NCT04863222 Clinical and Radiographic Success of MTA vs Biodentine
| NCT ID | NCT04863222 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Geisinger Clinic |
| Condition | Indirect Pulp Cap |
| Study Type | INTERVENTIONAL |
| Enrollment | 646 participants |
| Start Date | 2021-11-12 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 646 participants in total. It began in 2021-11-12 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Male or female patients ages of 2 to ≤12 years. * Bilateral symptomatic or asymptomatic vital primary molars with caries approximating or into the pulp. * Patient who need a pulpotomy and/or indirect pulp cap treatments in two or more quadrants. * Parents of patients who can provide consent in English. * Patients who need treatment in an operating room setting at Geisinger. Exclusion Criteria: * Pre-operative radiographic or clinical symptoms associated with irreversible pulpitis or necrotic pulp. * Radiographs not displaying furcation region of the tooth. * Patients with cardiac conditions who need prophylaxis for infective Endocarditis. * Patients with any type of cancer in the past or present. * Non-restorable molars.
Contact & Investigator
Gayatri Malik, DMD
PRINCIPAL INVESTIGATOR
Geisinger Clinic
Frequently Asked Questions
Who can join the NCT04863222 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 12 Years, studying Indirect Pulp Cap. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04863222 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04863222 currently recruiting?
Yes, NCT04863222 is actively recruiting participants. Contact the research team at gmalik1@geisinger.edu for enrollment information.
Where is the NCT04863222 trial being conducted?
This trial is being conducted at Danville, United States.
Who is sponsoring the NCT04863222 clinical trial?
NCT04863222 is sponsored by Geisinger Clinic. The principal investigator is Gayatri Malik, DMD at Geisinger Clinic. The trial plans to enroll 646 participants.