Orthodontic treatment is important in the management of children affected by cleft lip and/or palate (CL/P). Orthodontic interventions can be undertaken at several developmental stages up to the age of 18. This results in a range of research using a wide array of research outcomes. Orthodontic trials have tended to focus on morphological features of malocclusion, although recently there has been a move to incorporating patient-related outcome measures (PROMS). Because of the variation in available outcome measures the development of agreed, standardized core outcome sets (COS) that are measured as a minimum and reported in all clinical trials of a specific condition should be developed.
The aim of this review was to identify and summarise the outcomes measured in orthodontic studies of children with CL/P and to ascertain whether findings could be used to inform future COS development
Searches were conducted in the Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, LILACS, BBO and ClinicalTrials.gov databases.
Studies involving children aged 5-18 years with non-syndromic CL/P receiving orthodontic treatment were included. Randomised controlled trials (RCTs), controlled clinical trials (CCTs) cohort studies and retrospective designs including retrospective cohort and case-control studies with a minimum of 10 participants were considered.
Two reviewers independently selected studies for inclusion with disagreements being resolved by discussion. Outcomes were classified into the following domains.
- Disease activity (morphological features or changes in malocclusion)
- Physical consequence of malocclusion
- Functional status
- Social outcomes and quality of life
- Health resource utilization
- Adverse effects of treatment
- 40 studies were included, a majority were retrospective, only 1 was a RCT.
- 27 studies (68%) measured morphological features of malocclusion
- 10 studies (25%) measured adverse effects of orthodontic treatment
- 4 studies (10%) measured Functional status
- 3 studies (7.5%) measured physical consequences of malocclusion
- 3 studies (7.5%) measured quality of life
- 2 studies (5%) measured health resource utilization
The authors concluded: –
Few studies concerning patients with CL/P focusing specifically on orthodontic interventions were identified in the present review. Most of the identified outcomes were concerned with measuring morphological treatment-related changes and do not reflect patient perspectives.
This scoping review very nicely summarises the range of outcome measures being used orthodontic therapies in CL/P patients. Perhaps not unexpectedly the majority of outcome measure relate to morphologically related changes. The discussion section raised the potential issues of focusing on the impact and value of orthodontics for CL/P patients given that there are often associated interventions and co-morbidities. Nevertheless, it is worth emphasising that having a COS would be helpful, not just in this area but in other areas of orthodontics and dental research more generally as this would greatly assist between study comparisons and systematic review. All of which would help improve the quality of our evidence-base.
Tsichlaki A, O’Brien K, Johal A, Fleming PS. A scoping review of outcomes related to orthodontic treatment measured in cleft lip and palate. Orthod Craniofac Res. 2017 May;20(2):55-64. doi:10.1111/ocr.12152. Review. PubMed PMID:28414872.
The COMET (Core Outcome Measures in Effectiveness Trials) Initiative