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Success Rate Evaluation of Miniature Pulpotomy With MTA in Primary Molars

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: NCT02286648
Recruitment Status : Unknown
Verified November 2014 by Hossein Nematollahi, Mashhad University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : November 10, 2014
Last Update Posted : November 10, 2014
Sponsor:
Information provided by (Responsible Party):
Hossein Nematollahi, Mashhad University of Medical Sciences

Brief Summary:
The purpose of this study is to evaluate the clinical and radiographic success rate of Miniature pulpotomy with Mineral Trioxide Aggregate (MTA) in primary molars.

Condition or disease Intervention/treatment Phase
Pulpitis Dental Pulp Disease Tooth Diseases Drug: Formocresol Drug: Mineral Trioxide Aggregate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2014
Estimated Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals
Drug Information available for: Formocresol

Arm Intervention/treatment
Experimental: Mineral Trioxide Aggregate
pulpotomy with MTA
Drug: Mineral Trioxide Aggregate
pulpotomy with MTA

Active Comparator: Formocresol
pulpotomy with FC
Drug: Formocresol
pulpotomy with formocresol




Primary Outcome Measures :
  1. successful outcome of treatment as indicated by clinical signs defined with observation and check list [ Time Frame: up to 12 months ]
    success or failure of treatment defined with observation and check list


Secondary Outcome Measures :
  1. successful outcome of treatment as indicated by radiographic signs defined with observation and check list [ Time Frame: up to 12 months ]
    success or failure of treatment defined with observation and check list



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy people(without any systemic disease)
  • teeth :

    • no clinical or radiographic evidence of pulp degeneration
    • the possibility of proper restoration of the teeth

Exclusion Criteria:

  • teeth :

    • excessive bleeding from the exposure site
    • internal root resorption
    • interradicular and/or periapical bone destruction
    • swelling or sinus tract

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): NCT02286648


Contacts
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Contact: Hossein Nematollahi, associate prof. +989151141688 nematollahih@mums.ac.ir
Contact: Homa Noorollahian, Associate prof. +989155577184 noorollahianh@mums.ac.ir

Locations
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Iran, Islamic Republic of
Mashhad University of Medical Siences Recruiting
Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 9185769516
Contact: Hossein Nematollahi, associate of professor         
Contact: Homa Noorollahian, associate of professor         
Principal Investigator: Hossein Nematollahi, associate of professor         
Mashhad University of Medical Siences Recruiting
Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 9185769516
Contact: Hossein Nematollahi, associate of professor         
Contact: Homa Noorollahian, associate of professor         
Sponsors and Collaborators
Mashhad University of Medical Sciences

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Responsible Party: Hossein Nematollahi, principal investigator, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02286648    
Other Study ID Numbers: 921762
First Posted: November 10, 2014    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014
Keywords provided by Hossein Nematollahi, Mashhad University of Medical Sciences:
clinical signs
child
pulpotomy
Additional relevant MeSH terms:
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Pulpitis
Tooth Diseases
Dental Pulp Diseases
Stomatognathic Diseases