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Assessment of the Effectiveness of Biodentine® in Pulpotomies Primary Teeth

This study is not yet open for participant recruitment.
Verified July 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01655342
First received: July 30, 2012
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

Clinical and radiographic assessment of Biodentine® as a pulp dressing material for pulpotomy treatment in human primary molars.


Condition
Effectiveness of Biodentine® in Pulpotomies Primary Teeth

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Effectiveness of Biodentine® in Pulpotomies Primary Teeth.

Resource links provided by NLM:

Drug Information available for: Formocresol
U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Success of the primary molar pulpotomy [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
formocresol

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy children attending the Pediatric Dentistry Clinic of the Hebrew University-Hadassah School of Dental Medicine in Jerusalem

Criteria

Inclusion Criteria:

  • one or more primary teeth which requires pulpotomy.

Exclusion Criteria:

  • not healthy patients,
  • patients with teeth which requires pulpectomy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655342

Contacts
Contact: Moti Moskovitz, DMD, PhD motim@md.huji.ac.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD     00 972 2 6777572     lhadas@hadassah.org.il    
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Publications:

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01655342     History of Changes
Other Study ID Numbers: Moran- HMO-CTIL
Study First Received: July 30, 2012
Last Updated: July 31, 2012
Health Authority: Israel: Ministry of Health - Director General

Keywords provided by Hadassah Medical Organization:
pulpotomy
primary teeth
Biodentine®
formocresol

ClinicalTrials.gov processed this record on May 16, 2013