Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-03-04 @ 7:21 AM
Study NCT ID:
NCT02702505
Status:
UNKNOWN
Last Update Posted:
2016-03-08
First Post:
2016-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Success and Color Stability of MTA Pulpotomized Primary Molars: an RCT
Sponsor:
Texas A & M University Baylor College Of Dentistry
Organization:
Study Overview
Official Title:
Success and Color Stability of MTA Pulpotomized Primary Molars: an RCT
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MTA
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: