Comparison of Mineral Trioxide Aggregate (MTA) and 20% Formocresol (FC) in Pulpotomized Human Primary Molars

Dental Caries Clinical Trial

Official title:

Comparison of Mineral Trioxide Aggregate and 20% Formocresol in Pulpotomized Human Primary Molars :A Long-Term Follow-Up Study

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00972556
• Other study ID #: 200905028R
• Status: Unknown status
• Phase: N/A
• First received: September 3, 2009
• Last updated: August 22, 2012
• Start date: September 2009
• Est. completion date: July 2014

Study information

• Verified date: August 2012
• Source: National Taiwan University Hospital
• Contact: Yuan-Ling Lee, PhD
• Phone: 886-2-23123456
• Email: yuanlinglee[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

3. Hypotheses:

• 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).

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 200
• Est. completion date: July 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Months to 10 Years

Eligibility

Inclusion Criteria:

• Primary first or second molars with normal pulp, reversible, or irreversible pulpitis, that have vital carious pulp exposures due to caries and whose pulp bled upon entering the pulp chamber.

• Teeth in which hemostasis could be achieved with pressure of a saline dampened sterile cotton pellet prior to medicament/material placement.

• No clinical symptoms or evidence of pulp degeneration, such as excessive bleeding from the root canal, history of swelling, mobility, or sinus tracts.

• Patients with percussion sensitivity or spontaneous and persistent pain but where hemostasis could be achieved with pressure of sterile cotton pellet.

• No radiographic signs of internal or external root resorption, inter-radicular and/or periapical bone destruction, or furcation radiolucency.

• No more than one-third physiologic root resorption has occurred.

• Teeth had not previously been pulpally treated.

• Teeth deemed to be restorable with posterior stainless steel crowns.

Exclusion Criteria:

• Not present

Related Conditions & MeSH terms

• Dental Caries
• Pulpitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Department of Dentistry, National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	University of Michigan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinically and radiographically outcomes		6, 12, 18, and 24 months
Secondary	histological outcome		when the subjective tooth physically exfoliates from oral cavity