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

Effectiveness of MedCem MTA® in Pulpotomies Primary Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962077
• Other study ID #: Nathalie- HMO-CTIL
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: June 2021

Study information

• Verified date: June 2021
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• MedCem MTA pulpotomies in primary teeth.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of MedCem MTA pulpotomy in primary molar	No pain, no swelling or sinus tract, no internal root resorption progressing into the bone, no furcation and/or periapical bond destruction.	Up to 36 months