RecruitingPhase 4NCT04863222

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


Sponsor

Geisinger Clinic

Enrollment

646 participants

Start Date

Nov 12, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 2 YearsMax Age: 12 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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.

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Interventions

DEVICEBiodentine

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

BIOLOGICALmineral trioxide aggregate (MTA)

mineral trioxide aggregate (MTA)


Locations(1)

Geisinger

Danville, Pennsylvania, United States

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NCT04863222


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