The Use of Novel us Device (Jetguide) to Measure the Distance to the Roof of the IAC (Inferior Alveolar Canal)
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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) |
| 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:
|
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 |
Subjects attentding the clinic, requiring dental implant therapy in the posterior part of the lower jaw.
Inclusion Criteria:
- missing teeth in the premolar and molar areas of the lower jaw
Exclusion Criteria:
- pregnancy
- pacemakers
Contacts and Locations| Israel | |
| Rambam Health Care Campus, Dept. of Periodontology | |
| Haifa, Israel, 31096 | |
| 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 May 19, 2013