Alaçam 2009.
Methods | RCT, parallel‐arm Children randomly assigned Conducted in the University of Gazi Department of Pediatric Dentistry, Turkey. Operators were undergraduate dental students supervised by members of senior staff clinics |
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Participants | 105 children, 105 teeth, mean age 6.4 years, age range 4 to 8 years | |
Interventions |
Group 1:Pulpotomy (formocresol); n = 35 (1 visit)
Group 2:Pulpotomy (calcium hydroxide); n = 35 (1 visit)
Group 3:Pulpotomy (calcium hydroxide/iodoform)n = 35 (1 visit)
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Outcomes | Clinical success (teeth remained asymptomatic, no tenderness to percussion, no sinus tract or no premature tooth loss), radiological success (no furcal or periapical radiolucencies or internal or external root resorption), tenderness to percussion, swelling, spontaneous pain, fistula, internal root resorption, external root resorption, periapical radiolucency, furcal radiolucency, widened periodontal ligament: evaluation at 1, 3, 6, 9 and 12 months (at tooth level) | |
Notes | Quote: "9 children, with 9 pulpotomized molars, failed to return for evaluations and were excluded from the study" "5 bleeding cases were excluded from analysis" Group 1 ‐ received intervention, n = 35; no exclusions Group 2 ‐ received intervention, n = 33; excluded due to uncontrolled bleeding from paste placement n = 2 Group 3 ‐ received intervention, n = 32; excluded due to uncontrolled bleeding from paste placement n = 3 Source of funding: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to make a clear judgement |
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: "Radiographic outcome assessments were made by the primary investigator and 1 independent experienced clinician who was blind to the treatment" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Proportion of missing outcomes < 10% of children randomly assigned |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a clear judgement |