Holan 2005.
Methods | RCT, parallel‐arm Teeth randomly assigned Conducted in the Pediatric Dentistry Clinic of the Hebrew University‐Hadassah School of Dental Medicine in Jerusalem, Israel. Operators were the authors of this study |
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Participants | 35 children, 64 teeth, mean age 6.5 years, age range 4.4 to 11 years | |
Interventions |
Group 1:Pulpotomy (formocresol); n = 31 (1 visit)
Group 2:Pulpotomy (MTA); n = 33 (1 visit)
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Outcomes | Signs of failure (furcation radiolucency, periapical bone destruction, internal root resorption, swelling or sinus tract), abscess, pulp canal obliteration, dentine bridge formation, furcal radiolucency, periapical radiolucency, internal root resorption, external root resorption, calcific metamorphosis (periapical radiolucency or inter‐radicular radiolucency): evaluation at 36 (range 4 to 74) months (at tooth level) | |
Notes | Reasons of dropouts: "Of the 64 pulpotomized teeth, 62 teeth in 33 children were available for analysis of success/failure rate. 2 molars in 2 patients, both of the FC group, were excluded from the study because the patients never returned for follow‐up examination" Comment: quotes: "when a patient did not respond or broke an appointment, further attempts were made to call the parents and a follow‐up examination was rescheduled"; "the follow‐up period was defined as the time elapsed between treatment and one of the following: 1/detection of pulpotomy failure; 2/naturally exfoliated tooth; 3/patient's last visit for recall examination. Teeth with less than 12 months follow‐up time were excluded from the study, unless a failure was detected during the first postoperative year" Source of funding: not reported, although the MTA material was provided by a colleague at another university in the USA |
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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 | High risk | Quote: "the children were then examined clinically by 1 of the 3 authors who were not blind to which treatment group the assessed tooth belonged" |
Blinding of radiological outcomes assessment | Low risk | Quote: "All 3 authors blindly evaluated the radiographs" |
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 |