Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth.
1 other identifier
interventional
60
1 country
1
Brief Summary
assess the effect of MedCem MTA as a pulp medicament following pulpotomy in human primary molars with carious pulp exposure in comparison to Formocresol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2013
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
First Submitted
Initial submission to the registry
September 25, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedFirst Posted
Study publicly available on registry
October 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJuly 6, 2021
June 1, 2021
7.7 years
September 25, 2013
July 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Success of MedCem MTA pulpotomy in primary molar
No pain, no swelling or sinus tract, no internal root resorption progressing into the bone, no furcation and/or periapical bond destruction.
Up to 36 months
Study Arms (1)
MedCem MTA pulpotomies
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- healthy children
- with Asymptomatic primary molars with a deep carious lesion;
- Exposure of a vital pulp by caries;
- No clinical or radiographic evidence of pulp degeneration, such as excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction,swelling, or sinus tract;
- Ability to perform a leakage free restoration of the teeth using stainless steel crown, or amalgam/resin based restoration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Organization
Jerusalem, 91120, Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2013
First Posted
October 14, 2013
Study Start
October 1, 2013
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
July 6, 2021
Record last verified: 2021-06