NCT04567654

Brief Summary

A cross-sectional study to assess the Topographic Relationship between Mandibular Third Molars' Roots and the Covering Lingual Cortex in a Sample of Egyptian Population using CBCT through retrospective data analysis

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
304

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

September 17, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

August 10, 2021

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

September 17, 2020

Last Update Submit

August 8, 2021

Conditions

Morphologic ChangeNumber of Roots

Keywords

mandibular third molarsmandibular third molars' rootsLingual cortexlingual cortex morphologynumber of roots

Outcome Measures

Primary Outcomes (1)

  • Assessment of Topographic relationship Between mandibular third molars roots and the covering lingual cortex

    The topographic relationship between roots and lingual cortex will undergo categorical assessment according to Emes classification: Type A (non-contact), Type B (contact), and type C (perforation)

    2 months

Secondary Outcomes (1)

  • Assessment of lingual cortex morphology around roots of mandibular third molars

    2 months

Other Outcomes (1)

  • Assessment of variation in number of roots

    2 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Egyptian population aging from 18 to 65 years old showing Mandibular third molars (Erupted \&/or impacted) who have already been subjected to CBCT examination as part of their dental diagnosis and/or treatment planning

You may qualify if:

  • CBCT scans should show Mandibular third molars (Erupted \&/or impacted) of Egyptian patients aging from 18 to 65 years old.
  • Mandibular third molars showing complete root formation.
  • Intact lingual cortex as well as intact mandibular third molars' roots.
  • CBCT scans of different fields of view (quadrant, single, or inter-arch) could be included as they show the mandibular third molars.
  • CBCT scans of a maximum of 0.4 mm voxel resolution will be included.

You may not qualify if:

  • Mandibular third molars with developmental anomalies, external or internal root resorption, root canal calcification, previous root canal treatment, post restorations, and/or root caries.
  • Mandibular third molars with any pathology associated with and/or surrounding their roots.
  • CBCT images of sub-optimal quality or artifacts/high scatter interfering with proper assessment.

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
Principal Investigator

Study Record Dates

First Submitted

September 17, 2020

First Posted

September 28, 2020

Study Start

January 1, 2022

Primary Completion

April 1, 2022

Study Completion

October 1, 2022

Last Updated

August 10, 2021

Record last verified: 2020-09