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

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.

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