Dental ImplantsNCT04800003
The Gonial Angle as a Predictive Marker of Mandibular Fossa Depth
An observational study of Dental Implants and Submandibular Fossa Depth, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Submandibular Fossa Depth, Gonial Angle
- What is being tested?
- Gonial angle and submandibular fossa depth measurements from CBCT images
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Dry mandibles with sufficient bone integrity to make the necessary measurements
Who cannot join
- Dry mandibles which were dentate in the posterior region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Implants, Submandibular Fossa Depth, Gonial Angle, Cone-beam Computed Tomography, Panoramic Radiography
- Being tested
- Gonial angle and submandibular fossa depth measurements from CBCT images
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonial angle and submandibular fossa depth measurements from CBCT imagesDiagnostic test
CBCT images were obtained from dry human mandibles
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Gonial angle and submandibular fossa depth measurements from CBCT images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gonial angle
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.
Measured: 2 months
Submandibular fossa depth
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Jul 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Poyzan Bozkurt, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800003
- Sponsor's protocol ID
- 13/1
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gonial Angle as a Predictive Marker of Mandibular Fossa Depth on Panoramic Radiographs: A Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT04800003
- Acronym / sponsor ID
- 13/1
- Conditions
- Dental Implants, Submandibular Fossa Depth, Gonial Angle, Cone-beam Computed Tomography, Panoramic Radiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry human mandibles, selected for evaluation | – | Diagnostic Test: Gonial angle and submandibular fossa depth measurements from CBCT images51 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Dry mandibles with sufficient bone integrity to make the necessary measurements
Key exclusion criteria (1 listed)
- Dry mandibles which were dentate in the posterior region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gonial angle and submandibular fossa depth measurements from CBCT imagesCBCT images were obtained from dry human mandibles | Diagnostic test | Dry human mandibles, selected for evaluation |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants and Submandibular Fossa Depth, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gonial angle (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.