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

Phase 3

• Conditions: Pulpotomy Treatment
• Interventions: Procedure: pulpotomy

• Registration Number: NCT00802256
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2008-12
• Study First Submitted: 2008-12-03
• Study First Submitted QC: 2008-12-03
• Study First Posted: 2008-12-04
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-09
• Last Update Posted: 2009-04-10
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	pulpotomy	teeth which are treated with new Endodontic Cement (NEC) material
A	pulpotomy	teeth which are treated with Mineral Trioxide Aggregate (MTA) material

Primary Outcome Measures

Name	Time	Method
Clinical features and radiographic examination	6 monthes and one year

Trial Locations

Locations (1)

Saheed Behesti University for Medical sciences; 🇮🇷 Tehran, Iran, Islamic Republic of