Orthodontic Clinical Trials III: reporting of ethical issues associated with clinical trials published in three orthodontic journals between 1989 and 1998.

AIMS: The aims of this study were to assess whether reports of orthodontic clinical trials complied with the requirements of the Declaration of Helsinki.

DESIGN: A retrospective observational study.

SETTING: The American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), Journal of Orthodontics (formerly and up until 1999 known as the British Journal of Orthodontics, BJO) and European Journal of Orthodontics (EJO).

DATA SOURCE: Clinical trials published between 1989 and 1998.

METHODS: A hand search was performed to identify all clinical trials. Each trial report was assessed for inclusion of a statement that ethical approval and/or informed consent had been obtained.

RESULTS: One-hundred-and-fifty-five papers were identified, of which 85 (54.8%) were reports of randomized controlled trials (RCTs) and 70 (45.2%) of controlled clinical trials (CCTs). 16.1% (25/155), of the trial reports stated that ethical approval had been obtained and a quarter (39/155, 25.1%) indicated that informed consent had been obtained.

CONCLUSIONS: Most orthodontic clinical trial reports failed to state whether ethical approval and/or informed consent had been obtained. The reporting of the ethical issues associated with orthodontic clinical trials could be improved further not only by the instructions to authors in orthodontic journals stating the need for studies to comply with the Declaration of Helsinki, but also by Journal editors refusing to publish trials that do not comply.