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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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16 December 2017 |
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Main ID: |
NCT03010345 |
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Date of registration:
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27/12/2016 |
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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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The Use of Self Inflating Tissue Expanders In The Treatment Of Alveolar Cleft
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Scientific title:
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The Use of Self Inflating Tissue Expanders In The Treatment Of Alveolar Cleft |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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8 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03010345 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Galal El Behiry, Phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Medically free patients.
- Patients suffering from alveolar cleft with anterior fistulas.
- Age Between 7 and 13 Years
- Both sexes.
- Patients physically able to tolerate surgical and restorative procedures. Good oral
hygiene.
- Highly motivated patients.
Exclusion Criteria:
- non motivated patients
Age minimum:
7 Years
Age maximum:
13 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cleft of Alveolar Ridge
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Intervention(s)
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Device: Osmed self inflating tissue expanders
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Other: Iliac bone graft
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Primary Outcome(s)
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Primary Outcome : Absence of nasal regurgitation. Binary (Yes/No)
[Time Frame: 21 days]
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Secondary Outcome(s)
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Secondary Outcome : absence of soft tissue Dehiscence and preservation of bone graft volume , volume per cubic meter(Measured by cbct)
[Time Frame: 6 months]
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Secondary ID(s)
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Cairo university kasr el ainy
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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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