Vital Pulp Treatment in Primary Teeth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2026-12-01

Brief Summary

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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.

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Detailed Description

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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

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Vital Pulp Therapies Indirect Pulp Cap Pulpotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Indirect pulp cap

IDP will be performed for this group

Group Type EXPERIMENTAL

Vitrebond

Intervention Type DEVICE

Vital pulp therapy

MTA pulpotomy

MTA pulpotomy will be performed for this group

Group Type EXPERIMENTAL

Mineral Trioxide Aggregate

Intervention Type DRUG

Vital pulp therapy

Biodentin pulpotomy

Biodentin pulpotomy will be performed for this group

Group Type EXPERIMENTAL

Biodentin

Intervention Type DRUG

Vital pulp therapy

Interventions

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Mineral Trioxide Aggregate

Vital pulp therapy

Intervention Type DRUG

Biodentin

Vital pulp therapy

Intervention Type DRUG

Vitrebond

Vital pulp therapy

Intervention Type DEVICE

Other Intervention Names

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MTA pulpotomy Biodentin Pulpotomy Indirect pulp cap

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes