Endosseous Oroantral Port for Minimal Intervention in Treating Chronic Sinusitis
NCT ID: NCT03083392
Last Updated: 2017-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2017-03-31
2019-03-31
Brief Summary
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Detailed Description
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The treatment method proposed in this study is based on the principle of a conventional treatment of washing the maxillary sinus cavity called "Antral puncture and lavage".
The changes that are proposed in this study could make the operation more convenient and effective in the therapeutic level, both for the patient and the clinician for the following reasons:
* DIVA (Dynamic Implant Valve Approach) Implant with a multi- useful working channel: the mere presence of the canal in the center of the implant with a screw seal, ensures controlled Oro-antral connection, and enables multiple endoscopy and lavage procedures until resolution of the pathological condition is achieved.
* The anatomical location of the puncture / penetration to the sinus - is performed in the maxillary edentulous region. This is the lowest area of the sinus cavity (standing or sitting posture), which utilizes gravity for drainage and extraction of the contaminated contents of the sinus.
By appropriate advance planning, the implant, after eradication of the disease, can later be used for prosthetic purposes.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
treatment of chronic maxillary sinusitis using DIVA system
treatment of chronic maxillary sinusitis using DIVA system
chronic maxillary sinusitis treatment utilizing DIVA system for antral lavage
"dynamic implant valve approach" - DIVA system
The DIVA system will be used to apply saline lavage to the maxillary sinus
Interventions
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treatment of chronic maxillary sinusitis using DIVA system
chronic maxillary sinusitis treatment utilizing DIVA system for antral lavage
"dynamic implant valve approach" - DIVA system
The DIVA system will be used to apply saline lavage to the maxillary sinus
Eligibility Criteria
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Inclusion Criteria
* 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
* patients who are not interested or need dental implants
* Patients with maxillary sinus neoplastic pathology
* Chronic maxillary sinusitis with polyps
* Pregnant women
18 Years
65 Years
ALL
No
Sponsors
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Western Galilee Hospital-Nahariya
OTHER_GOV
Responsible Party
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ruth angel dar
Principal Investigator
Principal Investigators
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Samer Srouji, Prof.
Role: STUDY_DIRECTOR
Western Galilee Medical Center
Locations
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Western Galilee Medical Center
Nahariya, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Albu S, Baciut M, Opincariu I, Rotaru H, Dinu C. The canine fossa puncture technique in chronic odontogenic maxillary sinusitis. Am J Rhinol Allergy. 2011 Sep-Oct;25(5):358-62. doi: 10.2500/ajra.2011.25.3673.
Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000.
Ludlow JB, Ivanovic M. Comparative dosimetry of dental CBCT devices and 64-slice CT for oral and maxillofacial radiology. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Jul;106(1):106-14. doi: 10.1016/j.tripleo.2008.03.018. Epub 2008 May 27.
Nahlieli O, Moshonov J, Zagury A, Michaeli E, Casap N. Endoscopic approach to dental implantology. J Oral Maxillofac Surg. 2011 Jan;69(1):186-91. doi: 10.1016/j.joms.2010.07.071. Epub 2010 Nov 2.
Nahlieli O, Casap N, Moshonov J, Zagury A, Michali E, Samuni Y. A novel dental implant system with an internal port for endoscopic closed sinus augmentation: a feasibility study in pigs. Int J Oral Maxillofac Implants. 2013 Nov-Dec;28(6):e556-61. doi: 10.11607/jomi.te36.
Neugebauer J, Ritter L, Mischkowski RA, Dreiseidler T, Scherer P, Ketterle M, Rothamel D, Zoller JE. Evaluation of maxillary sinus anatomy by cone-beam CT prior to sinus floor elevation. Int J Oral Maxillofac Implants. 2010 Mar-Apr;25(2):258-65.
Rosenfeld RM, Andes D, Bhattacharyya N, Cheung D, Eisenberg S, Ganiats TG, Gelzer A, Hamilos D, Haydon RC 3rd, Hudgins PA, Jones S, Krouse HJ, Lee LH, Mahoney MC, Marple BF, Mitchell CJ, Nathan R, Shiffman RN, Smith TL, Witsell DL. Clinical practice guideline: adult sinusitis. Otolaryngol Head Neck Surg. 2007 Sep;137(3 Suppl):S1-31. doi: 10.1016/j.otohns.2007.06.726.
Other Identifiers
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0015-17-NHR
Identifier Type: -
Identifier Source: org_study_id
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