Vital Pulp Treatment for Primary Teeth Decay
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of different treatments for deep tooth decay in children's primary molars. The goal is to determine if Biodentine or Mineral Trioxide Aggregate (MTA) treatments succeed when decay is near the tooth's nerve. Children with deep decay in their primary molars, whose tooth nerve shows potential for healing, might be suitable candidates for this trial. The trial compares two types of pulpotomy (partial removal of the tooth nerve) and an indirect pulp treatment (treatment without nerve removal) to identify the most effective approach. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, providing an opportunity to understand their benefits for more patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What is the safety track record for Biodentin and Mineral Trioxide Aggregate?
Research has shown that both Biodentine and Mineral Trioxide Aggregate (MTA) are generally safe and well-tolerated for treating deep cavities in children's baby teeth. Studies have found that Biodentine is effective and safe for use in pulpotomy, a procedure to treat tooth decay, with high success rates over time and few reports of side effects. Participants in these studies experienced little discomfort or complications.
Similarly, studies on MTA pulpotomies have shown positive results. MTA is known for its safety and effectiveness in treating tooth decay near the tooth's center, often outperforming other treatments in terms of safety and success, with very few side effects reported.
Both treatments have undergone thorough testing and are considered very safe, providing reassurance to those considering participation in a clinical trial for these dental procedures.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for primary teeth decay because they utilize innovative materials like Biodentin and Mineral Trioxide Aggregate (MTA). Unlike standard fillings, which simply restore the tooth, Biodentin and MTA promote natural healing by encouraging the formation of new dentin, the tooth’s protective layer. This means they not only fill the cavity but also help the tooth repair itself. Biodentin and MTA have the potential to provide a more holistic approach to dental care by both addressing decay and enhancing the tooth's natural regenerative processes.
What evidence suggests that this trial's treatments could be effective for primary teeth decay?
Research has shown that both Biodentine and mineral trioxide aggregate (MTA) effectively treat deep cavities in children's baby teeth. In this trial, participants will be assigned to different treatment arms: one group will receive a Biodentine pulpotomy, while another will undergo an MTA pulpotomy. Studies indicate that Biodentine can achieve up to 100% success over two years. Similarly, MTA has a success rate of up to 93.5% after two years. Both materials treat decay effectively without damaging the tooth's nerve. This evidence suggests that Biodentine and MTA are reliable choices for treating deep tooth decay in children.26789
Are You a Good Fit for This Trial?
This trial is for children with deep decay in primary molars showing signs of reversible pulpitis. It's not suitable for kids with irreversible pulpitis, pulp necrosis, acute infection, systemic illnesses like sickle cell disease, or if the tooth can't be restored.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either MTA pulpotomy, Biodentine pulpotomy, or indirect pulp treatment for deep decay in primary molars
Follow-up
Participants are monitored for clinical and radiographic success of the treatment
What Are the Treatments Tested in This Trial?
Interventions
- Biodentin
- Mineral Trioxide Aggregate
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor