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. 2015 Mar 31;2015(3):CD008694. doi: 10.1002/14651858.CD008694.pub2

Villa 1997.

Study characteristics
Methods Location: USA
Setting: secondary care
No mention of funding or ethical approval
Participants Children aged 8 to 18 yrs
Participants were selected following screening "Twenty‐four patients between the ages of 6 and 18 years with digit‐sucking habits were selected within a 4‐month screening period from the patient population at Montefiore Medical Center, Division of Orthodontics, for inclusion in this study."
Digit suckers
24 recruited and analysed
Interventions Palatal crib therapy
There was no mention of the specific design of this appliance therefore it was assumed it was similar in design to that described by Haryett and Larsson (n = 12).
Control
This group received no treatment (n = 12)
Pretreatment records were taken for the participants and included study models, OPT, lateral cephalogram radiographs, and intra and extra oral photographs. After 3 months, study models were again taken and compared with the pretreatment ones.
Outcomes 1. Reduction in anterior open bite, in mm, calculated by comparing measurements from the pre and post intervention study models
2. Reduction in overjet, in mm, calculated by comparing measurements from the pre and post intervention study models
3. Change in arch length, in mm, calculated by comparing measurements from the pre and post intervention study models
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "assigned randomly"
Allocation concealment (selection bias) Unclear risk Method of concealment was not described
Blinding of participants and personnel (performance bias)
Patient High risk Blinding of child participant not possible
Blinding of participants and personnel (performance bias)
Operator High risk Blinding not possible
Blinding of outcome assessment (detection bias)
All outcomes Low risk "The evaluator was blinded as to group status of each study model."
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Drop‐out rates were not reported, although it was implied that all children were followed up. The results section states "Overall 10 males and 14 females were studied."
Selective reporting (reporting bias) Low risk Outcomes were clearly defined and all reported.
Other bias Unclear risk Patients were recruited from an orthodontic department patient population. Unclear if sample would be representative of general population.

yrs = years