Linear Measurement Between Roots of Mandibular Premolars & Molar & IACNCT03537209
Assessment Root Apex Position of Mandibular Molars and Premolars Linear to Inferior Alveolar Canal Among Egyptian Population Using CBCT
An observational study of Linear Measurement Between Roots of Mandibular Premolars & Molar & IAC, run by Cairo University.
Trial summary
Linear relation between premolars and molars root apex and superior border of inferior alveolar canal Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Linear Measurement Between Roots of Mandibular Premolars & Molar & IAC
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 1 Nov 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult Egyptian population
Who may be able to join
- First and second mandibular permanent premolars and molars of Egyptian patients starting from 18 years, males or females.
- Intact roots without fractures or cracks.
- Posterior teeth are present and their adjacent and opposing teeth.
- Absence of radiological evidence of dental malocclusion that could have altered the position of premolars or molars.
- CBCT scans of mandibular first and second premolars and molars using 20 x 10 cm FOV, 0.4mm voxel resolution.
Who cannot join
- Evidence of apicectomy or periapical surgery.
- Odontogenic or non-odontogenic pathology.
- Congenital deformity of the mandible.
- External Root resorption.
- Previous history of fracture of the mandible.
- Tomographic images of poor quality or artifacts interfering with the detection of mandibular canal and apical morphology of the teeth.
About this study
Official title: Assessment of Root Apex Position of Mandibular Molars and Premolars Linear to Inferior Alveolar Canal Among a Sample of Egyptian Population Using CBCT: A Cross Sectional Study
Linear relation between premolars and molars root apex and superior border of inferior alveolar canal
Read the detailed description
The aim of the study is to assess the linear position between the roots of mandibular premolars and molars and the superior border of inferior alveolar canal.
Population: Adults, male and female from Egyptian population Outcome Variable: Linear measurement of the distance between root apices of mandibular premolars and molars to the superior border of IAN.
Outcome Measured Measuring Device Measuring Unit
Primary Outcome Distance between root apices of mandibular premolars and molars to inferior alveolar canal CBCT software Romexis® Millimeters
Research question:
Among the mandibular premolars and molars, which roots are the closest to the inferior alveolar canal, in sample of Egyptian Population?
Materials and Methods
Study Design: Cross-sectional Study
Setting and Location:
- The data collection will be obtained from the data base available at Oral \& Maxillofacial Radiology department at faculty of Dentistry, Cairo University.
- CBCT images will be obtained from Egyptian patients who had CBCT examination as part of their dental examination, diagnosis or treatment planning during the years 2018.
Participants:
A total of 162 CBCT scans of mandibular permanent premolars and molars belonging to Egyptian individuals are selected according to the following:
Inclusion criteria:
- First and second mandibular permanent premolars and molars of Egyptian patients starting from 18 years, males or females.
- Intact roots without fractures or cracks.
- Posterior teeth are present and their adjacent and opposing teeth.
- Absence of radiological evidence of dental malocclusion that could have altered the position of premolars or molars.
- CBCT scans of mandibular first and second premolars and molars using 20 x 10 cm FOV, 0.4mm voxel resolution.
Exclusion criteria:
- Evidence of apicectomy or periapical surgery.
- Odontogenic or non-odontogenic pathology.
- Congenital deformity of the mandible.
- External Root resorption.
- Previous history of fracture of the mandible.
- Tomographic images of poor quality or artifacts interfering with the detection of mandibular canal and apical morphology of the teeth.
Variables:
- The crowding and overlapping of the mandibular posterior teeth .
- Extraction of the adjacent or the opposing tooth may cause tilting of the tooth or over eruption of the opposing tooth.
- Attrition of the teeth may cause over eruption of the teeth.
- The presence of dental anamolies may influence the position of the tooth to the inferior alveolar canal.
Data Sources / Measurements:
Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database by convenient sampling technique.
CBCT images will be obtained from patients who required CBCT examination as part of their dental examination, diagnosis or treatment planning without exposing them to unnecessary radiation dose for the research purpose.
All the CBCT examinations are scanned by Planmeca Promax 3D®, 20 x 10 cm FOV, 0.4 mm voxel resolution, 90 kVp, 8 mA and 13.5 seconds exposure time.
To assess the shortest distance from the root apices to the border of the inferior alveolar canal, the multiplanar reconstruction view of the manufacturer's software viewer (Planmeca Romexis) with its axial, sagittal and coronal plane will be used, and the cross-sectional images through the mandible will be also used.
Cross sectional images will be oriented parallel to the long axis of the tooth, then the shortest distance from the deepest point of root apices and superior border of the inferior alveolar canal will be obtained to be examined (Umut et al 2017).
CBCT images will be interpreted by two oral radiologists independently; blinded from demographic data of the patients and from the results of each other.
All measurements will be assessed, once by the first investigator and then another time two weeks later for intra-observer reliability. The second investigator will assess the measurements once for inter-observer reliability.
Then inter-observational and intra-observational variability between the observers will be evaluated.
Bias:
No source of bias.
Study Size:
The aim of the study is to assess the relationship between the roots of mandibular premolars and molars and the superior border of inferior alveolar canal in Egyptian population. Based on the previous paper by San Chong,et al,2017,the prevalence of alveolar nerve 78%.Using a precision of 5, a design effect set at 1 with 95%CI(confidence interval), a total sample size of 162 will be sufficient. The sample size was calculated by Epi info.
Sampling Strategy: The sample will be collected by convenient sampling technique.
