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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: Completed Early Phase 1 study, sponsored by Virginia Commonwealth University.
NCT05557812 is a Early Phase 1 study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 19 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility.
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 |
What the finished NCT05557812 record still lists
NCT05557812 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (64% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05557812's enrollment target sits among peer trials
19 1292nd of 2000 higher than 686 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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