NCT02702505

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Texas A & M University Baylor College Of Dentistry · Academic / Other
• Sex: All
• Age: 2 Years – 8 Years
• Healthy volunteers: Accepted

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.

Conditions

• Reversible Pulpitis
• Dental Pulp Diseases

Interventions

Type	Name	Description
BIOLOGICAL	NeoMTA	A new formulation of MTA was developed in which bismuth oxide was omitted
OTHER	ProRoot MTA	Control group

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-03-08
• Last updated: 2016-03-08

Locations

1 site across 1 country: United States