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Objective The field of osteonecrosis of the jaws (ONJ) research is relatively young in comparison to that of other medical diagnoses.1 ONJ is of great research interest because there lacks consensus regarding its medical and surgical treatment.2 The purpose of this study was to provide a cross-sectional view of all registered clinical trials enrolling patients with ONJ. The primary aim was to report predictors of trial completion and publication of results. Materials and methods This is a cross-sectional study of ONJ trials registered with ClinicalTrials.gov. For each included entry, trial characteristics and endpoints were recorded. Predictors were enrollment size, etiology, study type, intervention type, sponsor, funding, study locations, number of centers, and specialty of principal investigator. Outcomes were trial status, publication on PubMed, journal of publication, and length of time between endpoints. Associations between predictors and outcomes were evaluated using Chi-squared and T-tests. Results The final sample included 26 trials. Overall, 50% of trials were completed, and 69% of completed trials were published. Three out of 4 terminated trials were suspended due to lack of funding. The median enrollment for completed trials was 149 participants with a mean length of 5.0 years. All trials included MRONJ patients and 26% also included ORNJ patients. The majority of trials were observational (65%), conducted internationally (62%), and involved multiple centers (54%). Published trials had a mean time of 5.9 years between trial start and publication, which was comparable to trial length (P = .90), and appeared in either dental (44%) or cancer (56%) journals. Completion and publication rates were not significantly increased by industry sponsorship/funding, larger enrollment sizes, or multi-center involvement. Oral and maxillofacial surgery was the most represented specialty of principal investigators (56%). Conclusion The majority of completed ONJ trials had their results published in a timely manner. Evidence-based investigation of ONJ is a multidisciplinary and international effort. Among all specialists, oral and maxillofacial surgeons led the most ONJ trials. |
