NCT02298504

Vital Pulp Treatment in Primary Teeth

Evaluation of MTA Pulpotomy, Biodentine Pulpotomy, and Glass Ionomer Indirect Pulp Treatment in Primary Teeth

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 2 Years – 9 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Pediatric patients having deep decay in primary molars seen at UMMC, UMSOD, and University of Maryland Rehabilitation and Orthopaedic Institute, will be included in the sample. Teeth with deep caries, \>50% into dentin, will be randomly assigned using a table of random numbers to the three treatment groups: Group 1 pulpotomy with MTA, Group 2 pulpotomy with Biodentine, Group 3 indirect pulp treatment. Treatment will be performed by board certified pediatric dentists or they will directly supervise pediatric dental residents at each site as part of their regular protocol for treating deep caries. Radiographs will be taken as prescribed in the Guideline for taking Radiographs in Children by the American Academy of Pediatric Dentistry. Twice yearly clinical examinations will be performed by the treating dentists or pediatric dental residents to check for any soft tissue pathology such as abscess or mobility of treated tooth/teeth. If treatment success/failure consensus between the blinded dentists is not reached, a third dentist will be consulted. The success/failure data will be entered onto spreadsheets and examined statistically using statistical software.

Conditions

• Vital Pulp Therapies
• Indirect Pulp Cap
• Pulpotomy

Interventions

Type	Name	Description
DRUG	Mineral Trioxide Aggregate	Vital pulp therapy
DRUG	Biodentin	Vital pulp therapy
DEVICE	Vitrebond	Vital pulp therapy

Timeline

• Start date: 2018-07-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2014-11-24
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study