Hutcheson 2012.
Methods | RCT, split‐mouth study, with 1‐year follow‐up Unit of randomisation: teeth |
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Participants |
Setting: Recruited from 2 dental clinics in Texas, 15 treated in clinic, 25 treated in operating theatre. Single site. Single operator Sample size Number screened: not reported Number eligible: not reported Number randomised: 40 participants (80 teeth) Number analysed: 37 participants (74 teeth) at 6 months, 31 participants (62 teeth) at follow‐up Sex: not reported Age: mean 5.1 years old (range 2.6 to 8) Teeth/lesions: "large carious lesions of similar size approaching the pulp" Inclusion criteria for participants:
Inclusion criteria for teeth:
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Interventions |
Intervention: stainless steel crown Control: resin composite multi‐surface, fitted using open sandwich technique. A layer of glass ionomer was used to cover the MTA before resin was applied All participants had MTA pulpotomy All teeth had pulptomies carried out before the crowns or restorations were placed |
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Outcomes | Outcomes assessed at 6 months and 12 months:
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Source of Funding | No information provided | |
Declaration of interest | No information provided | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A tooth in each pair was randomly allocated by coin toss to either the experimental group (MTA/composite) or the control group (MTA/SSC), with the contralateral‐paired tooth assigned to the other treatment" |
Allocation concealment (selection bias) | Low risk | Coin toss provided adequate concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: No blinding, participant and operator aware of different treatments. Blinding to type of treatment was not possible as the restorations look different. Unclear whether this affected level or quality of care |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "All pre‐ and postoperative radiographs were either digital or digitally scanned and evaluated by 2 blinded, standardized, and calibrated examiners. Coronal portions of the treated teeth were blackened‐out to ensure that the examiners were blinded." Comment: Blinding adequate for radiological findings, but most of the outcomes (clinical and patient‐reported) could not be blinded in the assessment |
Incomplete outcome data (attrition bias) All outcomes | High risk | Dropouts were participants who failed to return, despite reminders 31/40 participants (77.5%) available at 12 months, 37/40 (92.5%) available at 6 months Percentage of losses quite large compared to the effect size of the trial |
Selective reporting (reporting bias) | Unclear risk | All outcomes outlined in methods section were reported. Provided scale used for radiological ratings Definitions of 'radiologically successful' and 'clinically successful' were not provided |
Other bias | Low risk | No other potential biases detected |