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Clinical Trials/NCT02201498
NCT02201498
Completed
Not Applicable

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

Université de Montréal1 site in 1 country180 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deep Dental Caries
Sponsor
Université de Montréal
Enrollment
180
Locations
1
Primary Endpoint
clinical success
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
June 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

clinical success

Time Frame: 12 months post treatment

radiographic success

Time Frame: 12 months post treatment

Study Sites (1)

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