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

R

Rambam Health Care Campus

Status

Unknown

Conditions

Comparison Between Ultrasound and Clinical Measurements

Treatments

Device: US depth measurements

Study type

Observational

Funder types

Other

Identifiers

NCT01505335
0460-11-RMB CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • pregnancy
  • pacemakers

Trial design

25 participants in 1 patient group

Implant osteotomy measurements
Description:
Drilled implant locations
Treatment:
Device: US depth measurements

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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