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NCT05557812 · ClinicalTrials.gov registry record · Early Phase 1
A Clinical Trial Comparing FS With ZOE and Non-eugenol Based Materials in Primary Teeth Pulpotomies
A Early Phase 1 study, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 19
- Enrollment target
NCT05557812 is a Early Phase 1 study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 19 participants.
The verdict
NCT05557812, a Early Phase 1 study, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
Internal resorption in the most common cause of failure in FS pulpotomies in primary molars. This has been attributed to the release of free eugenol from the zinc and eugenol mixture of the base material over the pulp tissue. Zinc oxide-eugenol (ZOE) paste is the most common base material placed over the infected pulp tissues during pulpotomies of primary molars, however the evidence suggests that the eugenol component has been associated with the failure of the vital pulp treatment in primary molars. Cavit (3M, US) is another base material that contains Zinc-oxide, zinc sulphate, and calcium salts without eugenol. The effectiveness of non-eugenol based Zinc oxide as a base material over ferric sulphate treated pulp has not been explored. The hypothesis is that the non-eugenol based ZOE could be used as an alternate to eugenol based ZOE and thereby avoid the radiological failures. Therefore, this randomized controlled clinical split-mouth trial aimed to evaluate and compare the effect of eugenol and non-eugenol based ZOE on the success of primary tooth pulpotomies where FS is used as a medicament.
Interventions
- DRUG non-eugenol based ZOE base material with Ferric Sulfate in primary molar pulpotomies
- DRUG eugenol based zinc oxide and Ferric Sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2023-02-02 |
| Est. Completion | 2025-02-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05557812
The ClinicalTrials.gov registry entry for NCT05557812 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which non-eugenol based ZOE base material with Ferric Sulfate in primary molar pulpotomies is the first listed.
NCT05557812 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05557812 about?
NCT05557812 is a clinical study titled "A Clinical Trial Comparing FS With ZOE and Non-eugenol Based Materials in Primary Teeth Pulpotomies". Internal resorption in the most common cause of failure in FS pulpotomies in primary molars. This has been attributed to the release of free eugenol from the zinc and eugenol mixture of the base material over the pulp tissue. Zinc oxide-eugenol (ZOE) paste is the most common base material placed ove...
What is the current status of trial NCT05557812?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 19 participants. The study started on 2023-02-02. Estimated completion is 2025-02-01.
What interventions are being tested in trial NCT05557812?
The interventions under investigation include: non-eugenol based ZOE base material with Ferric Sulfate in primary molar pulpotomies (DRUG), eugenol based zinc oxide and Ferric Sulfate (DRUG).
Who is sponsoring clinical trial NCT05557812?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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