Comparing MTA and Biodentine for treating children's teeth
Clinical and Radiographic Success of Mineral Trioxide Aggregate (MTA) vs Septodont Biodentine in Primary Molars in Pulpotomy and Indirect Pulp Cap Treatments
This study is testing whether two different treatments for children's tooth issues, MTA and Biodentine, work better for saving baby teeth in kids aged 2 to 12.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 646 (estimated) |
| Ages | 2 Years to 12 Years |
| Sex | All |
| Sponsor | Geisinger Clinic Academic / other |
| Locations | 1 site (Danville, Pennsylvania) |
| Trial ID | NCT04863222 on ClinicalTrials.gov |
What this trial studies
This prospective interventional study aims to evaluate the clinical and radiographic success of two medicaments, mineral trioxide aggregate (MTA) and Biodentine, in vital pulp therapy for primary molars in children aged 2 to 12. The study employs a randomized split-mouth design, where each child will receive one treatment on one side of their mouth and the other treatment on the opposite side. Participants will be monitored for clinical and radiographic outcomes every six months for three years following the procedures. The research is conducted in accordance with the standards set by the American Academy of Pediatric Dentistry at Geisinger Medical Center and Geisinger Bloomsburg Hospital.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 12 with bilateral symptomatic or asymptomatic vital primary molars requiring pulpotomy or indirect pulp cap treatments.
Not a fit: Patients with irreversible pulpitis, necrotic pulp, or non-restorable molars will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more cost-effective and less discoloring alternative to MTA for vital pulp therapy in children.
How similar studies have performed: While there is limited research on Biodentine, the study's approach of comparing it with MTA in pediatric dental care is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Danville, Pennsylvania
- Geisinger — Danville, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Gayatri Malik, DMD — Geisinger Clinic
- Study coordinator: Gayatri Malik, DMD
- Email: gmalik1@geisinger.edu
- Phone: 570-271-6355
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.