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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02201498
Enrollment
180
Registered
2014-07-28
Start date
2014-09-30
Completion date
2016-06-30
Last updated
2018-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Dental Caries

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.

Interventions

PROCEDUREPulpotomies with Formocresol/OZE and Biodentine

Sponsors

Septodont
CollaboratorINDUSTRY
St. Justine's Hospital
CollaboratorOTHER
Université de Montréal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
clinical success12 months post treatment
radiographic success12 months post treatment

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026