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

Texas A & M University Baylor College Of Dentistry

Status and phase: Unknown; Phase 4

Conditions: Dental Pulp Diseases; Reversible Pulpitis

Treatments: Biological: NeoMTA; Other: ProRoot MTA

Study type: Interventional

Funder types: Other

Identifiers

NCT02702505

072015-041

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 2 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

NeoMTA

Experimental group

Description:

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

Treatment:

Biological: NeoMTA

ProRoot MTA

Other group

Description:

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.

Treatment:

Other: ProRoot MTA