will receive the same guidelines of conservative treatment plus surgery according to a specific surgical protocol.

Conditions

• Osteonecrosis of the Jaw, Bisphosphonate Induced
• Osteonecrosis of the Jaw, Bisphosphonate Related

Interventions

PROCEDURE

Surgical treatment

Same guidelines as group 1 (non-surgical) plus surgical treatment according to the following protocol: Specific protocol for surgical treatment * Wide mucoperiosteal flaps and complete surgical excision of necrotic bone together with a mucosa margin of at least 2 mm. * Removal of dental pieces included in the diseased area and regularization of bony margins avoiding leaving sharp edges or spicules. * Secure a two layered waterproof closure without tension (simple or with local flaps). * Samples will be sent for Pathological and microbiological analysis. * Stitches removal after two weeks * Postoperative systemic antibiotic following the mentioned protocol until stitches removal.

Sponsors & Collaborators

• Fundació d'investigació Sanitària de les Illes Balears

  lead OTHER_GOV

Principal Investigators

• MARTA MONJO CABRER, PHD · Fundació d'investigació Sanitària de les Illes Balears

• JOANA RAMIS MOREY, PHD · Fundació d'investigació Sanitària de les Illes Balears

• VICTOR A LASA MENÉNDEZ, MD

• JUAN M ZÁRATE GONZÁLEZ, MD · Fundació d'investigació Sanitària de les Illes Balears

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-01

Primary Completion

2023-10-01

Completion

2024-01-15

Countries

• Spain

Study Locations