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

This study is currently recruiting participants.
Verified August 2012 by National Taiwan University Hospital
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00972556
First received: September 3, 2009
Last updated: August 22, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Dental Caries
Pulpitis
 Drug: Gray Mineral Trioxide Aggregate (GMTA)
Drug: Diluted (20%) Formocresol (DFC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Mineral Trioxide Aggregate and 20% Formocresol in Pulpotomized Human Primary Molars :A Long-Term Follow-Up Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • clinically and radiographically outcomes [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • histological outcome [ Time Frame: when the subjective tooth physically exfoliates from oral cavity ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: September 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GMTA 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

Detailed 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).
  Eligibility

Ages Eligible for Study:   30 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972556

Contacts
Contact: Yuan-Ling Lee, PhD 886-2-23123456 ext 67337 yuanlinglee@ntu.edu.tw
Contact: Hsiao-Hua Chang, MS 886-2-23123456 ext 70251 hhchangpedo@gmail.com

Locations
Taiwan
Department of Dentistry, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10048
Contact: Yuan-Ling Lee, PhD         yuanlinglee@ntu.edu.tw    
Contact: Hsiao-Hua Chang, MS         hhchangpedo@gmail.com    
Principal Investigator: Yuan-Ling Lee, PhD            
Sub-Investigator: Hsiao-Hua Chang, MS            
Sponsors and Collaborators
National Taiwan University Hospital
University of Michigan
Investigators
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
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital, Department of Dentistry
ClinicalTrials.gov Identifier: NCT00972556     History of Changes
Other Study ID Numbers: 200905028R
Study First Received: September 3, 2009
Last Updated: August 22, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Mineral Trioxide Aggregate
Formocresol
pulpotomy
primary molar
treatment outcome

Additional relevant MeSH terms:
Dental Caries
Pulpitis
Tooth Demineralization
 Tooth Diseases
Stomatognathic Diseases
Dental Pulp Diseases

ClinicalTrials.gov processed this record on May 19, 2013