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Calcium Silicate-based Material

Vital Pulp Treatment for Primary Teeth Decay

Phase 4

Waitlist Available

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is testing three different ways to treat deep tooth decay in children's primary teeth, to see which is most successful.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects may include discomfort at the treatment site, sensitivity in the treated tooth, and potential failure leading to tooth extraction if the material does not prevent further decay or infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical success after indirect pulp cap

Clinical success after pulpotomy

Radiographic success after pulpotomy

Trial Design

3Treatment groups

Experimental Treatment

Group I: MTA pulpotomyExperimental Treatment1 Intervention

MTA pulpotomy will be performed for this group

Group II: Indirect pulp capExperimental Treatment1 Intervention

IDP will be performed for this group

Group III: Biodentin pulpotomyExperimental Treatment1 Intervention

Biodentin pulpotomy will be performed for this group

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mineral Trioxide Aggregate

2009

Completed Phase 3

~770

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,580 Total Patients Enrolled

Media Library

Biodentin (Calcium Silicate-based Material) Clinical Trial Eligibility Overview. Trial Name: NCT02298504 — Phase 4

Pulpotomy Research Study Groups: Indirect pulp cap, Biodentin pulpotomy, MTA pulpotomy

Pulpotomy Clinical Trial 2023: Biodentin Highlights & Side Effects. Trial Name: NCT02298504 — Phase 4

Biodentin (Calcium Silicate-based Material) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02298504 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial accept new participants?

"Eligible participants for the pulpotomy trial must be aged between 2 and 9. Approximately 156 applicants are being accepted into this research study."

Answered by AI

Is the eligibility for this trial limited to individuals aged 30 or younger?

"As stated in the rules for this experiment, children must be between 2 and 9 years old to meet eligibility requirements."

Answered by AI

Has the Food and Drug Administration certified Biodentin for human use?

"There is a fair amount of evidence confirming Biodentin's safety, thus we gave it the maximum rating on our scale (3). This drug has already been approved for public use."

Answered by AI

Is there still capacity for enrollment in this experimentation?

"Clinicaltrials.gov confirms that, as of January 26th 2022, this clinical trial is seeking participants. Initially posted on July 1st 2018, the study has recently been updated with new data."

Answered by AI

What is the ceiling for patient participation in this research project?

"Correct. The clinical trial database indicates that this medical study is currently accepting participants. It was first made available on July 1st 2018, and the most recent update occured January 26th 2022; 156 people will be studied at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vital Pulp Treatment in Primary Teeth

Vineet Dhar 2018. "Vital Pulp Treatment in Primary Teeth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02298504.