Clinical and Radiographic Success of MTA vs Biodentine

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulpotomy; Indirect Pulp Cap
• Intervention / Treatment: Device: Biodentine; Biological: mineral trioxide aggregate (MTA)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 646
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Gayatri Malik, DMD; Phone Number: 570-271-6355; Email: gmalik1@geisinger.edu
• Study Contact Backup: Name: Samantha R Crissinger; Phone Number: 570-271-7499; Email: srcrissinger@geisinger.edu

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Recruiting
      • Geisinger
      • Contact: Gayatri Malik, DMD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Biodentine; During a patients procedure, one tooth will receive Biodentine instead of MTA.; Biological: mineral trioxide aggregate (MTA); mineral trioxide aggregate (MTA)
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.	Device: Biodentine; During a patients procedure, one tooth will receive Biodentine instead of MTA.; Biological: mineral trioxide aggregate (MTA); mineral trioxide aggregate (MTA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Investigators: Principal Investigator: Gayatri Malik, DMD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: mineral trioxide aggregate
• Other Study ID Numbers: 2019-0994

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No