Evidence map›Paper›PMID 41400418›Full record

ArticleEuropean journal of orthodontics2025

Do we value the safety of our treatments? An empirical assessment of reporting of Harms in Randomized Controlled Trials in Orthodontics.

Ioanna Georganakis, Vasiliki Koretsi, Theodore Eliades, Despina Koletsi

Abstract read
In one paragraph

Article in European journal of orthodontics, 2025. 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.

Ioanna GeorganakisClinic of Orthodontics and Pediatric Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, Zurich 8032, Switzerland.
Vasiliki KoretsiClinic of Orthodontics and Pediatric Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, Zurich 8032, Switzerland.ORCID 0000-0001-8416-6523
Theodore EliadesClinic of Orthodontics and Pediatric Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, Zurich 8032, Switzerland.ORCID 0000-0003-2313-4979
Despina KoletsiClinic of Orthodontics and Pediatric Dentistry, Center of Dental Medicine, University of Zurich, Plattenstrasse 11, Zurich 8032, Switzerland.ORCID 0000-0001-6280-9372

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo record reporting of harms by authors of randomized controlled trials (RCTs) in indexed orthodontic journals of the Q1 ranking, and explore associations between published reports and several publication characteristics. MATERIALS AND

methodsRCTs from six (6) Q1 indexed orthodontic journals, namely the American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), the European Journal of Orthodontics (EJO), the Angle Orthodontist (ANGLE), Progress in Orthodontics (PIOR), the Korean Journal of Orthodontics (KJO), and the Journal of the World Federation of Orthodontists (JWFO) from January 2020 to December 2024 were included. Data extraction was conducted for outcome and predictor variables such as reporting of harms or otherwise, and other publication characteristics including year of publication, journal, origin of authorship, number of authors, design of the RCT, registration, funding, reporting of patient reported outcome measures (PROMs). Statistical analyses included descriptive statistics, cross-tabulations, and univariable and multivariable logistic regression.

resultsA total of 183 RCTs were included. Twenty four percent of RCTs (44/183) did not report on harms in their publications. A significant association was detected between reporting of harms and journal of publication, with EJO published studies acknowledging pertinent harms almost in their entirety (49/51; 96.1% reported harms; P = .008). RCTs of American affiliated authors were the least likely to report harms (P = .02). Studies reporting on PROMs showed 2.73 higher odds for reporting harms compared with those that did not include PROMs (adjusted odds ratio, OR: 2.73; 95% CI: 1.04, 7.15; P = .04). There was strong evidence that RCTs with registered protocols presented higher odds for reporting harms than nonregistered trials (adjusted OR: 3.68; 95% CI: 1.62, 8.36; P = .002).

conclusionsAlbeit progress has been made, a quarter of orthodontic RCTs still do not include harms in their assessment. Registration, inclusion of PROMs, origin of authorship and journal of publication were significant predictors of harms reporting.

Indexed as

OrthodonticsRandomized Controlled Trials as TopicAuthorshipHumansPeriodicals as TopicPublishingadverse eventsharmsorthodontic rCTspROMsregistrationsafety outcomestransparency

Identifiers

PMID41400418
PMCPMC12706765

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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 Socratic graph.