Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth.

Not Applicable

Completed

• Conditions: Pulpotomies Primary Teeth; Effectiveness of MedCem MTA® in Pulpotomies Primary Teeth
• Interventions: Procedure: MedCem MTA pulpotomies in primary teeth.

• Registration Number: NCT01962077
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

assess the effect of MedCem MTA as a pulp medicament following pulpotomy in human primary molars with carious pulp exposure in comparison to Formocresol.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-25
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-10
• Study First Posted: 2013-10-14
• Status Verified: 2021-06
• Primary Completion: 2021-06
• Study Completion: 2021-06
• Last Update Submitted: 2021-07-01
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. healthy children
2. with Asymptomatic primary molars with a deep carious lesion;
3. Exposure of a vital pulp by caries;
4. No clinical or radiographic evidence of pulp degeneration, such as excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction,swelling, or sinus tract;
5. Ability to perform a leakage free restoration of the teeth using stainless steel crown, or amalgam/resin based restoration.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MedCem MTA pulpotomies	MedCem MTA pulpotomies in primary teeth.	-

Primary Outcome Measures

Name	Time	Method
Success of MedCem MTA pulpotomy in primary molar	Up to 36 months	No pain, no swelling or sinus tract, no internal root resorption progressing into the bone, no furcation and/or periapical bond destruction.

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel