Assessment of the Effectiveness of Biodentine® in Pulpotomies Primary Teeth

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01655342
First received: July 30, 2012
Last updated: September 25, 2013
Last verified: July 2012
  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.

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 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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: September 25, 2013
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 September 18, 2014