title: A systematic review of outcome measures used in clinical trials of treatment interventions following traumatic dental injuries.
abstract: BACKGROUND
  Traumatic dental injuries (TDI) are common, and appropriate treatment will maximize the chances of maintaining teeth in function while safeguarding their longevity and aesthetics. Subjectively, it appears that outcome measures used in studies investigating TDI are numerous and diverse.
  
  
  OBJECTIVE
  To undertake a systematic review of the outcomes used in clinical trials of treatment interventions following TDI.
  
  
  METHODS
  The MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews and EMBASE databases were searched up to June 2014. Reference lists of eligible studies were cross-checked to identify additional studies and strategies to identify grey literature and ongoing trials were employed.
  
  
  METHODS
  Two authors independently assessed studies for inclusion and undertook data extraction. The study designs included were as follows: systematic reviews with/without meta-analyses, randomized and pseudo-randomized controlled trials and controlled clinical trials. There were no language restrictions.
  
  
  RESULTS
  Ten studies confined to two types of TDI were included: avulsion (5) and non-vital immature permanent incisor teeth (5). The outcomes reported predominantly concentrated on injury activity and the physical consequence of injury. There was little consistency between studies for the length of follow up, the time points at which outcomes were evaluated or the methods used to measure them.
  
  
  CONCLUSIONS
  There is significant heterogeneity in outcomes reported for TDI in the literature. These findings preclude meaningful meta-analysis between studies. Future clinical studies need to consider collecting a more consistent and wider range of outcomes, which should include one or more from each of the following domains: health resources utilisation, adverse effects and quality of life and family outcome. There is a clear need for the development of a Core Outcome Set for TDI using robust and established methodology, thus optimizing the value of future research.
authors.affiliation: Department of Orthodontics, Eastman Dental Hospital, London, UK.
authors.forename: Mohammad Owaise
authors.initials: MO
authors.lastname: Sharif
authors.affiliation: General Dental Practitioner, Orford, Warrington, WA2 7QJ, Cheshire, UK.
authors.forename: Ambareen
authors.initials: A
authors.lastname: Tejani-Sharif
authors.affiliation: Department of Paediatric Dentistry, School of Dentistry, University of Leeds, UK.
authors.forename: Kate
authors.initials: K
authors.lastname: Kenny
authors.affiliation: Department of Paediatric Dentistry, School of Dentistry, University of Leeds, UK.|Salaried Dental Service, Bradford District Care Trust, Bradford, UK.
authors.forename: Peter F
authors.initials: PF
authors.lastname: Day
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D017063:Outcome Assessment, Health Care; D018677:Tooth Injuries / Q000628:therapy*
keywords: Dental trauma; core outcome set; systematic review; tooth injury; treatment