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Trial record 12 of 386 for:    FERRIC CATION

Comparison of Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02783911
Recruitment Status : Terminated (The resident graduated.)
First Posted : May 26, 2016
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Jung-Wei Chen, DDS, MS, PhD, Loma Linda University

Tracking Information
First Submitted Date  ICMJE May 18, 2016
First Posted Date  ICMJE May 26, 2016
Last Update Posted Date November 6, 2019
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date November 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
Comparison of the clinical and radiographic success between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) pulpotomies in primary molars [ Time Frame: 1 year ]
At recall visits 6,9,12 months, blinded clinical examination will be completed by participating faculty members who are calibrated to clinical scaring criteria. Periapical radiographs will be taken and evaluated by 2 pediatric dentists and 1 endodontist, for presence of various pathologies. Scored based on the criteria established by Zurn and Seale 2008. Scores will be transferred to Microsoft Excel. The difference between the two materials will be analyzed using the Mann-Whiteney U test, chi-square test and Fisher's exact test. Intra- and inter-rater agreement will be measured for radiographic assessment using Cohen's kappa test
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02783911 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies
Official Title  ICMJE Comparison of Clinical and Radiographic Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies for Primary Molars
Brief Summary Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and Ferric Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9 months and 12 months.
Detailed Description Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and Ferric Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9 months and 12 months. Regular recall and follow up will be performed for patients who has MTA or FS pulpotomies. Clinical and radiographic findings will be recorded.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Teeth
  • Pulpotomy
Intervention  ICMJE
  • Device: MTA
    Mineral Trioxide Aggregate grey paste
  • Drug: Ferric Sulfate
    Ferric Sulfate paste
    Other Name: FS
Study Arms  ICMJE
  • Experimental: Mineral Trioxide Aggregate
    Subject with pulpotomy treated with MTA MTA paste (< 1gm) will be placed on pulp orifice once for the life of the primary teeth
    Intervention: Device: MTA
  • Experimental: Ferric Sulfate
    Subject with pulpotomy treated with FS FS paste (<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth
    Intervention: Drug: Ferric Sulfate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 4, 2019)
66
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2016)
60
Actual Study Completion Date  ICMJE November 4, 2019
Actual Primary Completion Date November 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA I,II
  • Primary Molars diagnosed with normal or reversible pulpitis with vital carious pulp exposures
  • Teeth that can have hemostasis can be achieved with pressure
  • No clinical symptoms
  • No radiographic signs of internal resorption or external root resorption

Exclusion Criteria:

  • Primary Molars diagnosed with irreversible pulpitis or necrotic pulp
  • Teeth that can not achieve hemostasis
  • Teeth with abscess or fistula
  • Teeth that have radiographic signs of internal resorption or external resorption
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02783911
Other Study ID Numbers  ICMJE 5140262
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jung-Wei Chen, DDS, MS, PhD, Loma Linda University
Study Sponsor  ICMJE Loma Linda University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jung-Wei Chen, DDS,MS,PhD Loma Linda University
PRS Account Loma Linda University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP