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

NCT ID: NCT01962077

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2021-06-30

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.

Conditions

Pulpotomies Primary Teeth; Effectiveness of MedCem MTA® in Pulpotomies Primary Teeth

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MedCem MTA pulpotomies

Group Type: EXPERIMENTAL

MedCem MTA pulpotomies in primary teeth.

Intervention Type: PROCEDURE

Interventions

MedCem MTA pulpotomies in primary teeth.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

Other Identifiers

Nathalie- HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id