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This prospective clinical randomized controlled trial is established to compare the clinical, radiographic, and histological treatment outcomes between MTA and FC in pulpotomized human primary molars at 6, 12, 18, 24 month post-treatment and to test the hypothesis that Gray Mineral Trioxide Aggregate (GMTA) is a viable alternative to Diluted (20%) Formocresol (DFC) in pulpotomies treatment of human primary molars.
1. Background: Formocresol (FC) is the most widely used pulpotomy medicament in the primary dentition. There are concerns associated with this medicament, primarily the carcinogenicity of the chemical and internal resorption of the treated tooth. Recently, Mineral Trioxide Aggregate (MTA) has been suggested with preliminary studies showing promising results.
2. Study design: This is a prospective clinical randomized controlled trial (RCT), which will be performed at Department of Dentistry, National Taiwan University Hospital, to compare the treatment outcomes between MTA and FC in pulpotomized human primary molars and to evaluate whether GMTA is a viable alternative to DFC in pulpotomies treatment of human primary molars.
- Null Hypotheses: there is no clinical, radiographic, or histological difference between GMTA and DFC at 6, 12, 18, 24 month post-treatment when used as a pulp dressing agent in pulpotomized primary molars.
- Alternative Hypotheses: There is a statistically significant difference between GMTA and DFC as a pulpotomy agent. GMTA shows clinical and/or radiographic and/or histological success as a dressing material following pulpotomy in primary human molars and may be a suitable replacement for DFC in primary molar pulpotomy.
4. Specific Aims:
- The primary aims of this investigation are:
1. Compare the clinical and radiographic results of GMTA with DFC pulpotomies on vital human primary molars at 6, 12, 18, and 24 months post-operatively.
2. Assess intraradicular histological changes of the pulpal tissue and root dentin following pulpotomy treatment with GMTA or DFC.
- The secondary aims of this investigation are:
1. Assess the outcome of GMTA by multiple operators that have been calibrated to the methods of mixing and placing the material.
2. Assess whether sex, tooth type, arch, and age of patient at time of treatment influence the overall success rate of GMTA pulpotomies.
3. Compare the radiographic success of the two materials based on both the traditional radiographic assessment criteria adopted by the American Academy of Pediatric Dentistry (AAPD) and the alternative radiographic success criteria adopted by Zurn et al. 2000.
4. To serve as a basis for future research in the comparison of GMTA and DFC pulpotomies. This will include larger sample size, longer follow-up periods, and a collaborative study with UM group (Prof. Jan C. Hu).
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Gray Mineral Trioxide Aggregate (GMTA), Diluted (20%) Formocresol (DFC)
Department of Dentistry, National Taiwan University Hospital
National Taiwan University Hospital
Published on BioPortfolio: 2014-07-23T21:13:25-0400
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