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

NCT ID: NCT00802256

Last Updated: 2009-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pulpotomy Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

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

Group Type EXPERIMENTAL

pulpotomy

Intervention Type PROCEDURE

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

B

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

Group Type EXPERIMENTAL

pulpotomy

Intervention Type PROCEDURE

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

Interventions

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pulpotomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Iranian center for endodontic research

UNKNOWN

Sponsor Role collaborator

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Shaheed Beheshti University of Medical Sciences

Principal Investigators

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Fatemeh Shekarchi, student

Role: PRINCIPAL_INVESTIGATOR

Saheed Behesti University for Medical sciences

Locations

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Saheed Behesti University for Medical sciences

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Fatemeh Shekarchi, student

Role: CONTACT

00989124849179

Facility Contacts

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Fatemeh Shekarchi, student

Role: primary

00989124849179

Other Identifiers

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63sh138

Identifier Type: -

Identifier Source: org_study_id

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