Clinical trial NCT00972556: Comparison of Mineral Trioxide Aggregate (MTA) and 20% Formocresol (FC) in Pulpotomized Human Primary Molars
Official title: Comparison of Mineral Trioxide Aggregate and 20% Formocresol in Pulpotomized Human Primary Molars :A Long-Term Follow-Up Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Pulpitis
Keywords: Mineral Trioxide Aggregate
Formocresol
pulpotomy
primary molar
treatment outcome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2009-09-07
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: clinically and radiographically outcomes
timeFrame: 6, 12, 18, and 24 months
Secondary outcomes:
measure: histological outcome
timeFrame: when the subjective tooth physically exfoliates from oral cavity
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Dentistry, National Taiwan University Hospital
Study officials:
affiliation: Department of Dentistry, National Taiwan University Hospital
name: Yuan-Ling Lee, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Dentistry, National Taiwan University Hospital
name: Hsiao-Hua Chang, MS
role: STUDY_CHAIR
References: