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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Shaheed Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Iranian center for endodontic research
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00802256
First received: December 3, 2008
Last updated: April 9, 2009
Last verified: April 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Pulpotomy Treatment
 Procedure: pulpotomy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Evaluation of Pulpotomized Primary Molars With Mineralized Trioxide Aggregate & New Endodonthic Cement

Resource links provided by NLM:

MedlinePlus related topics: Minerals
U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:
  • Clinical features and radiographic examination [ Time Frame: 6 monthes and one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: October 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: pulpotomy
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
Other Name: pulpotomy

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.

  Eligibility

Ages Eligible for Study:   4 Years to 8 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Shaheed Beheshti Medical University
Iranian center for endodontic research
Investigators
Principal Investigator: Fatemeh Shekarchi, student Saheed Behesti University for Medical sciences
  More Information

No publications provided

Responsible Party: Fatemeh Shekarchi, Shaheed Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00802256     History of Changes
Other Study ID Numbers: 63sh138
Study First Received: December 3, 2008
Last Updated: April 9, 2009
Health Authority: Iran: Ethics Committee

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

ClinicalTrials.gov processed this record on June 18, 2013