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Clinical and Radiographic Success of MTA vs Biodentine

NCT ID: NCT04863222

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

646 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-12

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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This is a interventional randomized split mouth prospective study that evaluates the clinical and radiographic success of mineral trioxide aggregate (MTA) and Biodentine as pulpotomy and indirect pulp cap (IPC) medicaments. Male and female participants ages two to twelve who need at least two quadrants of treatment will be enrolled in the trial. Participants will be treated at Geisinger Medical Center, Danville, and Geisinger Bloomsburg Hospital operating rooms for full mouth rehabilitation. Each participant must have at least two matched bilateral carious primary molars that require either pulpotomy or indirect pulp cap. Maxillary and mandibular primary first and second molars who receive pulpotomy and /or indirect pulp cap will be compared. The research will be split mouth design where the primary molar on one side will get MTA as the pulpotomy or IPC medicament and the corresponding primary on the other side will get Biodentine as the pulpotomy or IPC medicament in the same arch.

The procedures will be performed according to standards of the American Academy of Pediatric Dentistry (AAPD), by Institutional Review Board approved investigators. Data will be extracted from the electronic health record (EHR) and TigerView dental radiograph imaging software. Data will be recorded using REDCap. Clinical and radiographic follow up of patients will be every 6 months since date of procedure for 3 years. Follow up will be done at the Geisinger Pediatric Dental Clinic at Danville or Milton.

Conditions

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Indirect Pulp Cap Pulpotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MTA, then Biodentine

The participant will receive the standard of care procedure using MTA in on a right primary molar. A left primary molar will then be treated using Biodentine.

Group Type EXPERIMENTAL

Biodentine

Intervention Type DEVICE

During a patients procedure, one tooth will receive Biodentine instead of MTA.

mineral trioxide aggregate (MTA)

Intervention Type BIOLOGICAL

mineral trioxide aggregate (MTA)

Biodentine, then MTA

Investigators will prepare and treat a participants right primary molar with Biodentine. The participant will then receive the standard of care procedure using MTA in on a left primary molar.

Group Type EXPERIMENTAL

Biodentine

Intervention Type DEVICE

During a patients procedure, one tooth will receive Biodentine instead of MTA.

mineral trioxide aggregate (MTA)

Intervention Type BIOLOGICAL

mineral trioxide aggregate (MTA)

Interventions

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Biodentine

During a patients procedure, one tooth will receive Biodentine instead of MTA.

Intervention Type DEVICE

mineral trioxide aggregate (MTA)

mineral trioxide aggregate (MTA)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Geisinger Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gayatri Malik, DMD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

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Geisinger

Danville, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Gayatri Malik, DMD

Role: CONTACT

Phone: 570-271-6355

Email: [email protected]

Samantha R Crissinger

Role: CONTACT

Phone: 570-271-7499

Email: [email protected]

Facility Contacts

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Gayatri Malik, DMD

Role: primary

Other Identifiers

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2019-0994

Identifier Type: -

Identifier Source: org_study_id