Sodium Hypochlorite Pulpotomies in Primary Molars: Comparison With Conventional 20% Formocresol Pulpotomies
Status:
Unknown status
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
Formocresol (FC) is the most universally taught and most widely used pulpotomy medicament in
the primary teeth. However, concerns have been raised over the use of FC because of its
toxicity and potential carcinogenicity. A substitution for FC has been investigated but
evidence is lacking to conclude which is the most appropriate technique for pulpotomies in
primary teeth. Sodium hypochlorite (NaOCl) has been used in root canal irrigant for more than
80 years, and it is at present the most popular irrigant in root canal treatment. Studies
have showed that NaOCl is biological compatible and is a very good antimicrobial solution
without being a pulpal irritant. Recent studies using sodium hypochlorite as pulpotomy
medicament in primary molars showed promising results. In this project, the investigators
propose a randomized clinical trial, which will be performed in Pediatric Dentistry
Department of the National Taiwan University Hospital, to compare the treatment outcomes
between NaOCl and FC in human primary molars needing pulpotomy treatment. The aim of this
sudy is to determining weather NaOCl is a suitable replacement for FC in the pulpotomy of
human primary molar teeth. To assess this aim, 200 healthy children from 2.5 to 9 year-old,
who have at least one primary first or second molars diagnosed to receive pulpotomy treatment
will be recruited in this project. The involved teeth will be randomly assigned to the
control group (dilute 20% Formocresol (DFC)) or experimental group (2.5% NaOCl). At 3, 6, 9,
12, 15, 18, 21 and 24 months post-treatment, the randomly assigned teeth will be clinically
and radiographically evaluated by blinded independent evaluators to the treatment group. The
differences will be statistically analyzed using chi-square test, Fisher exact test, and
t-test, using a statistical significance at p<0.05.