Maxillary Sinusitis Clinical Trial
Official title:
Endosseous Oroantral Port for Minimal Intervention in Treating Chronic Sinusitis
This study is intended to evaluate the efficiency of utilizing "dynamic implant valve approach" (DIVA) system in treating chronic maxillary sinusitis.
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.
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