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

Phase 4

• Conditions: Reversible Pulpitis; Dental Pulp Diseases
• Interventions: Biological: NeoMTA; Other: ProRoot MTA

• Registration Number: NCT02702505
• Lead Sponsor: Texas A & M University Baylor College Of Dentistry

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-11
• Status Verified: 2016-03
• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-07
• Last Update Submitted: 2016-03-07
• Study First Posted: 2016-03-08
• Last Update Posted: 2016-03-08
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NeoMTA	NeoMTA	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
ProRoot MTA	ProRoot MTA	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.

Primary Outcome Measures

Name	Time	Method
Color stability	2 years	Dental intraoral photographs will evaluated
Internal resorption	2 years	Dental radiographs will be evaluatedresorption
Bone loss	2 years	Dental radiographs will be evaluated for intraradicular or periapical bone loss
Widening of periodontal ligament space	2 years	Dental radiographs will be evaluated for widening of the PDL space
external resorption	2 years	Dental radiographs will be evaluated resorption

Trial Locations

Locations (1)

Texas A & M University Baylor College of Dentistry; 🇺🇸 Dallas, Texas, United States