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Clinical Trials/NCT02291120
NCT02291120
Unknown
Phase 4

MEDCEM PC and MTA in Pulpotomies of Primary Molars

Universitat Internacional de Catalunya1 site in 1 country80 target enrollmentMarch 2014

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Evaluate the Effects of MEDCEM PC and MTA in Pulpotomies of Primary Molars.
Sponsor
Universitat Internacional de Catalunya
Enrollment
80
Locations
1
Primary Endpoint
Clinical success
Last Updated
11 years ago

Overview

Brief Summary

The objective of the study is to evaluate and compare, clinically and radiographically,the effects of MEDCEM PC and MTA when used as pulp dressings following pulpotomy in human primary molars.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
December 2016
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cristina Cuadros

Master's Program Director in Pediatric Dentistry

Universitat Internacional de Catalunya

Eligibility Criteria

Inclusion Criteria

  • healthy children
  • molars showing: symptomless exposure of vital pulp by caries no clinical or radiographic evidence of pulp degeneration (excessive bleeding from the root canal, internal root resorption, inter-radicular and/or furcal bone destruction) the possibility of proper restoration of the teeth no physiological resorption of more than one-third of the root

Exclusion Criteria

  • presence of systemic pathology
  • history of allergic reaction to latex, local anaesthetics or to the constituents of the test pulp dressing agents

Outcomes

Primary Outcomes

Clinical success

Time Frame: 24 months

No pain, no swelling, no fistula or sinus tract, no pathologic mobility

Radiographic success

Time Frame: 24 months

No internal root resorption progressing into the bone, no external root resorption, no furcation and/or periapical bone destruction

Study Sites (1)

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