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Comparing MTA and Biodentine for Pediatric Dental Procedures

This study is comparing two materials, mineral trioxide aggregate (MTA) and Biodentine, used in dental procedures for children. These procedures, called pulpotomies and indirect pulp caps, help save teeth when cavities are deep. Researchers want to see if Biodentine, which is newer, less expensive, and doesn't cause tooth discoloration like MTA, works as well. They will look at how well the procedures succeed clinically (how the tooth feels and functions) and radiographically (what X-rays show) over four years. Children aged 2 to 12 who need these dental treatments in an operating room at Geisinger and have parents who can consent in English may be able to join. The study status is currently unclear.

Study design
This is an interventional study where 646 participants will be randomly assigned to receive either MTA or Biodentine in different teeth. It uses a "split-mouth" design, meaning one side of the mouth gets one material and the other side gets the other.
What's involved
Participants will undergo dental procedures (pulpotomy or indirect pulp cap) in an operating room setting. The study will then track the success of these treatments for four years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for four years to assess the clinical and radiographic success of the dental treatments.

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NCT04863222

Clinical and Radiographic Success of MTA vs Biodentine

Recruiting
PHASE4Ages 2–12InterventionalTreatment
Geisinger Clinic
~646 participants
Updated 2025-12-23 on ClinicalTrials.gov
What's tested:Biodentinemineral trioxide aggregate (MTA)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of clinical success in pulpotomies and indirect pulp caps
Measured over 4 years
+1 more outcome measured

Conditions

Indirect Pulp Cap
Pulpotomy

Explore related trials

Caries

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Gayatri Malik, DMD · PRINCIPAL_INVESTIGATOR · Geisinger Clinic

Who to contact

Gayatri Malik, DMD
[email protected]
570-271-6355
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Rate of clinical success in pulpotomies and indirect pulp caps4 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.

  • Rate of radiographic success in pulpotomies and indirect pulp caps4 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.