NCT02137967.

Trial name or title	Sodium Hypochlorite Pulpotomies in Primary Molars: Comparison With Conventional 20% Formocresol Pulpotomies
Methods	Formocresol is the most universally taught and most widely used pulpotomy medicament in the primary teeth. However, concerns have been raised over the use of formocresol because of its toxicity and potential carcinogenicity. A substitute for formocresol 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 randomised clinical trial, which will be performed in Paediatric Dentistry Department of the National Taiwan University Hospital, to compare the treatment outcomes between NaOCl and formocresol in human primary molars needing pulpotomy treatment. The aim of this study is to determining whether NaOCl is a suitable replacement for formocresol in the pulpotomy of human primary molar teeth. To assess this aim, 200 healthy children aged from 2.5 to 9 years, who have at least one primary first or second molars diagnosed to receive pulpotomy treatment will be recruited. The involved teeth will be randomly assigned to the control group (dilute 20% formocresol (DFC)) or experimental group (2.5% NaOCl). At three, six, nine, 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 analysed using Chi² test, Fisher's exact test, and t‐test, using a statistical significance at P < 0.05.
Participants	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 30 months to 9 years (child) Exclusion criteria Children younger than 2.5 or older than 9 years of age
Interventions	Experimental: NaOCl pulpotomy Use 2.5% NaOCl as pulpotomy medication. Interventions: procedure: NaOCl pulpotomy drug: 2.5% NaOCl Active comparator: formocresol pulpotomy. Use 20% Formocresol as pulpotomy medicament. Interventions: procedure: formocresol pulpotomy. Drug: 20% Formocresol
Outcomes	Primary: change of clinical findings (time frame: at three, six, nine, 12, 15, 18, 21 and 24 months post‐treatment). The outcome will be assessed first by clinical findings. We can discriminate the result are successful or not by scoring the clinical finding from 1 to 4. Criteria for clinical scoring asymptomatic, clinical score = 1 Slight discomfort: percussion sensitivity; mobility ＞ 1 mm but ＜ 2 mm, clinical score = 2 Minor discomfort: long‐lasting chewing sensitivity; gingival swelling; periodontal pocket formation without exudate; mobility＞ 2 mm but ＜ 3 mm, clinical score = 3 major discomfort: Late pathological changes; spontaneous pain; periodontal pocket formation with exudate; sinus tract; mobility ≧ 3 mm; premature tooth loss due to pathology, clinical score = 4 Secondary: change of radiographic findings (time frame: at three, six, nine, 12, 15, 18, 21 and 24 months post‐treatment). The outcome will be assessed then by radiographic findings. We can discriminate the result are successful or not by scoring the radiographic findings from1 to 5. Criteria for radiographic scoring Dentinal bridge, clinical score = 1, regeneration tissue response No change, clinical score = 2, no pathological changes Pulp canal obliteration, clinical score = 3, slight pathological changes, no clinical significance Periodontal ligament widening, clinical score = 3, slight pathological changes, no clinical significance Internal root resorption (non‐perforated), clinical score = 4, minor pathological changes External root resorption, clinical score = 4, minor pathological changes Internal root resorption (perforated), clinical score = 4, minor pathological changes Peri‐radicular lesion, clinical score = 5, major pathological changes, treatment needed
Starting date	August 2011
Contact information	Hsiao‐Hua Chang, PhD
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