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

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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

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.

Condition or disease Intervention/treatment Phase
Primary Teeth Pulpotomy Device: MTA Drug: Ferric Sulfate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Clinical and Radiographic Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies for Primary Molars
Actual Study Start Date : April 2016
Actual Primary Completion Date : November 4, 2019
Actual Study Completion Date : November 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
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
Device: MTA
Mineral Trioxide Aggregate grey paste

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
Drug: Ferric Sulfate
Ferric Sulfate paste
Other Name: FS




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783911


Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Jung-Wei Chen, DDS,MS,PhD Loma Linda University

Publications of Results:
Other Publications:
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Responsible Party: Jung-Wei Chen, DDS, MS, PhD, Pediatric Dental Director, Loma Linda University
ClinicalTrials.gov Identifier: NCT02783911     History of Changes
Other Study ID Numbers: 5140262
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jung-Wei Chen, DDS, MS, PhD, Loma Linda University:
Clinical and Radiograph
Additional relevant MeSH terms:
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Ferric Compounds
Hematinics