NCT05128565

Brief Summary

The aim of this study is to investigate if GLCM texture features are correlated with age-gender trabecular bone variations in different regions of interest on mandibular CBCT scans. This correlation will help in guiding the future selection of textural features and anatomical regions suitable for developing a potential screening method for age and sex related skeletal disorders.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2021

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

1.5 years

First QC Date

November 3, 2021

Last Update Submit

November 18, 2021

Conditions

Keywords

texture analysistexture featurescancellous bone

Outcome Measures

Primary Outcomes (1)

  • Grey level co-occurrence matrix texture features

    Grey level co-occurrence matrix textural features (Entropy- Contrast-Angular second moment-Correlation-Sum of squares-Inverse difference moment-Sum of averages-Sum of variance-Sum of entropy-Difference of variance-Difference of entropy)

    Through study completion, an average of 18 months

Secondary Outcomes (1)

  • Correlation

    Through study completion, an average of 18 months

Study Arms (4)

Females under 40

females from 18 years old to 40 years old

Males under 40

males from 18 years old to 40 years old

Females above 40

females older than 40 years old

Males above 40

males older than 40 years old

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible mandibular CBCT scans of adult Egyptian population performed for any diagnostic reason other than this study will be retrieved from the database of oral and maxillofacial radiology department, faculty of dentistry, Cairo University.

You may qualify if:

  • Mandibular CBCT scans of an acceptable quality (devoid of imaging artifacts).
  • Egyptian male or female patients older than 18 years old.
  • Trabecular bone is free of pathology.
  • Teeth are present at the region of interest

You may not qualify if:

  • Low quality CBCT scans.
  • CBCT scans not including region of interest.
  • CBCT scans for patients less than 18 years old.
  • Trabecular bone is affected by osteolytic or osteoblastic bone pathologies.
  • The region of interest is apical to a missing tooth or a restored tooth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of oral and maxillofacial radiology

Study Record Dates

First Submitted

November 3, 2021

First Posted

November 22, 2021

Study Start

December 1, 2021

Primary Completion

June 1, 2023

Study Completion

August 1, 2023

Last Updated

November 22, 2021

Record last verified: 2021-11