Huth 2005.
Methods | RCT, parallel‐arm Teeth randomly assigned Conducted in the Pedodontic Section, Department of Restorative Dentistry and Periodontology, Ludwig‐Maximilians‐University, Munich, Germany. Operators were 2 paedodontists |
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Participants | 107 children, 191 teeth, mean age 4.8 years, standard deviation age 1.6 years, age range 2 to 8 years | |
Interventions |
Group 1:Pulpotomy (formocresol); n = 50 (1 visit)
Group 2:Pulpotomy (Er:YAG); n = 47 (1 visit)
Group 3:Pulpotomy (calcium hydroxide); n = 44 (1 visit)
Group 4:Pulpotomy (ferric sulphate); n = 50 (1 visit)
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Outcomes | Clinical failure (spontaneous pain, tenderness to percussion, fistula, soft tissue swelling, and pathological tooth mobility), spontaneous pain, tenderness to percussion, swelling, fistula, pathological mobility: evaluation at 6, 12, 18 and 24 months Radiological failure (periapical or furcal radiolucency, pathological external or distinct internal root resorption, or widened periodontal ligament space), signs of failure (spontaneous pain, tenderness to percussion, fistula, soft tissue swelling, pathological tooth mobility, periapical or furcal radiolucency, pathological external or distinct internal root resorption, or widened periodontal ligament space), furcal radiolucency, periapical radiolucency, internal root resorption, external root resorption, periodontal ligament widening: evaluation at 12 and 24 months (at tooth level) |
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Notes | Reasons of dropouts: "103 patients (191 teeth followed up): 3 teeth from the laser group and 6 from the calcium hydroxide group were excluded from follow‐up and statistical analysis, due to uncontrollable bleeding during radiation or placement of calcium hydroxide, since a hyperemic, inflamed radicular pulp is considered a contraindication for vital pulpotomy"; "12 teeth had exfoliated physiologically" Comment: quotes: "4 patients moved away" Source of funding: quote: "The study was completely financed by Departmental funding". (Department of Restorative Dentistry & Periodontology, Dental School, Ludwig‐Maximilians‐University, Munich) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "...by an assistant casting a concealed lot from a box containing 4 x 50 lots (block randomization)" |
Allocation concealment (selection bias) | Low risk | Quote: "...all other contributors for the study were blinded to generation and implementation of the treatment assignment" |
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: "clinical re‐evaluations …were performed independently by two experienced dentists (not the operators) blinded to the technique"; "the outcome assessment and data analysis were blinded, since the techniques were indistinguishable and coded" |
Blinding of radiological outcomes assessment | Low risk | Quote: "radiographic examinations were performed independently by two experienced dentists (not the operators) blinded to the technique"; "the outcome assessment and data analysis were blinded, since the techniques were indistinguishable and coded" |
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 |