Recruiting PHASE4 Indirect Pulp Cap

Compares treatment options for Indirect Pulp Cap

Official title Clinical and Radiographic Success of MTA vs Biodentine

ClinicalTrials.gov ID: NCT04863222

What this study is testing

What is mineral trioxide aggregate (MTA)?

mineral trioxide aggregate (MTA) is an investigational medicine, being studied as a potential treatment for indirect pulp cap.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 2 to 12. Healthy volunteers may be eligible.

You may be able to join 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 likely can't join 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Danville, Pennsylvania, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 2 years to 12 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Danville, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.