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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
A new formulation of MTA was developed in which bismuth oxide was omitted
Control group
Texas A & M University Baylor College of Dentistry
Dallas, Texas, United States
Color stability
Dental intraoral photographs will evaluated
Time frame: 2 years
Internal resorption
Dental radiographs will be evaluatedresorption
Time frame: 2 years
external resorption
Dental radiographs will be evaluated resorption
Time frame: 2 years
Bone loss
Dental radiographs will be evaluated for intraradicular or periapical bone loss
Time frame: 2 years
Widening of periodontal ligament space
Dental radiographs will be evaluated for widening of the PDL space
Time frame: 2 years
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