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

Reversible Pulpitis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02702505
Study type Interventional
Source Texas A & M University Baylor College Of Dentistry
Contact
Status Enrolling by invitation
Phase Phase 4
Start date November 2014
Completion date December 2017
View Details
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