Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 Shahid Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Iranian center for endodontic research
Information provided by:
Shahid Beheshti Medical University
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00802256 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulpotomy Treatment
Procedure: pulpotomy
removal of caries and cronal pulp tissue and then restoring of tooth
Other Name: pulpotomy
  • 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.
 
Recruiting
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
Both
4 Years to 8 Years
Yes
Contact: Fatemeh Shekarchi, student 00989124849179 fshekarchi84@yahoo.com
Iran, Islamic Republic of
 
NCT00802256
63sh138
Yes
Fatemeh Shekarchi, Shaheed Beheshti University of Medical Sciences
Shahid Beheshti Medical University
Iranian center for endodontic research
Principal Investigator: Fatemeh Shekarchi, student Saheed Behesti University for Medical sciences
Shahid Beheshti Medical University
April 2009

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