MTA and Biodentine in Pulpotomized Primary Molars

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cristina Cuadros, Universitat Internacional de Catalunya
ClinicalTrials.gov Identifier:
NCT01591278
First received: April 30, 2012
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Primary Molar Pulpotomy
Other: Pulpotomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Radiographic Outcomes of MTA and Biodentine in Pulpotomized Primary Molars. A Randomized Clinical Trial

Further study details as provided by Universitat Internacional de Catalunya:

Primary Outcome Measures:
  • Number of molars with clinical success [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of molars with radiographic success [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of molars with no evidence of radicular radiolucency [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Number of molars with no evidence of internal resorption [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Number of molars with no evidence of external resorption [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Number of molars with no evidence of furcation radiolucency [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Number of molars with no symptoms of pain [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Number of molars without swelling [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Number of molars without fistulation [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Number of molars without pathological mobility. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pulp dressing agent Other: Pulpotomy
Comparison of two different pulp dressing agents
Other Name: Biodentine
Active Comparator: Pulp dressing
MTA
Other: Pulpotomy
Comparison of two different pulp dressing agents

  Eligibility

Ages Eligible for Study:   4 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • molars showing:

    1. symptomless exposure of vital pulp by caries
    2. no clinical or radiographic evidence of pulp degeneration (excessive bleeding from the root canal, internal root resorption, inter-radicular and/or furcal bone destruction)
    3. the possibility of proper restoration of the teeth
    4. no physiological resorption of more than one-third of the root

Exclusion Criteria:

  • presence of systemic pathology and any history of allergic reaction to latex, local anaesthetics or to the constituents of the test pulp dressing agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591278

Locations
Spain
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, Spain, 08195
Sponsors and Collaborators
Cristina Cuadros