NCT01591278
Unknown
Phase 4
Clinical and Radiographic Outcomes of MTA and Biodentine in Pulpotomized Primary Molars. A Randomized Clinical Trial
Cristina Cuadros1 site in 1 country80 target enrollmentStarted: March 2012Last updated:
ConditionsPrimary Molar Pulpotomy
Overview
- Phase
- Phase 4
- Sponsor
- Cristina Cuadros
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Number of molars with clinical success
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 and any history of allergic reaction to latex, local anaesthetics or to the constituents of the test pulp dressing agents
Outcomes
Primary Outcomes
Number of molars with clinical success
Time Frame: 12 months
Number of molars with radiographic success
Time Frame: 6 and 12 months
Secondary Outcomes
- Number of molars with no evidence of radicular radiolucency(6 and 12 months)
- Number of molars with no evidence of internal resorption(6 and 12 months)
- Number of molars with no evidence of external resorption(6 and 12 months)
- Number of molars with no evidence of furcation radiolucency(6 and 12 months)
- Number of molars with no symptoms of pain(6 and 12 months)
- Number of molars without swelling(6 and 12 months)
- Number of molars without fistulation(6 and 12 months)
- Number of molars without pathological mobility.(6 and 12 months)
Investigators
Cristina Cuadros
Cristina Cuadros Fernández
Universitat Internacional de Catalunya
Study Sites (1)
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