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

NCT02201498.

Trial name or title Randomized Clinical Trial for Primary Molar Pulpotomy, Biodentine versus Formocresol‐ZOE
Methods None
Participants Inclusion criteria
  • ASA I and II

  • Less than 1/3 of physiologic root resorption

  • Asymptomatic tooth (with no history of symptoms)

  • No clinical or radiological sign of pathology

  • Vital tooth, with carious pulpal exposure

  • Haemostasis must be obtained simply with pressure in less than 5 min

  • Teeth restored with stainless steel crowns

  • Up to 10 years (child)


Exclusion criteria
  • More than 10 years old

  • Symptomatic tooth (presently or history of symptoms)

  • Previous pulpal treatment on the tooth

  • Necrotic pulp

  • Hyperemic pulp

  • Inadequate operative technique, defective restoration

  • Non diagnostic x‐ray (pre or post treatment)

Interventions
  • Active comparator: Formocresol/OZE Conventional pulpotomy technique, with formocresol and zinc oxide eugenol Intervention: procedure: pulpotomies with Formocresol/OZE and Biodentine

  • Active comparator: Biodentine New technique, with biodentine Intervention: procedure: pulpotomies with Formocresol/OZE and Biodentine

Outcomes
  • Clinical success (time frame: 12 months post treatment)

  • Radiographic success (time frame: 12 months post treatment)

Starting date September 2014
Contact information None
Notes