Comparison of Mineral Trioxide Aggregate (MTA) and 20% Formocresol (FC) in Pulpotomized Human Primary Molars
1 other identifier
interventional
200
1 country
1
Brief Summary
This prospective clinical randomized controlled trial is established to compare the clinical, radiographic, and histological treatment outcomes between MTA and FC in pulpotomized human primary molars at 6, 12, 18, 24 month post-treatment and to test the hypothesis that Gray Mineral Trioxide Aggregate (GMTA) is a viable alternative to Diluted (20%) Formocresol (DFC) in pulpotomies treatment of human primary molars.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 3, 2009
CompletedFirst Posted
Study publicly available on registry
September 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedAugust 23, 2012
August 1, 2012
3.8 years
September 3, 2009
August 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinically and radiographically outcomes
6, 12, 18, and 24 months
Secondary Outcomes (1)
histological outcome
when the subjective tooth physically exfoliates from oral cavity
Study Arms (2)
GMTA
EXPERIMENTAL20% FC
ACTIVE COMPARATORInterventions
Once hemorrhage from the pulp chamber is under control using direct pressure of a sterile cotton pellet, pulp stumps are covered with a MTA paste, obtained by mixing 0.2g GMTA powder with sterile water in a powder to liquid ratio of 3:1 in weight. The GMTA will be then immediately covered with a zinc-oxide eugenol base (IRM) material.
After the pulp hemostasis is achieved with direct pressure of a sterile cotton pellet, a sterile cotton pellet dampened with 20% DFC will be placed in contact with the pulp for 5 minutes, followed by the immediate placement of a zinc-oxide eugenol base (IRM) material.
Eligibility Criteria
You may qualify if:
- Primary first or second molars with normal pulp, reversible, or irreversible pulpitis, that have vital carious pulp exposures due to caries and whose pulp bled upon entering the pulp chamber.
- Teeth in which hemostasis could be achieved with pressure of a saline dampened sterile cotton pellet prior to medicament/material placement.
- No clinical symptoms or evidence of pulp degeneration, such as excessive bleeding from the root canal, history of swelling, mobility, or sinus tracts.
- Patients with percussion sensitivity or spontaneous and persistent pain but where hemostasis could be achieved with pressure of sterile cotton pellet.
- No radiographic signs of internal or external root resorption, inter-radicular and/or periapical bone destruction, or furcation radiolucency.
- No more than one-third physiologic root resorption has occurred.
- Teeth had not previously been pulpally treated.
- Teeth deemed to be restorable with posterior stainless steel crowns.
You may not qualify if:
- Not present
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Taiwan University Hospitallead
- University of Michigancollaborator
Study Sites (1)
Department of Dentistry, National Taiwan University Hospital
Taipei, 10048, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuan-Ling Lee, PhD
Department of Dentistry, National Taiwan University Hospital
- STUDY CHAIR
Hsiao-Hua Chang, MS
Department of Dentistry, National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Dentistry
Study Record Dates
First Submitted
September 3, 2009
First Posted
September 7, 2009
Study Start
September 1, 2009
Primary Completion
July 1, 2013
Study Completion
July 1, 2014
Last Updated
August 23, 2012
Record last verified: 2012-08