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.
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:
- Relationship between mandibular third molars' roots and covering lingual cortex
- Morphology of lingual cortex around mandibular third molars.
- 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.
- Conditions
- Morphologic Change, Number of Roots
- 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.
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)
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.
- First posted28 Sep 2020
- Study start1 Jan 2022 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morphologic ChangeStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Hossam Kandil, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04567654
- Acronym / sponsor ID
- RAD 7-1-1
- Conditions
- Morphologic Change, Number of Roots
- Keywords
- mandibular third molars, mandibular third molars' roots, Lingual cortex, lingual cortex morphology, number of roots
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 28 Sep 2020 (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.
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
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:
- Relationship between mandibular third molars' roots and covering lingual cortex
- Morphology of lingual cortex around mandibular third molars.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Topographic relationship Between mandibular third molars roots and the covering lingual cortex
Time frame: 2 months
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)
1 secondary outcome
Assessment of lingual cortex morphology around roots of mandibular third molars
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: Undecided. Still to decide whether to share it or not
Related trials for Morphologic Change
RecruitingObservational study
Gender-Affirming Hormone Therapy and Its Impact on Myocardial Mass and Cardiac Function, Heart, Liver and Pancreatic Fat Content
Gender Dysphoria, Hormone Therapy Induced Morphologic Change
RecruitingObservational study
Changes in Body Fat and Morphologic Characteristics Associated With OSA Resolution After Bariatric Surgery
Obesity, Obstructive Sleep Apnea
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.
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.