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NCT04863222 · ClinicalTrials.gov registry record · Phase 4
Clinical and Radiographic Success of MTA vs Biodentine
A Phase 4 study of Indirect Pulp Cap and Pulpotomy, sponsored by Geisinger Clinic.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 646
- Enrollment target
- 1
- Study location
NCT04863222: Recruiting Phase 4 study of Indirect Pulp Cap and Pulpotomy, sponsored by Geisinger Clinic.
NCT04863222 is a Phase 4 study of Indirect Pulp Cap and Pulpotomy that is actively recruiting participants, run by Geisinger Clinic. The registered enrollment target is 646 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (25% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04863222, a Phase 4 study of Indirect Pulp Cap and Pulpotomy, is actively recruiting participants, sponsored by Geisinger Clinic.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 646 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this prospective study is to compare the clinical and radiographic success of MTA and Biodentine as a medicament in vital pulp therapy in maxillary and mandibular primary molars in a pediatric population. There is limited research currently on Biodentine since it's a novel product. Biodentine is less expensive than MTA and does not cause discoloration like MTA. Biodentine may be an alternative medicament used for vital pulp therapy in primary molars.
Primary Outcome
To compare the rate of clinical success in primary molars using MTA versus Biodentine in pulpotomies and indirect pulp caps. Subjects will been seen at follow-up standard of care visits every 6 months for 3 years to clinically evaluate if the treatment was successful, if any discoloration has occurred and assess for any signs or symptoms of an abscess.
Conditions Studied
Interventions
- DEVICE Biodentine
- BIOLOGICAL mineral trioxide aggregate (MTA)
Study Locations (1)
Pennsylvania
- Geisinger - Danville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 646 participants |
| Start Date | 2021-11-12 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 4 |
What NCT04863222 shows while recruiting
NCT04863222 is an interventional study that assigns participants to a tested intervention. The registered 646 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (25% higher).
The record links to 2 conditions, with Indirect Pulp Cap appearing as the primary indexed condition, and to 2 interventions - of which Biodentine is the first listed.
NCT04863222 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04863222 about?
NCT04863222 is a clinical study titled "Clinical and Radiographic Success of MTA vs Biodentine". The purpose of this prospective study is to compare the clinical and radiographic success of MTA and Biodentine as a medicament in vital pulp therapy in maxillary and mandibular primary molars in a pediatric population. There is limited research currently on Biodentine since it's a novel product. Bi...
What is the current status of trial NCT04863222?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 646 participants. The study started on 2021-11-12. Estimated completion is 2026-12-01.
What conditions does trial NCT04863222 study?
This clinical trial studies the following conditions: Indirect Pulp Cap, Pulpotomy.
What interventions are being tested in trial NCT04863222?
The interventions under investigation include: Biodentine (DEVICE), mineral trioxide aggregate (MTA) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04863222?
This trial is sponsored by Geisinger Clinic, which has 107 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04863222 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04863222's enrollment target sits among peer trials
646 125th of 2000 higher than 1,876 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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