Success and Color Stability of MTA Pulpotomized Primary Molars: an RCT

Study Overview
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Brief Summary
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Mineral trioxide aggregate has been previously FDA approved as an endodontic filler. Its use in vital teeth has demonstrated significant color change post-treatment leaving it ineffective for esthetic use.. The new formulation will be tested to see if has the same effect.

Detailed Description
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This randomized control, split-mouth trial will use 50 pediatric subjects selected from the patient population in the pediatric dental clinics at Baylor College of Dentistry and in select faculty private practices. The study will use a within-subject control design whereby one tooth will be treated with a pulpotomy using the new formulation of MTA (NeoMTA Plus, Avalon Biomed Inc., Bradenton, FL, USA) and restored with a multi-surface composite, and the other tooth with an MTA pulpotomy and restored with a SSC; thus, approximately 50 teeth will be treated for each treatment group. The restoration type will be randomized as to which side will receive the SSC or composite using sealed, opaque envelopes. Approximately 50 subjects will be needed for the study in order to elicit any significant findings as demonstrated by a power analysis from a similar study.

Official Title
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Success and Color Stability of MTA Pulpotomized Primary Molars: an RCT

Conditions
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Reversible Pulpitis, Dental Pulp Diseases

Intervention / Treatment
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* Biological: NeoMTA
* Other: ProRoot MTA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Children between the ages of 2 ½ and 8 years of age Patient must have two, contralateral primary molars that are matched for type of molar (first or second), size of carious lesion (same level of approximation of carious lesion to the pulp), and arch (maxillary or mandibular) that are treatment planned for a pulpotomy The teeth selected for the study must be vital and asymptomatic both clinically and radiographically or only display symptoms consistent with reversible pulptitis The teeth selected for the study must be anticipated to be retained in the mouth for at least two years Each patient must have an updated medical history form in the dental record, be examined by the operator, and be classified as ASA I or II (in good general health) Exclusion Criteria: Teeth with a history of spontaneous pain Teeth with radiographic evidence of internal or external resorption, intraradicular or periapical bone loss, loss of lamina dura, or widening of the periodontal ligament space

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeoMTA<br>The new formulation of MTA (does not contain bismuth oxide) will be used in one tooth receiving a pulpotomy to determine if the color of the tooth changes over time. The new formulation has received the Food and Drug Administrations 510(k) substantial equivalence clearance for Class II dental materials and is equivalent to its MTA predicate (ProRoot, Dentsply Tulsa Dental, Tulsa, OK, USA).19 | Biological: NeoMTA<br>* A new formulation of MTA was developed in which bismuth oxide was omitted<br>|
| Other: ProRoot MTA<br>Control group. This group will receive the old formulation of MTA in the pulpotomy and the tooth will receive a full coverage stainless steel crown restoration. | Other: ProRoot MTA<br>* Control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Color stability | Dental intraoral photographs will evaluated | 2 years | 
| Internal resorption | Dental radiographs will be evaluatedresorption | 2 years | 
| external resorption | Dental radiographs will be evaluated resorption | 2 years | 
| Bone loss | Dental radiographs will be evaluated for intraradicular or periapical bone loss | 2 years | 
| Widening of periodontal ligament space | Dental radiographs will be evaluated for widening of the PDL space | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulp, pulpotomies, mineral trioxide aggregate