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NCT Number: NCT04863222

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. 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.

Recruiting

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Key information

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Geisinger

Danville, Pennsylvania, 17822, United States

Location status: Recruiting

Location contact

Gayatri Malik, DMD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biodentine

Device

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

mineral trioxide aggregate (MTA)

Biological

mineral trioxide aggregate (MTA)

Primary outcomes

  1. Rate of clinical success in pulpotomies and indirect pulp caps

    Time frame: 4 years

    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.

  2. Rate of radiographic success in pulpotomies and indirect pulp caps

    Time frame: 4 years

    To compare the rate of radiographic 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 where x-rays will be taken to determine if any abscess have formed.

Study contacts

Contact information is provided by the study sponsor or research team.

Gayatri Malik, DMD

CONTACT

[email protected]

570-271-6355

Samantha R Crissinger

CONTACT

[email protected]

570-271-7499

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

Clinical and Radiographic Success of Mineral Trioxide Aggregate (MTA) vs Septodont Biodentine in Primary Molars in Pulpotomy and Indirect Pulp Cap Treatments

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2021
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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