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Morphologic ChangeNCT04567654

Assessment of the Relationship Between Mandibular Third Molars' Roots & the Covering Lingual Cortex Among Egyptian Population Using CBCT

An observational study of Morphologic Change and Number of Roots, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Morphologic Change, Number of Roots
How many people
304 participants
Where
No sites listed yet
Study dates
1 Jan 2022to 1 Oct 2022
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 18 to 65 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Assessment of the Topographic Relationship Between Mandibular Third Molars' Roots and the Covering Lingual Cortex in a Sample of Egyptian Population Using CBCT: An Observational Cross-Sectional Study

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

Read the detailed description

Setting and Location:

The CBCT data of this study will be obtained from the CBCT database available at the Department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University, Cairo, Egypt. Being a retrospective study, CBCT scans of Egyptian patients who have already been subjected to CBCT examination as part of their dental diagnosis and/or treatment planning will be included according to the proposed eligibility criteria.

Participants:

Based on sample size calculation, a sample of 304 mandibular third molar teeth belonging to Egyptian individuals will be examined. The selection of the scans to be included will be based on the following eligibility criteria

Eligibility criteria and selection method:

Inclusion criteria:

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.

Exclusion criteria:

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.

  • Matching criteria and allocation ratio: Not applicable in the study.

Variables:

  • Details about variable:
  1. Relationship between mandibular third molars' roots and covering lingual cortex
  2. Morphology of lingual cortex around mandibular third molars.
  3. Variation in number of roots of mandibular third molars.
  • Data Sources / Measurements:

Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.

Exposure parameters of the scans will vary depending on the individual patient's sizes

CBCT scans showing mandibular third molars with a maximum of 0.4 mm voxel size will be reviewed.

CBCT images will be analyzed using Planmeca Romexis® Viewer software, where the sagittal and coronal cross-sectional images will be oriented to be aligned with the long axis of the roots, together with the help of axial cross-sectional images for proper evaluation.

On the cross-sectional image, the relationship between mandibular third molars' roots and covering lingual cortex will be assessed at two levels (root apex and most lingual portion on apical one half) according to Emes classification: type A (non-contact), type B (contact), \& type C (perforation).

The lingual cortex morphology around mandibular third molars' roots will also be assessed on the cross-sectional image according to the modified classification by Chan \& Momin: Type U, undercut on the lingual side; Type P, parallel to the buccal plate; Type S, slanted with buccolingual width reduced on the lingual side, and Type R, round shape on the lingual side).

CBCT images will be interpreted by two oral radiologists independently; blinded from demographic data of the patients and from the results of each other.

Each radiologist will evaluate the images for assessment of number of roots, their relationship with covering the lingual cortex, and lingual cortex morphology. Then one of them will re-evaluate the images twice with two weeks interval between the two reading sessions.

Intra-observer and inter-observer and variability between the observers will be evaluated.

  • Addressing potential sources of bias:

No source of bias. CBCT images will be interpreted by two oral and maxillofacial radiologists independently blinded from demographic data of the patients and from the results of each other.

Study Size:

The aim of this study is to detect the topographic relationship between mandibular third molars' roots and covering lingual cortex, lingual cortex morphology and variation in number of roots.

This power analysis used the relation between the lingual plate of bone and third molars' roots. Based upon Wang's results, the percentage of subjects with contact and perforation of lingual cortical plate was 72.8% using Alpha (α) level of (5%), acceptable margin of error = 5%, the minimum estimated sample size was 304 mandibular third molar teeth

Sample size calculation was performed using EPI Info 7.2.2.2.

Quantitative variables

  • Handling of quantitative variables in analyses

Topographic relationship with the covering lingual cortex will be detected and categorically classified according to Emes classification: Type A (non-contact), Type B (contact), and type C (perforation).

The lingual cortex morphology will be detected and categorically classified according to modified Chan \& Momin classification: (Type U, undercut on the lingual side; Type P, parallel to the buccal plate; Type S, slanted with bucco-lingual width reduced on the lingual side, and Type R, round shape on the lingual side).

The number of mandibular third molar roots will be numerically counted to estimate the variations in the Egyptian population.

Statistical methods:

  • Statistical methods. Data will be statistically analyzed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 23.0, Armonk, NY: IBM Corp. Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percentages.

A p-value less than or equal to 0.05 will be considered statistically significant. All tests will be two-tailed.

Keywords
mandibular third molars, mandibular third molars' roots, Lingual cortex, lingual cortex morphology, number of roots

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 2 months

Secondary outcomes (1)
  1. Assessment of lingual cortex morphology around roots of mandibular third molars

    The lingual cortex morphology will undergo Categorical assessment according to modified Chan \& Momin classification: (Type U, undercut on the lingual side; Type P, parallel to the buccal plate; Type S, slanted with bucco-lingual width reduced on the lingual side, and Type R, round shape on the lingual side).

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2020
  2. Study start1 Jan 2022 (estimated)
  3. Primary completion1 Apr 2022 (estimated)
  4. Study completion1 Oct 2022 (estimated)

Resources

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
Other
Time perspective
Retrospective
Enrolment
304 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04567654
Sponsor's protocol ID
RAD 7-1-1
Status last verified
Sep 2020
First submitted
17 Sep 2020
Last updated
10 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Still to decide whether to share it or not

Questions about this trial

What is this clinical trial studying?

An observational study of Morphologic Change and Number of Roots, run by Cairo University.

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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Assessment of Topographic relationship Between mandibular third molars roots and the covering lingual cortex (time frame: 2 months). 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 10 Aug 2021.

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