Clinical and Radiographic Success of MTA vs Biodentine

NCT04863222 | Recruiting Phase 4 FDA Device

• 1 other identifier: 2019-0994
• Study Type: interventional
• Target: 646
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Rate of clinical success in pulpotomies and indirect pulp caps

  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.

  4 years

• Rate of radiographic success in pulpotomies and indirect pulp caps

  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.

  4 years

Study Arms (2)

MTA, then Biodentine

EXPERIMENTAL

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.

Device: Biodentine; Biological: mineral trioxide aggregate (MTA)

Biodentine, then MTA

EXPERIMENTAL

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.

Device: Biodentine; Biological: mineral trioxide aggregate (MTA)

Interventions

Biodentine DEVICE

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

Biodentine, then MTA; MTA, then Biodentine

mineral trioxide aggregate (MTA) BIOLOGICAL

mineral trioxide aggregate (MTA)

Biodentine, then MTA; MTA, then Biodentine

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger

Danville, Pennsylvania, 17822, United States

RECRUITING

MeSH Terms

Interventions

mineral trioxide aggregate

Study Officials

• Gayatri Malik, DMD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gayatri Malik, DMD

CONTACT

570-271-6355; gmalik1@geisinger.edu

Samantha R Crissinger

CONTACT

570-271-7499; srcrissinger@geisinger.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: April 28, 2021
• Study Start: November 12, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)