The Use of Novel us Device (Jetguide) to Measure the Distance to the Roof of the IAC (Inferior Alveolar Canal)

January 5, 2012 updated by: Rambam Health Care Campus
The purpose of this human clinical trial is to validate the accuracy of Jetguide® US device in detecting the inferior alveolar canal (IAC) and to compare it to measurements performed on computerized tomography images.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To date, the most accurate method to assess the distance from the alveolar crest to the IAC is cone beam computerized tomography (CBCT). This technique carries with it some potential concerns, including measurements errors, inability to perform intra-operative radiographs substantial financial and radiation costs.

In the present study patients will have a CBCT of the mandible taken. Sites where implants will be inserted will be marked on the CBCT, measurements of the distance from bone crest to the roof of the inferior alveolar canal (BC-IAC) will be performed.

During implant surgery the depth of the osteotomy (OD) will be measured using a periodontal probe; OD and the distance from the bottom of the osteotomy to the roof of the IAC (residual distance - RD) will be measured using a standard JetGuide® device. In addition, standard panoramic radiographs will be taken with a surgical gauge in the osteotomy which will enable us to measure the RD radiographically.

The correlation between the radiographic and clinical BC-IAC distance will be the primary outcome variable. The same correlation for the RD between the Jetguide readings and the linear measurements on the panoramic radiographs will serve as the secondary outcome variable.

Study Type

Observational

Enrollment (Anticipated)

25

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
      • Haifa, Israel, 31096
        • Rambam Health Care Campus, Dept. of Periodontology

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects attentding the clinic, requiring dental implant therapy in the posterior part of the lower jaw.

Description

Inclusion Criteria:

  • missing teeth in the premolar and molar areas of the lower jaw

Exclusion Criteria:

  • pregnancy
  • pacemakers

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Implant osteotomy measurements
Drilled implant locations
Device: US depth measurements
Measurement of the distance between the apex of the drilled implant site and the IAC
Other Names:
  • Jetguide
  • Ultrasonic measurement device

Collaborators and Investigators

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

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Prof. Eli Machtei, Rambam Health Care Campus, Haifa, Israel

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

January 1, 2012

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

January 4, 2012

First Submitted That Met QC Criteria

January 5, 2012

First Posted (Estimate)

January 6, 2012

Study Record Updates

Last Update Posted (Estimate)

January 6, 2012

Last Update Submitted That Met QC Criteria

January 5, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0460-11-RMB CTIL

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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