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:
Hadassah Medical Organization
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 30, 2012 | ||||
| Last Updated Date | July 31, 2012 | ||||
| Start Date ICMJE | August 2012 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Success of the primary molar pulpotomy [ Time Frame: One year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01655342 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessment of the Effectiveness of Biodentine® in Pulpotomies Primary Teeth | ||||
| Official Title ICMJE | Assessment of the Effectiveness of Biodentine® in Pulpotomies Primary Teeth. | ||||
| Brief Summary | Clinical and radiographic assessment of Biodentine® as a pulp dressing material for pulpotomy treatment in human primary molars. |
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| Detailed Description | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Biospecimen | |||||
| Sampling Method | Probability Sample | ||||
| Study Population | Healthy children attending the Pediatric Dentistry Clinic of the Hebrew University-Hadassah School of Dental Medicine in Jerusalem |
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| Condition ICMJE | Effectiveness of Biodentine® in Pulpotomies Primary Teeth | ||||
| Intervention ICMJE | |||||
| Study Group/Cohort (s) | formocresol | ||||
| Publications * | Laurent P, Camps J, About I. Biodentine(TM) induces TGF-β1 release from human pulp cells and early dental pulp mineralization. Int Endod J. 2012 May;45(5):439-48. doi: 10.1111/j.1365-2591.2011.01995.x. Epub 2011 Dec 22. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 3 Years to 12 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01655342 | ||||
| Other Study ID Numbers ICMJE | Moran- HMO-CTIL | ||||
| Has Data Monitoring Committee | |||||
| Responsible Party | Hadassah Medical Organization | ||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE | |||||
| Information Provided By | Hadassah Medical Organization | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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