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Biodentine vs MTA for Dental Cavities

Phase 4
Recruiting
Led By Gayatri Malik, DMD
Research Sponsored by Geisinger Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patients ages of 2 to ≤12 years
Bilateral symptomatic or asymptomatic vital primary molars with caries approximating or into the pulp
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is testing whether a newer, cheaper product called Biodentine is as effective as the current gold standard, MTA, for treating cavities in kids' teeth.

Who is the study for?
This trial is for kids aged 2 to 12 with primary molars needing vital pulp therapy due to cavities close to or reaching the pulp. It's only for those who can get treatment at Geisinger and whose parents consent in English. Kids with irreversible tooth nerve damage, heart conditions requiring infection prevention, cancer history, or non-restorable molars cannot join.Check my eligibility
What is being tested?
The study compares MTA and Biodentine's effectiveness in treating children's molar teeth by assessing clinical outcomes and x-ray results after using these materials for vital pulp therapy. Biodentine could be a cheaper alternative that doesn't stain teeth like MTA.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks of dental procedures may include discomfort, swelling, infection risk at the treated site, allergic reactions to materials used (though rare), and potential failure leading to further dental work.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 2 and 12 years old.
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I have tooth decay in my primary molars that may be affecting the tooth's pulp.
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My child's legal guardian can consent in English.
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I need dental treatments for the inner part of my tooth in two or more areas.
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I need surgery that requires an operating room at Geisinger.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of clinical success in pulpotomies and indirect pulp caps
Rate of radiographic success in pulpotomies and indirect pulp caps

Trial Design

2Treatment groups
Experimental Treatment
Group I: MTA, then BiodentineExperimental Treatment2 Interventions
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.
Group II: Biodentine, then MTAExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biodentine
2013
Completed Phase 4
~1080

Find a Location

Who is running the clinical trial?

Geisinger ClinicLead Sponsor
147 Previous Clinical Trials
1,877,147 Total Patients Enrolled
Gayatri Malik, DMDPrincipal InvestigatorGeisinger Clinic

Media Library

Biodentine Clinical Trial Eligibility Overview. Trial Name: NCT04863222 — Phase 4
Pulpotomy Research Study Groups: Biodentine, then MTA, MTA, then Biodentine
Pulpotomy Clinical Trial 2023: Biodentine Highlights & Side Effects. Trial Name: NCT04863222 — Phase 4
Biodentine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04863222 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned mineral trioxide aggregate (MTA) for therapeutic use?

"The safety of mineral trioxide aggregate (MTA) receives a score of 3, due to being in the final stage of clinical trials and receiving approval for use."

Answered by AI

Are individuals under four decades of age admissible to this medical experiment?

"The study is limited to patients who are 2-12 years of age. For those under 18, there are 5 separate trials that may be suitable and a single trial for individuals over 65 years old."

Answered by AI

Is there a possibility for me to join this experiment?

"This clinical trial demands that participants have previously undergone a pulpotomy procedure, and are aged between 2 to 12 years old. The study is currently open for 646 volunteers."

Answered by AI

How many participants are engaged in this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this medical experiment is still searching for volunteers and was first posted on November 12th 2021 with a recent update also taking place that same day. This trial needs 646 participants from one single location."

Answered by AI

Are there current opportunities to join this research project?

"Affirmative. Reports from clinicaltrials.gov confirm that this experiment is actively looking for subjects, with 646 total participants required across one medical facility. This trial was originally posted on November 12th 2021 and has most recently been revised on the same day."

Answered by AI
~157 spots leftby Jan 2025