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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01505335
First received: January 4, 2012
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Comparison Between Ultrasound and Clinical Measurements
Device: US depth measurements

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Use of Novel us Device (Jetguide) to Measure the Distance to the Roof of the IAC (Inferior Alveolar Canal)

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Estimated Enrollment: 25
Study Start Date: January 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • pacemakers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505335

Locations
Israel
Rambam Health Care Campus, Dept. of Periodontology
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Prof. Eli Machtei Rambam Health Care Campus, Haifa, Israel
  More Information

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01505335     History of Changes
Other Study ID Numbers: 0460-11-RMB CTIL
Study First Received: January 4, 2012
Last Updated: January 5, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Rambam Health Care Campus:
alveolar nerve, inferior
ultrasound
digital radiography, dental
nerve injury

ClinicalTrials.gov processed this record on November 20, 2014