Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2011-10-04
2016-02-29
Brief Summary
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Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the former iodoform product.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Biodentine
Pulpotomy using Biodentine as pulpotomy medicine.
Biodentine pulpotomy
White Mineral trioxide Aggregate (MTA)
Pulpotomy using white MTA as pulpotomy medicine.
White MTA pulpotomy
Tempophore
Pulpotomy using Tempophore as pulpotomy medicine in a control group.
Tempophore pulpotomy
Interventions
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Biodentine pulpotomy
White MTA pulpotomy
Tempophore pulpotomy
Eligibility Criteria
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Inclusion Criteria
* Patients without any known medical history of systemic complications contradicting pulp treatment.
* Patients are indicated for treatment under general anaesthesia due to polycaries / fear / anxiety / very young age.
* Written consent is obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes.
2 Years
9 Years
ALL
Yes
Sponsors
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University Ghent
OTHER
Responsible Party
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Principal Investigators
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Luc Martens, PhD, DDS
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Locations
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Ghent University Hospital
Ghent, , Belgium
Countries
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Other Identifiers
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2011/538
Identifier Type: -
Identifier Source: org_study_id