Waterhouse 2000.
Methods | RCT, parallel‐arm Teeth randomly assigned Conducted in the paediatric dental clinic within the Dental Hospital, Newcastle‐upon‐Tyne, UK. Operator not mentioned |
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Participants | 52 children, 84 teeth, mean age 5 years, age range 3.3 to 12.5 years | |
Interventions |
Group 1:Pulpotomy (formocresol); n = 46 (1 visit)
Group 2:Pulpotomy (calcium hydroxide); n = 38 (1 visit)
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Outcomes | Clinical failure (symptoms from the treated tooth reported by the child or parent, spontaneous pain, pain initiated by stimuli, signs of defective restoration or recurrent caries, signs of mobility, sinus formation, tenderness to percussion, soft tissues swelling, signs of exfoliation, mobility or signs/symptoms of the successor tooth erupting), tenderness to percussion, swelling, pathological mobility, sinus tract, secondary caries, defective restoration: evaluation at 6 and 12 months (at tooth level) Radiographic success (defective restoration or recurrent caries, periradicular pathology such as periapical or furcal radiolucency, pathological internal resorption, replacement resorption, intracanal calcifications, physiological root resorption, position and eruption pathway of the permanent successor tooth), periradicular radiolucency, furcal radiolucency, periapical radiolucency, internal resorption, pulp canal obliteration, physiological root resorption, recurrent caries: evaluation at 12 months (at tooth level) |
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Notes | 5 teeth lost to follow‐up Clinical follow‐up: 22.5 months (range 6.1 to 38.5) Radiographic follow‐up: 18.9 months (range 1.3 to 36.9) Source of funding: "This study was supported by The Shirley Glasstone‐Hughes Memorial prize awarded to the authors by the British Dental Association, in September 1993" |
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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 | Low risk | Quote: "Objectivity was maximized during clinical assessment, by not having direct access to records detailing which pulp therapy agent was used" |
Blinding of radiological outcomes assessment | Low risk | Quote: "Objectivity was maximized during radiographic assessment, by not having direct access to records detailing which pulp therapy agent was used" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information to make a clear judgement |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a clear judgement |