- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04800003
The Gonial Angle as a Predictive Marker of Mandibular Fossa Depth
March 15, 2021 updated by: Poyzan Bozkurt, Ankara University
The Gonial Angle as a Predictive Marker of Mandibular Fossa Depth on Panoramic Radiographs: A Diagnostic Accuracy Study
The aim of the study is to evaluate the relationship between submandibular fossa depth and gonial angle measurements in cone beam computed tomography examinations in terms of dental implant applications.
Cone-beam computed tomography images of 51 dry human mandibles were included in the study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Gonial angle and fossa depths were determined and evaluated separately for left and right sides.
Gonial angle was measured on Cone-beam computed tomography images as the angle between the tangent line drawn posterior to the border of the ramus of the mandible and the tangent line drawn to the lower border of the mandible.
Determination of the submandibular fossa depth was made with a line was drawn to connect the most dislocated upper and lower points on the inner surface of the mandible in the coronal plane sections, and the length of the line drawn at a right angle from the deepest point of the fossa to this line.
Measurements were made separately for left and right sides.
Study Type
Observational
Enrollment (Actual)
74
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
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Ankara, Turkey
- Ankara University
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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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
In the present diagnostic accuracy study, 75 dry human mandibles were used.
24 dry human mandibles with insufficient bone integrity to make the necessary measurements or which were dentate in the posterior region were not included in the study and the study was carried out with 51 dry mandibles.
Description
Inclusion Criteria:
- Dry mandibles with sufficient bone integrity to make the necessary measurements
Exclusion Criteria:
- Dry mandibles which were dentate in the posterior region
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 |
|---|---|
|
Dry human mandibles, selected for evaluation
51 dry mandibles with posterior region endetulism and sufficient bone integrity to make the necessary measurements were evaluated.
CBCT images of the 51 dry human mandibles included in the study were obtained using the Planmeca Promex-3D (Helsinki, Finland) device in our faculty Dentomaxillofacial Radiology department.
Gonial angle was measured on CBCT images as the angle between the tangent line drawn posterior to the border of the ramus of the mandible and the tangent line drawn to the lower border of the mandible.
While determining the depth of the submandibular fossa, a line was drawn to connect the most dislocated upper and lower points on the inner surface of the mandible in the coronal plane sections obtained with CBCT, and the length of the line drawn at a right angle from the deepest point of the fossa to this line was measured as the depth of the submandibular fossa.
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CBCT images were obtained from dry human mandibles
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gonial angle
Time Frame: 2 months
|
Gonial angle and fossa depths were determined and evaluated separately for left and right sides.
Gonial angle was measured on CBCT images as the angle between the tangent line drawn posterior to the border of the ramus of the mandible and the tangent line drawn to the lower border of the mandible.
|
2 months
|
|
Submandibular fossa depth
Time Frame: 2 months
|
A line was drawn to connect the most dislocated upper and lower points on the inner surface of the mandible in the coronal plane sections obtained with CBCT, and the length of the line drawn at a right angle from the deepest point of the fossa to this line was measured as the depth of the submandibular fossa.
These measurements were noted as 'millimeters' separately for left and right sides.
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ACTUAL)
July 1, 2019
Primary Completion (ACTUAL)
August 31, 2019
Study Completion (ACTUAL)
August 31, 2019
Study Registration Dates
First Submitted
March 15, 2021
First Submitted That Met QC Criteria
March 15, 2021
First Posted (ACTUAL)
March 16, 2021
Study Record Updates
Last Update Posted (ACTUAL)
March 16, 2021
Last Update Submitted That Met QC Criteria
March 15, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 13/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.