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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. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Iranian center for endodontic research
Information provided by:
Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00802256
First received: December 3, 2008
Last updated: April 9, 2009
Last verified: April 2009
December 3, 2008
April 9, 2009
October 2008
December 2008   (Final data collection date for primary outcome measure)
Clinical features and radiographic examination [ Time Frame: 6 monthes and one year ]
Same as current
Complete list of historical versions of study NCT00802256 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Comparative Evaluation of Pulpotomized Primary Molars With Mineral Trioxide Aggregate and New Endodonthic Cement
Comparative Evaluation of Pulpotomized Primary Molars With Mineralized Trioxide Aggregate & New Endodonthic Cement
A new Endodontic Cement (NEC) is being compared with mineral trioxide aggregate in pulpotomy of primary molars.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulpotomy Treatment
Procedure: pulpotomy
removal of caries and cronal pulp tissue and then restoring of tooth
  • Experimental: A
    teeth which are treated with Mineral Trioxide Aggregate (MTA) material
    Intervention: Procedure: pulpotomy
  • Experimental: B
    teeth which are treated with new Endodontic Cement (NEC) material
    Intervention: Procedure: pulpotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
80
December 2009
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
4 Years to 8 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT00802256
63sh138
Yes
Not Provided
Not Provided
Fatemeh Shekarchi, Shaheed Beheshti University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Iranian center for endodontic research
Principal Investigator: Fatemeh Shekarchi, student Saheed Behesti University for Medical sciences
Shahid Beheshti University of Medical Sciences
April 2009

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