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MTA and Biodentine in Pulpotomized Primary Molars

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ClinicalTrials.gov Identifier: NCT01591278
Recruitment Status : Unknown
Verified November 2014 by Cristina Cuadros, Universitat Internacional de Catalunya.
Recruitment status was:  Active, not recruiting
First Posted : May 3, 2012
Last Update Posted : November 13, 2014
Sponsor:
Information provided by (Responsible Party):
Cristina Cuadros, Universitat Internacional de Catalunya

Brief Summary:
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 or disease Intervention/treatment Phase
Primary Molar Pulpotomy Other: Pulpotomy Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Radiographic Outcomes of MTA and Biodentine in Pulpotomized Primary Molars. A Randomized Clinical Trial
Study Start Date : March 2012
Primary Completion Date : February 2014
Estimated Study Completion Date : November 2014

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of molars with clinical success [ Time Frame: 12 months ]
  2. Number of molars with radiographic success [ Time Frame: 6 and 12 months ]

Secondary Outcome Measures :
  1. Number of molars with no evidence of radicular radiolucency [ Time Frame: 6 and 12 months ]
  2. Number of molars with no evidence of internal resorption [ Time Frame: 6 and 12 months ]
  3. Number of molars with no evidence of external resorption [ Time Frame: 6 and 12 months ]
  4. Number of molars with no evidence of furcation radiolucency [ Time Frame: 6 and 12 months ]
  5. Number of molars with no symptoms of pain [ Time Frame: 6 and 12 months ]
  6. Number of molars without swelling [ Time Frame: 6 and 12 months ]
  7. Number of molars without fistulation [ Time Frame: 6 and 12 months ]
  8. Number of molars without pathological mobility. [ Time Frame: 6 and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591278


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