Evidence map›Paper›PMID 34660159›Full record

ArticleCureus2021

Outcomes of Clinical Trials on Osteonecrosis of the Jaw.

Brendan W Wu, Kevin C Lee, Steven Halepas, Vasiliki Karlis

Abstract read
In one paragraph

Article in Cureus, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Brendan W WuOral and Maxillofacial Surgery, New York University Langone Health, New York, USA.
Kevin C LeeOral and Maxillofacial Surgery, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, USA.
Steven HalepasOral and Maxillofacial Surgery, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, USA.
Vasiliki KarlisOral and Maxillofacial Surgery, New York University Langone Health, New York, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe purpose of this study was to provide a cross-sectional view of all registered clinical trials enrolling patients with osteonecrosis of the jaw (ONJ). The primary aim was to report predictors of trial completion and publication of results. MATERIALS AND

methodsThis 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 the 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-square tests and t-tests.

resultsThe final sample included 26 trials. Overall, 50% of trials were completed and 69% of completed trials were published. Three out of four terminated trials were suspended due to lack of funding. The median enrollment for completed trials was 149 participants with a mean length of five years. All trials included medication-related osteonecrosis of the jaw (MRONJ) patients and 26% also included osteoradionecrosis of the jaw (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=0.90) 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 dental specialty of principal investigators (56%).

conclusionsThe majority of completed ONJ trials had their results published in a timely manner. Evidence-based investigation of ONJ is a multi-disciplinary and international effort. Among all specialists, oral and maxillofacial surgeons led the most ONJ trials.

Indexed as

bisphosphonate-related osteonecrosis of the jawbronjclinical trialsmedication-related osteonecrosis of the jawmronjnctornjosteoradionecrosis of the jaw

Identifiers

PMID34660159
PMCPMC8516017

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.