Recruiting

MTA vs. Biodentine

Sponsor:

Geisinger Clinic

Code:

NCT04863222

Conditions

Indirect Pulp Cap

Pulpotomy

Eligibility Criteria

Sex: All

Age: 2 - 12

Healthy Volunteers: Accepted

Interventions

Biodentine

mineral trioxide aggregate (MTA)

Study Details

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.

Conditions

Indirect Pulp Cap

Pulpotomy

Study ID

NCT04863222

Start date

Nov 12, 2021

Status verified date

Dec, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 12

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

646 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

Interventions

Biodentine

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

mineral trioxide aggregate (MTA)

mineral trioxide aggregate (MTA)

Primary outcome measure

  • Rate of clinical success in pulpotomies and indirect pulp caps [ Time Frame: 4 years ]
  • Rate of radiographic success in pulpotomies and indirect pulp caps [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Gayatri Malik, DMD

570-271-6355gmalik1@geisinger.edu

Samantha R Crissinger

570-271-7499srcrissinger@geisinger.edu

Locations

Geisinger

Recruiting

Danville, Pennsylvania, United States, 17822

More Information

Sponsor

Geisinger Clinic

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Geisinger Clinic on 2025-12-23.