Vital Pulp Treatment in Primary Teeth

  • STATUS
    Recruiting
  • days left to enroll
    57
  • participants needed
    156
  • sponsor
    University of Maryland, Baltimore
Updated on 25 March 2022
Accepts healthy volunteers

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.

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.

Details
Condition Vital Pulp Therapies, Indirect Pulp Cap, Pulpotomy
Treatment Mineral Trioxide Aggregate, Biodentin, Vitrebond
Clinical Study IdentifierNCT02298504
SponsorUniversity of Maryland, Baltimore
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Pediatric patients with deep dental decay in primary molars
Teeth with signs and symptoms of reversible pulpitis

Exclusion Criteria

Teeth with clinical symptoms of irriversible pulpitis or pulp necrosis or acute dental infection
Children with systemic illness that contraindicated vital pulp treatment such a sickle cell disease
Teeth that are not restorable
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