Endosseous Oroantral Port for Minimal Intervention in Treating Chronic Sinusitis
1 other identifier
interventional
20
1 country
1
Brief Summary
This study is intended to evaluate the efficiency of utilizing "dynamic implant valve approach" (DIVA) system in treating chronic maxillary sinusitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 5, 2017
CompletedFirst Posted
Study publicly available on registry
March 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMarch 20, 2017
March 1, 2017
1 year
March 5, 2017
March 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
resolution of chronic maxillary sinusitis
After three months of follow-up, the patient will be assessed by a combination of medical tests (clinical, endoscopic and radiologic assessment), in order to determine if the maxillary sinusitis has completely resolved. The investigators expect to see complete resolution of the sinus pathological state (e.g. no evidence of sinusitis)
three months
Study Arms (1)
Treatment
EXPERIMENTALtreatment of chronic maxillary sinusitis using DIVA system
Interventions
chronic maxillary sinusitis treatment utilizing DIVA system for antral lavage
The DIVA system will be used to apply saline lavage to the maxillary sinus
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Western Galilee Medical Center
Nahariya, Israel
Related Publications (7)
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.
PMID: 22186252BACKGROUNDFokkens 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.
PMID: 22469599BACKGROUNDLudlow 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.
PMID: 18504152BACKGROUNDNahlieli 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.
PMID: 21050639BACKGROUNDNahlieli 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.
PMID: 24278950BACKGROUNDNeugebauer 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.
PMID: 20369083BACKGROUNDRosenfeld 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.
PMID: 17761281BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Samer Srouji, Prof.
Western Galilee Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 5, 2017
First Posted
March 20, 2017
Study Start
March 1, 2017
Primary Completion
March 1, 2018
Study Completion
March 1, 2019
Last Updated
March 20, 2017
Record last verified: 2017-03