RecruitingPhase 4

Clinical and Radiographic Success of MTA vs Biodentine

United States646 participantsStarted 2021-11-12

Plain-language 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.

Who can participate

Age range2 Years – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Rate of clinical success in pulpotomies and indirect pulp caps

Timeframe: 4 years

Rate of radiographic success in pulpotomies and indirect pulp caps

Timeframe: 4 years

Trial details

NCT IDNCT04863222

SponsorGeisinger Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-01

Contact for this trial

Gayatri Malik, DMD

570-271-6355 gmalik1@geisinger.edu