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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02437708 |
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Date of registration:
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04/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Regenerative Endodontic Procedure of Immature Permanent Teeth With L-PRF: a Pilot Controlled, Clinical Trial
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Scientific title:
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Regenerative Endodontic Procedure of Immature Permanent Teeth With the Use of Autologous L-PRF: a Pilot Controlled, Clinical Trial |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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29 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02437708 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Paul Lambrechts, Prof, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Belgium |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Provision of Informed Consent
- Permanent immature teeth with weak root canal walls (hopeless prognosis)
- Patients younger than 25 years
Exclusion Criteria:
- - Unlikely to be able to comply with the study procedures, as judged by the
investigator.
- Patients older than 25 years
- Deciduous teeth
- Permanent (immature) teeth that can be treated by a "regular" root canal treatment/
apexification
- Known or suspected current malignancy
- History of chemotherapy within 5 years prior to study
- History of radiation in the head and neck region
- History of other metabolic bone diseases
- A medical history that makes REP unfavorable
- Involvement in the planning and conduct of the study
- Previous enrolment in the present study
Age minimum:
6 Years
Age maximum:
25 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Endodontic Inflammation
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Intervention(s)
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Procedure: REP
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Biological: stem and progenitor cells
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Procedure: REP with L-PRF
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Primary Outcome(s)
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Amount of periapical bone healing, measured on intra-oral bidimensional radiographs.
[Time Frame: 3 years]
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Secondary Outcome(s)
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Amount of root development or maturogenesis,by measuring:
[Time Frame: 3 years]
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Secondary ID(s)
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S56810 (ML10723) B322201421941
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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