Clinical and Radiographic Success of MTA vs Biodentine
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-12
SponsorGeisinger Clinic
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Biodentine
DeviceDuring a patients procedure, one tooth will receive Biodentine instead of MTA.
mineral trioxide aggregate (MTA)
Biological/Vaccinemineral trioxide aggregate (MTA)
Treatment groups
646 Participants
are divided into 2 treatment groupsGroup A: MTA, then BiodentineExperimental treatment 2 interventions
Group B: Biodentine, then MTAExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Rate of clinical success in pulpotomies and indirect pulp caps
To compare the rate of clinical success in primary molars using MTA versus Biodentine in pulpotomies and indirect pulp caps. Subjects will been seen at follow-up standard of care visits every 6 months for 3 years to clinically evaluate if the treatment was successful, if any discoloration has occurred and assess for any signs or symptoms of an abscess.
Time frame
4 years2
Rate of radiographic success in pulpotomies and indirect pulp caps
To compare the rate of radiographic success in primary molars using MTA versus Biodentine in pulpotomies and indirect pulp caps. Subjects will been seen at follow-up standard of care visits every 6 months for 3 years where x-rays will be taken to determine if any abscess have formed.
Time frame
4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov