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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 September 2021 |
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Main ID: |
NCT03522051 |
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Date of registration:
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19/04/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure
PULPOTOMY |
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Scientific title:
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Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure |
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Date of first enrolment:
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December 1, 2016 |
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Target sample size:
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109 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03522051 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Jordan
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Contacts
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Name:
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Nessrin A Taha, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Jordan University of Science and Technology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Permanent teeth with mature or immature apices
- Have no significant medical problems
- The tooth should give positive response to cold test and electric pulp test (EPT)
- Probing pocket depth and mobility within normal limits
- No Signs of pulp necrosis including sinus tract or swelling
- Radiographically ; caries either exposing the pulps or reaching more than 2\3 the
distance from the dentino-enamel junction (DEJ) to the pulp
- The tooth can be restored via direct restoration
Exclusion Criteria:
- Medically compromised patients
- Negative response to cold test
- Mobility
- Sinus tract
- Swelling
- Non restorable teeth or badly broken teeth
Age minimum:
7 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulpotomy
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Intervention(s)
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Other: calcium silicate based material,
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Primary Outcome(s)
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Change in pain symptoms
[Time Frame: 2-3 days after the treatment, 3 months, 6 months and 12 months and afterwards up to 5 years.]
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Secondary Outcome(s)
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Periapical normalcy at follow up radiographs .
[Time Frame: 6months , 1 year, 2, 3,4,5 years]
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The tooth and restoration should be present in the mouth
[Time Frame: 3, 6 months, 1 year, 2, 3,4,5 years]
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Secondary ID(s)
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JUST14-4-2018
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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