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NCT02286648 Clinical Trial

Success Rate Evaluation of Miniature Pulpotomy With MTA in Primary Molars

Pulpitis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02286648
Other study ID # 921762
Secondary ID
Status Recruiting
Phase Phase 4
First received April 25, 2014
Last updated November 7, 2014
Start date February 2014

Study information
Verified date November 2014
Source Mashhad University of Medical Sciences
Contact Hossein Nematollahi, associate prof.
Phone +989151141688
Email nematollahih@mums.ac.ir
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical and radiographic success rate of Miniature pulpotomy with Mineral Trioxide Aggregate (MTA) in primary molars.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 4 Years to 7 Years
Eligibility Inclusion Criteria:

- healthy people(without any systemic disease)

- teeth :

- no clinical or radiographic evidence of pulp degeneration

- the possibility of proper restoration of the teeth

Exclusion Criteria:

- teeth :

- excessive bleeding from the exposure site

- internal root resorption

- interradicular and/or periapical bone destruction

- swelling or sinus tract

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Formocresol
pulpotomy with formocresol
• Mineral Trioxide Aggregate
pulpotomy with MTA

Locations
Country Name City State
Iran, Islamic Republic of Mashhad University of Medical Siences Mashhad Khorasan Razavi
Iran, Islamic Republic of Mashhad University of Medical Siences Mashhad Khorasan Razavi

Sponsors (1)
Lead Sponsor Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary successful outcome of treatment as indicated by clinical signs defined with observation and check list success or failure of treatment defined with observation and check list up to 12 months No
Secondary successful outcome of treatment as indicated by radiographic signs defined with observation and check list success or failure of treatment defined with observation and check list up to 12 months No
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