NCT00802256

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2008

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 10, 2009

Status Verified

April 1, 2009

Enrollment Period

2 months

First QC Date

December 3, 2008

Last Update Submit

April 9, 2009

Conditions

Pulpotomy Treatment

Keywords

pulpotomyprimary molar teethMTANECCEMPrimary Molar Teeth Which Require Pulpotomy Treatment

Outcome Measures

Primary Outcomes (1)

  • Clinical features and radiographic examination

    6 monthes and one year

Study Arms (2)

A

EXPERIMENTAL

teeth which are treated with Mineral Trioxide Aggregate (MTA) material

Procedure: pulpotomy

B

EXPERIMENTAL

teeth which are treated with new Endodontic Cement (NEC) material

Procedure: pulpotomy

Interventions

pulpotomyPROCEDURE

removal of caries and cronal pulp tissue and then restoring of tooth

AB

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saheed Behesti University for Medical sciences

Tehran, Iran

RECRUITING

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

EndodonticsDentistry

Study Officials

  • Fatemeh Shekarchi, student

    Saheed Behesti University for Medical sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatemeh Shekarchi, student

CONTACT

00989124849179fshekarchi84@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 3, 2008

First Posted

December 4, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2009

Last Updated

April 10, 2009

Record last verified: 2009-04

Locations

IR(1)