An Early Phase 1 interventional study of NaOCl pulpotomy and FC pulpotomy in Dental Pulp Disease, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 30 Months to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-14.
Sponsored by National Taiwan University Hospital · Early Phase 1, Interventional, and Treatment
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.
As Brief summary.
125 studies on the registry are indexed under Dental Pulp Diseases; 38 are open to participants now.
This study's planned enrollment of 200 is above the median of 50 across 103 interventional studies indexed under Dental Pulp Diseases.
Browse Dental Pulp Diseases studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
Use 2.5% NaOCl as pulpotomy medication
Procedure: NaOCl pulpotomy · Drug: 2.5% NaOCl
Use 20% Formocresol as pulpotomy medicament
Procedure: FC pulpotomy · Drug: 20% Formocresol
Use 2.5% NaOCl as pulpotomy medicament for primary molars
Use 20% Formocresol as pulpotomy medicament for primary molars
Change of Clinical Findings
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 1. Asymptomatic, clinical score=1 2. Slight discomfort: percussion sensitivity; mobility\>1mm but\<2mm, clinical score=2 3. Minor discomfort :long-lasting chewing sensitivity; gingival swelling; periodontal pocket formation without exudate; mobility\>2mm but\<3mm, clinical score=3 4. 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
Time frame: At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment
Change of Radiographic Findings
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 1. Dentinal bridge, clinical score=1, regeneration tissue response 2. No change, clinical score=2, no pathological changes 3. Pulp canal obliteration, clinical score=3, slight pathological changes, no clinical significance 4. Periodontal ligament widening, clinical score=3, slight pathological changes, no clinical significance 5. Internal root resorption (non-perforated), clinical score=4, minor pathological changes 6. External root resorption, clinical score=4, minor pathological changes 7. Internal root resorption (perforated), clinical score=4, minor pathological changes 8. Peri-radicular lesion, clinical score=5, major pathological changes, treatment needed
Time frame: At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment
This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital