NCT02201498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

July 24, 2014

Last Update Submit

January 10, 2018

Conditions

Deep Dental Caries

Outcome Measures

Primary Outcomes (2)

  • clinical success

    12 months post treatment

  • radiographic success

    12 months post treatment

Study Arms (2)

Formocresol/OZE

ACTIVE COMPARATOR

Conventional pulpotomy technique, with formocresol and zinc oxide eugenol

Procedure: Pulpotomies with Formocresol/OZE and Biodentine

Biodentine

ACTIVE COMPARATOR

New technique, with biodentine

Procedure: Pulpotomies with Formocresol/OZE and Biodentine

Interventions

Pulpotomies with Formocresol/OZE and BiodentinePROCEDURE
BiodentineFormocresol/OZE

Eligibility Criteria

AgeUp to 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, h3t1c5, Canada

Location

MeSH Terms

Interventions

Pulpotomytricalcium silicate

Intervention Hierarchy (Ancestors)

EndodonticsDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2014

First Posted

July 28, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations

CA(1)