Clinical trial NCT02137967: Sodium Hypochlorite Pulpotomies in Primary Molars: Comparison With Conventional 20% Formocresol Pulpotomies
Official title: Clinical Evaluation of Sodium Hypochlorite Pulpotomies in Primary Molars: A Long-Term Follow-Up in Comparison With Conventional 20% Formocresol Pulpotomies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Dental Pulp Disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-05-14
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: As Brief summary.

Eligibility criteria: Inclusion Criteria:

* healthy, American Society of Anesthesiologists (ASA) Physical Status classification system class I children
* age between 2.5 and 9 years old
* with one or more primary molars need pulpotomy treatment

Exclusion Criteria:

* children younger than 2.5 or older than 9 years of age

Primary outcomes:
measure: Change of Clinical Findings
timeFrame: At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment
Secondary outcomes:
measure: Change of Radiographic Findings
timeFrame: At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Pediatric dental department, National Taiwan University Hospital
Study officials:
affiliation: Assistant Professor
name: Hsiao-Hua Chang, phD
role: PRINCIPAL_INVESTIGATOR
References: