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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: |
NCT03083392 |
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Date of registration:
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05/03/2017 |
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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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Endosseous Oroantral Port for Minimal Intervention in Treating Chronic Sinusitis
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Scientific title:
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Endosseous Oroantral Port for Minimal Intervention in Treating Chronic Sinusitis |
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Date of first enrolment:
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March 2017 |
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Target sample size:
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20 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03083392 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Samer Srouji, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Western Galilee Medical Center |
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Name:
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Sigal Shor |
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Address:
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Telephone:
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+972-4-9107270 |
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Email:
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sigal.shor@naharia.health.gov.il |
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Affiliation:
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Name:
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Ruth Angel-Dar, Dr. |
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Address:
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Telephone:
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+972-4-9107076 |
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Email:
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rutiangel123@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- No medical history of diseases involving bone metabolism
- Unilateral or bilateral maxillary sinusitis, as evident by radiographic and endoscopic
modaleties, which have not responded to optimal conservative treatment
- Patient who is edentulous in the maxillary region and is interested in dental implant
- The patient does not participate in another clinical study
- The patient can read and understand the informed consent
Exclusion Criteria:
- Medical history of increased risk of developing bone necrosis (MRONJ - medically
related osteonecrosis of the jaw , or ORN - osteoradionecrosis)
- patients who are not interested or need dental implants
- Patients with maxillary sinus neoplastic pathology
- Chronic maxillary sinusitis with polyps
- Pregnant women
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Maxillary Sinusitis
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Intervention(s)
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Procedure: treatment of chronic maxillary sinusitis using DIVA system
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Device: "dynamic implant valve approach" - DIVA system
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Primary Outcome(s)
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resolution of chronic maxillary sinusitis
[Time Frame: three months]
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Secondary ID(s)
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0015-17-NHR
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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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