NCT04800003

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 15, 2021

Last Update Submit

March 15, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2 months

Study Arms (1)

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.

Diagnostic Test: Gonial angle and submandibular fossa depth measurements from CBCT images

Interventions

CBCT images were obtained from dry human mandibles

Dry human mandibles, selected for evaluation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Dry mandibles with sufficient bone integrity to make the necessary measurements

You may not qualify if:

  • Dry mandibles which were dentate in the posterior region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Ankara, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 16, 2021

Study Start

July 1, 2019

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

March 16, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations