Vital Pulp Treatment for Primary Teeth Decay

Overseen By Vineet Dhar, MDS, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Maryland, Baltimore

Disqualifiers: Irreversible pulpitis, Pulp necrosis, Sickle cell, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

76 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Biodentin and Mineral Trioxide Aggregate for primary teeth decay?

Research shows that both Biodentin and Mineral Trioxide Aggregate (MTA) are effective when used as pulpotomy agents (treatments to remove part of the tooth's pulp) in primary teeth, with studies indicating positive clinical and radiographic outcomes. ^{1 2 3 4 5}

Is Vital Pulp Treatment using Biodentin or Mineral Trioxide Aggregate safe for primary teeth?

Studies show that Biodentin and Mineral Trioxide Aggregate (MTA) are generally safe for use in primary teeth, with high success rates and minimal pain reported in children. Most children experienced no or mild pain, and the materials were well-tolerated. ^{1 2 3 6 7}

How is the treatment with Biodentin and Mineral Trioxide Aggregate for primary teeth decay different from other treatments?

This treatment is unique because it uses materials like Biodentin and Mineral Trioxide Aggregate (MTA) that help regenerate the remaining pulp tissue in primary teeth, which is not a feature of many traditional treatments. These materials have been shown to be effective in preserving the health of the tooth's pulp, making them a promising option for treating tooth decay in children. ^{5 6 8 9 10}

What is the purpose of this trial?

In primary teeth, decay that is near the pulp (tooth nerve)is treated with either a pulpotomy or indirect pulp treatment if the tooth is not going to be extracted A pulpotomy involves removing the top 1/2 of the pulp, placing a medication/material on the pulp, covering the remaining pulp with a cement, and the restoring the tooth. The purpose of this pilot study is to gain preliminary information regarding the success of Biodentine, MTA, and IPT in the treatment of deep decay in children's primary molars.

Eligibility Criteria

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

My tooth/teeth are sensitive but can still be treated.

My child has deep cavities in their baby teeth.

Exclusion Criteria

You have teeth that are too damaged and cannot be fixed.

I have severe tooth pain or a tooth infection.

My child cannot have certain dental treatments due to a systemic illness like sickle cell disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either MTA pulpotomy, Biodentine pulpotomy, or indirect pulp treatment for deep decay in primary molars

1-2 weeks

Follow-up

Participants are monitored for clinical and radiographic success of the treatment

3 years

Twice yearly clinical examinations

Treatment Details

Interventions

• Biodentin
• Mineral Trioxide Aggregate

Trial Overview The study tests three treatments on children's teeth: Vitrebond, Mineral Trioxide Aggregate (MTA), and Biodentin. These are used during a pulpotomy or indirect pulp cap to see which is most successful in treating decay near the nerve without extraction.

Participant Groups

Group I: MTA pulpotomy Experimental Treatment 1 Intervention

MTA pulpotomy will be performed for this group

Group II: Indirect pulp cap Experimental Treatment 1 Intervention

IDP will be performed for this group

Group III: Biodentin pulpotomy Experimental Treatment 1 Intervention

Biodentin pulpotomy will be performed for this group

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

References

1. India pubmed.ncbi.nlm.nih.gov

Clinical and Radiographic Evaluation of Success of Two commercially Available Pulpotomy Agents in Primary Teeth: An in vivo Study. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Clinical and radiographic evaluation of indirect pulp treatment with MTA and calcium hydroxide in primary teeth (in-vivo study). [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Tailored 70S30C Bioactive glass induces severe inflammation as pulpotomy agent in primary teeth: an interim analysis of a randomised controlled trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Clinical long-term evaluation of MTA as a direct pulp capping material in primary teeth. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Dentin bridge formation after mineral trioxide aggregate (MTA) pulpotomies in primary teeth. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Evaluation and comparison of mineral trioxide aggregate and biodentine in primary tooth pulpotomy: Clinical and radiographic study. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Biodentine in Pulpotomies of Primary Teeth with Different Stages of Root Resorption Using a Novel Composite Outcome Score. [2021]

8. India pubmed.ncbi.nlm.nih.gov

Success Rate of MTA Pulpotomy on Vital Pulp of Primary Molars: A 3-Year Observational Study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Biodentine and Mineral Trioxide Aggregate in Primary Molar Pulpotomies-A Systematic Review and Meta-Analysis With Trial Sequential Analysis of Randomized Clinical Trials. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Short-term treatment outcome of pulpotomies in primary molars using mineral trioxide aggregate and Biodentine: a randomized clinical trial. [2022]