Comparison of Mineral Trioxide Aggregate (MTA) and 20% Formocresol (FC) in Pulpotomized Human Primary Molars
|ClinicalTrials.gov Identifier: NCT00972556|
Recruitment Status : Unknown
Verified August 2012 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : September 7, 2009
Last Update Posted : August 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries Pulpitis||Drug: Gray Mineral Trioxide Aggregate (GMTA) Drug: Diluted (20%) Formocresol (DFC)||Not Applicable|
- 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.
- 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.
The primary aims of this investigation are:
- 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.
- 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:
- Assess the outcome of GMTA by multiple operators that have been calibrated to the methods of mixing and placing the material.
- Assess whether sex, tooth type, arch, and age of patient at time of treatment influence the overall success rate of GMTA pulpotomies.
- 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.
- 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Comparison of Mineral Trioxide Aggregate and 20% Formocresol in Pulpotomized Human Primary Molars :A Long-Term Follow-Up Study|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||July 2014|
Drug: Gray Mineral Trioxide Aggregate (GMTA)
Once hemorrhage from the pulp chamber is under control using direct pressure of a sterile cotton pellet, pulp stumps are covered with a MTA paste, obtained by mixing 0.2g GMTA powder with sterile water in a powder to liquid ratio of 3:1 in weight. The GMTA will be then immediately covered with a zinc-oxide eugenol base (IRM) material.
Other Name: ProRoot MTA
|Active Comparator: 20% FC||
Drug: Diluted (20%) Formocresol (DFC)
After the pulp hemostasis is achieved with direct pressure of a sterile cotton pellet, a sterile cotton pellet dampened with 20% DFC will be placed in contact with the pulp for 5 minutes, followed by the immediate placement of a zinc-oxide eugenol base (IRM) material.
Other Name: Buckley's Formo Cresol
- clinically and radiographically outcomes [ Time Frame: 6, 12, 18, and 24 months ]
- histological outcome [ Time Frame: when the subjective tooth physically exfoliates from oral cavity ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972556
|Contact: Yuan-Ling Lee, PhD||886-2-23123456 ext firstname.lastname@example.org|
|Contact: Hsiao-Hua Chang, MS||886-2-23123456 ext email@example.com|
|Department of Dentistry, National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 10048|
|Contact: Yuan-Ling Lee, PhD firstname.lastname@example.org|
|Contact: Hsiao-Hua Chang, MS email@example.com|
|Principal Investigator: Yuan-Ling Lee, PhD|
|Sub-Investigator: Hsiao-Hua Chang, MS|
|Principal Investigator:||Yuan-Ling Lee, PhD||Department of Dentistry, National Taiwan University Hospital|
|Study Chair:||Hsiao-Hua Chang, MS||Department of Dentistry, National Taiwan University Hospital|