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. 2018 May 31;2018(5):CD003220. doi: 10.1002/14651858.CD003220.pub3

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
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)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation not mentioned

  • Haemostasis not mentioned

  • No irrigation

  • Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes after pulpotomy, followed by ZOE and IRM before being restored with composite or stainless‐steel crowns


Group 2:Pulpotomy (MTA); n = 33 (1 visit)
  • Rubber dam

  • Caries removal prior to pulpal access

  • Pulp access with high‐speed bur

  • Pulpotomy amputation not mentioned

  • Haemostasis not mentioned

  • No irrigation

  • MTA (3:1 powder:saline ratio) applied after pulpotomy, followed by IRM before being restored with composite, amalgam or stainless‐steel crowns

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
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