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

2019-0994

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.

2021-11-12

2025-01-01

2025-07-01

Recruiting

Early phase I

646

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 646, 'type': 'ESTIMATED'}}

2024-02-08