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Comparative Evaluation of Pulpotomized Primary Molars With Mineral Trioxide Aggregate and New Endodonthic Cement

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ClinicalTrials.gov Identifier: NCT00802256
Recruitment Status : Unknown
Verified April 2009 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : December 4, 2008
Last Update Posted : April 10, 2009
Sponsor:
Collaborator:
Iranian center for endodontic research
Information provided by:
Shahid Beheshti University of Medical Sciences

Brief Summary:
A new Endodontic Cement (NEC) is being compared with mineral trioxide aggregate in pulpotomy of primary molars.

Condition or disease Intervention/treatment Phase
Pulpotomy Treatment Procedure: pulpotomy Phase 3

Detailed Description:
Forty patient are selected randomly. Each patient has at least 2 teeth which require pulpotomy treatment. After removing of carious teeth by a low speed round bur and pulp exposure, roof of pulp chamber is removed completely by a high speed 008 fissure bur. Life tissues of pulp are removed by sharp excavator and rinsing with normal salin. Hemostat is achieved and cavity will be cleaned by 0.5% hypo chlorate solution. MTA or NEC material is mixed according to manufacturer instruction and will be placed in pulp chamber and over pulpal canal orifices for at least 1 mm. The light cure glass inomor is also mixed according to manufacturer instruction and is places over the A or B material and cured for 40 minutes. The treated tooth will be restored with a stainless steel crown or amalgam filling material.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Evaluation of Pulpotomized Primary Molars With Mineralized Trioxide Aggregate & New Endodonthic Cement
Study Start Date : October 2008
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
teeth which are treated with Mineral Trioxide Aggregate (MTA) material
Procedure: pulpotomy
removal of caries and cronal pulp tissue and then restoring of tooth
Experimental: B
teeth which are treated with new Endodontic Cement (NEC) material
Procedure: pulpotomy
removal of caries and cronal pulp tissue and then restoring of tooth



Primary Outcome Measures :
  1. Clinical features and radiographic examination [ Time Frame: 6 monthes and one year ]


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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Vital pulp exposure of teeth with caries or trauma
  • No clinical signs & symptoms like pain,inflammation
  • No radiographic signs & symptoms like: internal resorption,external resorption, furcation involvement,pulp canal obliteration.
  • The restorable tooth
  • No dental treatment contraindication

Exclusion Criteria:

  • Systemic diseases
  • Existence of pain,inflammation or sinus tract
  • No patient compliance

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): NCT00802256


Contacts
Contact: Fatemeh Shekarchi, student 00989124849179 fshekarchi84@yahoo.com

Locations
Iran, Islamic Republic of
Saheed Behesti University for Medical sciences Recruiting
Tehran, Iran, Islamic Republic of
Contact: Fatemeh Shekarchi, student    00989124849179    fshekarchi84@yahoo.com   
Principal Investigator: Dr. Saeed Asgary, professor         
Principal Investigator: Dr. Beheshteh Malekafzali, professor         
Principal Investigator: Fatemeh Shekarchi, student         
Sub-Investigator: Dr. Mahdiyeh Beheshti, MD         
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Iranian center for endodontic research
Investigators
Principal Investigator: Fatemeh Shekarchi, student Saheed Behesti University for Medical sciences

Responsible Party: Fatemeh Shekarchi, Shaheed Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00802256     History of Changes
Other Study ID Numbers: 63sh138
First Posted: December 4, 2008    Key Record Dates
Last Update Posted: April 10, 2009
Last Verified: April 2009

Keywords provided by Shahid Beheshti University of Medical Sciences:
pulpotomy
primary molar teeth
MTA
NEC
CEM
Primary Molar Teeth Which Require Pulpotomy Treatment