Vital Pulp Treatment in Primary Teeth

University of Maryland Baltimore (UMB)

Status and phase: Active, not recruiting; Phase 4

Conditions: Indirect Pulp Cap; Vital Pulp Therapies; Pulpotomy

Treatments: Drug: Mineral Trioxide Aggregate; Device: Vitrebond; Drug: Biodentin

Study type: Interventional

Funder types: Other

Identifiers

NCT02298504

HP-00058711

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 2 to 9 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 3 patient groups

Indirect pulp cap

Experimental group

Description:

IDP will be performed for this group

Treatment:

Device: Vitrebond

MTA pulpotomy

Experimental group

Description:

MTA pulpotomy will be performed for this group

Treatment:

Drug: Mineral Trioxide Aggregate

Biodentin pulpotomy

Experimental group

Description:

Biodentin pulpotomy will be performed for this group

Treatment:

Drug: Biodentin