This trial is active, not recruiting.

Conditions pulpotomies primary teeth, effectiveness of medcem mta® in pulpotomies primary teeth
Treatment medcem mta pulpotomies in primary teeth.
Sponsor Hadassah Medical Organization
Start date October 2013
End date October 2018
Trial size 60 participants
Trial identifier NCT01962077, Nathalie- HMO-CTIL


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
medcem mta pulpotomies in primary teeth.

Primary Outcomes

Success of MedCem MTA pulpotomy in primary molar
time frame: Up to 36 mon

Eligibility Criteria

Male or female participants from 2 years up to 10 years old.

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.

Additional Information

Official title Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Hadassah Medical Organization.