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

August 22, 2012 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10048
        • Recruiting
        • Department of Dentistry, National Taiwan University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yuan-Ling Lee, PhD
        • Sub-Investigator:
          • Hsiao-Hua Chang, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Buckley's Formo Cresol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinically and radiographically outcomes
Time Frame: 6, 12, 18, and 24 months
6, 12, 18, and 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
histological outcome
Time Frame: when the subjective tooth physically exfoliates from oral cavity
when the subjective tooth physically exfoliates from oral cavity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ANTICIPATED)

July 1, 2013

Study Completion (ANTICIPATED)

July 1, 2014

Study Registration Dates

First Submitted

September 3, 2009

First Submitted That Met QC Criteria

September 4, 2009

First Posted (ESTIMATE)

September 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 23, 2012

Last Update Submitted That Met QC Criteria

August 22, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200905028R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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