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Completed

NCT Number: NCT02201498

Randomized Clinical Trial for Primary Molar Pulpotomy, Biodentine Vs Formocresol-ZOE

This is a RCT that will compare the clinical and radiographic success of pulpotomies on primary molars between the traditional technique (Formocresol/ZOE) and the new technique with Biodentine. 180 pulpotomies (90 in each group) will be followed for a period of 12 months.

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Key information

Conditions

Deep Dental Caries

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Sainte-Justine

Montreal, Quebec, h3t1c5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • hemostasis must be obtained simply with pressure in less than 5 min
  • teeth restored with stainless steel crowns

Exclusion criteria

  • more than 10 y.o.
  • symptomatic tooth (presently or history of symptoms)
  • previous pulpal treatment on the tooth
  • necrotic pulp
  • hyperemic pulp
  • inadequate operative technique, defective restauration
  • non diagnostic x-ray (pre or post treatment)

Treatment and study plan

Pulpotomies with Formocresol/OZE and Biodentine

Procedure

Primary outcomes

  1. clinical success

    Time frame: 12 months post treatment

  2. radiographic success

    Time frame: 12 months post treatment

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Collaborators

  • Septodont
  • St. Justine's Hospital

Registry information

Official study title

A New Technique for Primary Molar Pulpotomy : A Randomized Clinical Trial Comparing the Radiographic and Clinical Success of the Formocresol-zinc Oxide Eugenol Technique and the Biodentine Technique

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 28, 2014
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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