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

NCT ID: NCT01505335

Last Updated: 2012-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Comparison Between Ultrasound and Clinical Measurements

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Implant osteotomy measurements

Drilled implant locations

US depth measurements

Intervention Type DEVICE

Measurement of the distance between the apex of the drilled implant site and the IAC

Interventions

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US depth measurements

Measurement of the distance between the apex of the drilled implant site and the IAC

Intervention Type DEVICE

Other Intervention Names

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Jetguide Ultrasonic measurement device

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy
* pacemakers
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Eli Machtei

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus, Haifa, Israel

Locations

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Rambam Health Care Campus, Dept. of Periodontology

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0460-11-RMB CTIL

Identifier Type: -

Identifier Source: org_study_id

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