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Endosseous Oroantral Port for Minimal Intervention in Treating Chronic Sinusitis

This study is not yet open for participant recruitment.
Verified March 2017 by ruth angel dar, Western Galilee Hospital-Nahariya
Sponsor:
ClinicalTrials.gov Identifier:
NCT03083392
First Posted: March 20, 2017
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
ruth angel dar, Western Galilee Hospital-Nahariya
  Purpose
This study is intended to evaluate the efficiency of utilizing "dynamic implant valve approach" (DIVA) system in treating chronic maxillary sinusitis.

Condition Intervention
Maxillary Sinusitis Procedure: treatment of chronic maxillary sinusitis using DIVA system Device: "dynamic implant valve approach" - DIVA system

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endosseous Oroantral Port for Minimal Intervention in Treating Chronic Sinusitis

Resource links provided by NLM:


Further study details as provided by ruth angel dar, Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • resolution of chronic maxillary sinusitis [ Time Frame: three months ]
    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)


Estimated Enrollment: 20
Anticipated Study Start Date: March 2017
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
treatment of chronic maxillary sinusitis using DIVA system
Procedure: treatment of chronic maxillary sinusitis using DIVA system
chronic maxillary sinusitis treatment utilizing DIVA system for antral lavage
Device: "dynamic implant valve approach" - DIVA system
The DIVA system will be used to apply saline lavage to the maxillary sinus

Detailed Description:

A prospective study aimed to test the efficiency of a minimal interventional approach in treating chronic maxillary sinusitis. The "dynamic implant valve approach" (DIVA), a minimally invasive approach utilizes a dental implant, designed with an internal sealing screw that might serve as drug delivery system via its channel. The implant is inserted to a posterior maxillary edentulous area, creating a connection between the sinus cavity and the oral cavity (Oro-antral connection), hence, provides a controlled working channel for diagnosis and treatment of the disease (e.g; allowing drainage, lavage and sinus endoscopy). The implant is a medical device approved for use at the anatomical area of interest.

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.

  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083392


Contacts
Contact: Ruth Angel-Dar, Dr. +972-4-9107076 rutiangel123@gmail.com
Contact: Samer Srouji, Prof. +972-4-9107270 dr.samersrouji@gmail.com

Locations
Israel
Western Galilee Medical Center Not yet recruiting
Nahariya, Israel
Contact: Sigal Shor    +972-4-9107270    sigal.shor@naharia.health.gov.il   
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Investigators
Study Director: Samer Srouji, Prof. Western Galilee Medical Center
  More Information

Publications:

Responsible Party: ruth angel dar, Principal Investigator, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT03083392     History of Changes
Other Study ID Numbers: 0015-17-NHR
First Submitted: March 5, 2017
First Posted: March 20, 2017
Last Update Posted: March 20, 2017
Last Verified: March 2017

Keywords provided by ruth angel dar, Western Galilee Hospital-Nahariya:
DIVA
sinusitis
maxillary

Additional relevant MeSH terms:
Sinusitis
Maxillary Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases