- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01962077
Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth.
July 1, 2021 updated by: Hadassah Medical Organization
Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth
assess the effect of MedCem MTA as a pulp medicament following pulpotomy in human primary molars with carious pulp exposure in comparison to Formocresol.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Jerusalem, Israel, 91120
- Hadassah Medical Organization
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 10 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MedCem MTA pulpotomies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success of MedCem MTA pulpotomy in primary molar
Time Frame: Up to 36 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (ACTUAL)
June 1, 2021
Study Completion (ACTUAL)
June 1, 2021
Study Registration Dates
First Submitted
September 25, 2013
First Submitted That Met QC Criteria
October 10, 2013
First Posted (ESTIMATE)
October 14, 2013
Study Record Updates
Last Update Posted (ACTUAL)
July 6, 2021
Last Update Submitted That Met QC Criteria
July 1, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Nathalie- HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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