Endosseous Oroantral Port for Minimal Intervention in Treating Chronic Sinusitis

March 13, 2017 updated by: ruth angel dar, Western Galilee Hospital-Nahariya
This study is intended to evaluate the efficiency of utilizing "dynamic implant valve approach" (DIVA) system in treating chronic maxillary sinusitis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Nahariya, Israel
        • Western Galilee Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Galilee Hospital-Nahariya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2017

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

March 5, 2017

First Submitted That Met QC Criteria

March 13, 2017

First Posted (Actual)

March 20, 2017

Study Record Updates

Last Update Posted (Actual)

March 20, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0015-17-NHR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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