Reporting Criteria for Clinical Trials on Medication-Related Osteonecrosis of the Jaw (MRONJ): A Review and Recommendations

Abstract

Medication-related osteonecrosis of the jaw (MRONJ) is a complication caused by anti-resorptive agents and anti-angiogenesis drugs. Since we wanted to write a protocol for a randomized clinical trial (RCT), we reviewed the literature for the essential information needed to estimate the size of the active patient population and measure the effects of therapeutics. At the same time, we designed a questionnaire intended for clinicians to collect detailed information about their practices. Twelve essential criteria and seven additional items were identified and compiled from 43 selected articles. Some of these criteria were incorporated in the questionnaire coupled with data on clinical practices. Our review found extensive missing data and a lack of consensus. For example, the success rate often combined MRONJ stages, diseases, and drug treatments. The occurrence date and evaluation methods were not harmonized or quantitative enough. The primary and secondary endpoints, failure definition, and date coupled to bone measurements were not well established. This information is critical for writing a RCT protocol. With this review article, we aim to encourage authors to contribute all their findings in the field to bridge the current knowledge gap and provide a stronger database for the coming years.

Improvement of Quality of Life after Surgical Treatment of Patients with MRONJ: A Prospective Analysis Using the SF-12 and OHIP-14 Questionnaires

“…There are confounding factors that affect the validity of our results. The main limitation is the small number of patients, which was due to the low incidence of MRONJ in the general population [ 3 – 5 ]. This finding contrasts with the findings of the other studies mentioned above, in which patient numbers were comparable [ 11 , 21 , 22 ].…”

“…The term ARONJ was changed to the term “medication-related osteonecrosis of the jaw” (MRONJ) [ 2 ]. The incidence of NAFLD varies in the literature, ranging from 0.4% to 28% [ 3 – 5 ].…”

A systematic review of oral wound healing indices

“…Wound healing is crucial for successful periodontal and implant surgery, especially for soft and hard tissue regenerative procedures which are more commonly practiced nowadays [ 7 ]. Favorable wound healing starts with early formation, organization, stabilization, and attachment of the blood clot.…”

“…It must be able to resist mechanical forces acting on the wound. The degree of clot stability is influenced by the host response, local anatomical features, constant bacterial challenge, surgical trauma severity, and wound closure management [ 7 , 8 ]. Sutures, used to close the wound edges, must remain stable and passive to ensure proper closure without impairing the physiological aspects of wound healing [ 9 , 10 ].…”

“…Prolonged healing or deviated healing events may result in increased complications, patient morbidity, and procedure failures, which negatively affect patients’ quality of life. Therefore, wound healing monitoring for early identification of abnormalities and interventions is a necessity [ 7 , 11 ].…”