Aminabadi 2010.
Methods | RCT, parallel‐arm Teeth randomly assigned Conducted in the Department of Pediatric Dentistry at Tabriz University of Medical Sciences School of Dentistry, Iran. Operators not mentioned |
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Participants | 84 children, 120 teeth, mean age 4.4 years, age range 4 to 5 years | |
Interventions |
Group 1:Direct pulp capping (formocresol + ZOE); n = 60 (1 visit)
Group 2:Direct pulp capping (calcium hydroxide + ZOE); n = 60 (1 visit)
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Outcomes | Clinical success (spontaneous pain, or pain initiated by stimuli; signs of a defective restoration or recurrent caries; signs of mobility, sinus formation, tenderness to percussion, or soft tissue swelling; and signs of exfoliation, mobility or signs/symptoms of the successor tooth erupting), radiological success (defective restoration or recurrent caries; periradicular pathology such as periapical or furcal radiolucency; and pathological internal resorption, replacement resorption, intracanal calcifications, or physiological root resorption): evaluation at 24 months (at tooth level) Spontaneous pain, tenderness to percussion, fistula or parulis, periapical radiolucency or furcal radiolucency, internal resorption or external resorption: evaluation at 6, 12, 18 and 24 months |
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Notes | ||
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 by not having direct access during [...] clinical evaluation to records detailing which pulp therapy agent was used" |
Blinding of radiological outcomes assessment | Low risk | Quote: "objectivity was maximized by not having direct access during [...] radiological evaluation to records detailing which pulp therapy agent was used" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a clear judgement |