Zurn 2008.
Methods | RCT, split‐mouth Teeth randomly assigned Conducted in the Department of Pediatric Dentistry, Baylor College of Dentistry Texas, Health Science Center, Dallas, Texas, USA. Operator were 2 standardised operators |
|
Participants | 23 children, 76 teeth, mean age 5.3 years, standard deviation age 1.7 years, age range 2.3 to 8.5 years | |
Interventions |
Group 1:Pulpotomy (formocresol); n = 38 (1 visit)
Group 2:Pulpotomy (calcium hydroxide); n = 38 (1 visit)
|
|
Outcomes | Clinical success (not clearly defined), radiographic failure (not clearly defined), overall success (the cumulative rate of failure due to clinical abscesses or osseous radiolucencies was calculated for each treatment, as was an overall cumulative rate of success. These calculations were based on the following equation: failure percentage = 100% x (previous failures + new failures)/(previous failures + currently examined teeth)), abscess, internal resorption, internal resorption with perforated form, external resorption, periodontal ligament widening, calcific metamorphosis, bone radiolucency: evaluation at 0 to 6, 7 to 12 and 13 to 24 months (at tooth level) | |
Notes | 3 children were lost due to failure to return for follow‐up Analysed: 20 children, 68 teeth Source of funding: quote: "This research project won the Ralph E. MacDonald (sic) Award at the 2006 AAPD annual session for the most outstanding research presented by a graduate student" |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Coin toss |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to make a clear judgement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information to make a clear judgement |
Blinding of clinical outcomes assessment | Unclear risk | Insufficient information to make a clear judgement |
Blinding of radiological outcomes assessment | Low risk | Quote: "...all postoperative radiographs were digitally scanned and evaluated by 2 standardized and calibrated examiners. To blind the examiners to the treatment regimens, the coronal portions were blackened‐out" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Proportion of missing outcomes > 10% children randomly assigned |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a clear judgement |
CEM: calcium‐enriched mixture; CH: calcium hydroxide; clin: clinically; EMD: enamel matrix derivative; Er‐YAG: erbium:yttrium‐aluminium garnet; FC: formocresol; FS: ferric sulphate; IRM: intermediate restorative material (reinforced zinc oxide and eugenol); MTA: mineral trioxide aggregate; n: number of teeth; PC: Portland cement; RCT: randomised controlled trial; rx: radiographically; ZOE: zinc oxide and eugenol