Statistical Methods:
Data will be analyzed using IBM SPSS advanced statistics ( Statisitcal Package for Social Sciences), version 24 (SPSS Inc.,Chicago,IL). Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percantages. Comparsions between male and females for normally distributed numeric variables will be done using Student's t-test while for non-normally distributed numeric variables will be done by Mann-Whitney test. Comparisons between categorical variables will be performed using the chi square test, A p-value less than or equal to 0.05 will be considered statistically significant. All tests will be tailed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between root apices of mandibular premolars and molars to inferior alveolar canal
measurement in millimeters using CBCT software Romexis®
Measured: 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start1 Jul 2018 (estimated)
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Linear Measurement Between Roots of Mandibular Premolars & Molar & IACStudies 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
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farid Medhat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537209
- Sponsor's protocol ID
- Rad 2:5:1
- Status last verified
- May 2018
- First submitted
- 10 May 2018
- Last updated
- 25 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Root Apex Position of Mandibular Molars and Premolars Linear to Inferior Alveolar Canal Among a Sample of Egyptian Population Using CBCT: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03537209
- Acronym / sponsor ID
- Rad 2:5:1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 25 May 2018 (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.
Linear relation between premolars and molars root apex and superior border of inferior alveolar canal
Detailed description
The aim of the study is to assess the linear position between the roots of mandibular premolars and molars and the superior border of inferior alveolar canal.
Population: Adults, male and female from Egyptian population Outcome Variable: Linear measurement of the distance between root apices of mandibular premolars and molars to the superior border of IAN.
Outcome Measured Measuring Device Measuring Unit
Primary Outcome Distance between root apices of mandibular premolars and molars to inferior alveolar canal CBCT software Romexis® Millimeters
Research question:
Among the mandibular premolars and molars, which roots are the closest to the inferior alveolar canal, in sample of Egyptian Population?
Materials and Methods
Study Design: Cross-sectional Study
Setting and Location:
- The data collection will be obtained from the data base available at Oral \& Maxillofacial Radiology department at faculty of Dentistry, Cairo University.
- CBCT images will be obtained from Egyptian patients who had CBCT examination as part of their dental examination, diagnosis or treatment planning during the years 2018.
Participants:
A total of 162 CBCT scans of mandibular permanent premolars and molars belonging to Egyptian individuals are selected according to the following:
Inclusion criteria:
- First and second mandibular permanent premolars and molars of Egyptian patients starting from 18 years, males or females.
- Intact roots without fractures or cracks.
- Posterior teeth are present and their adjacent and opposing teeth.
- Absence of radiological evidence of dental malocclusion that could have altered the position of premolars or molars.
- CBCT scans of mandibular first and second premolars and molars using 20 x 10 cm FOV, 0.4mm voxel resolution.
Exclusion criteria:
- Evidence of apicectomy or periapical surgery.
- Odontogenic or non-odontogenic pathology.
- Congenital deformity of the mandible.
- External Root resorption.
- Previous history of fracture of the mandible.
- Tomographic images of poor quality or artifacts interfering with the detection of mandibular canal and apical morphology of the teeth.
Variables:
- The crowding and overlapping of the mandibular posterior teeth .
- Extraction of the adjacent or the opposing tooth may cause tilting of the tooth or over eruption of the opposing tooth.
- Attrition of the teeth may cause over eruption of the teeth.
- The presence of dental anamolies may influence the position of the tooth to the inferior alveolar canal.
Data Sources / Measurements:
Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database by convenient sampling technique.
CBCT images will be obtained from patients who required CBCT examination as part of their dental examination, diagnosis or treatment planning without exposing them to unnecessary radiation dose for the research purpose.
All the CBCT examinations are scanned by Planmeca Promax 3D®, 20 x 10 cm FOV, 0.4 mm voxel resolution, 90 kVp, 8 mA and 13.5 seconds exposure time.
To assess the shortest distance from the root apices to the border of the inferior alveolar canal, the multiplanar reconstruction view of the manufacturer's software viewer (Planmeca Romexis) with its axial, sagittal and coronal plane will be used, and the cross-sectional images through the mandible will be also used.
Cross sectional images will be oriented parallel to the long axis of the tooth, then the shortest distance from the deepest point of root apices and superior border of the inferior alveolar canal will be obtained to be examined (Umut et al 2017).
CBCT images will be interpreted by two oral radiologists independently; blinded from demographic data of the patients and from the results of each other.
All measurements will be assessed, once by the first investigator and then another time two weeks later for intra-observer reliability. The second investigator will assess the measurements once for inter-observer reliability.
Then inter-observational and intra-observational variability between the observers will be evaluated.
Bias:
No source of bias.
Study Size:
The aim of the study is to assess the relationship between the roots of mandibular premolars and molars and the superior border of inferior alveolar canal in Egyptian population. Based on the previous paper by San Chong,et al,2017,the prevalence of alveolar nerve 78%.Using a precision of 5, a design effect set at 1 with 95%CI(confidence interval), a total sample size of 162 will be sufficient. The sample size was calculated by Epi info.
Sampling Strategy: The sample will be collected by convenient sampling technique.
Statistical Methods:
Data will be analyzed using IBM SPSS advanced statistics ( Statisitcal Package for Social Sciences), version 24 (SPSS Inc.,Chicago,IL). Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percantages. Comparsions between male and females for normally distributed numeric variables will be done using Student's t-test while for non-normally distributed numeric variables will be done by Mann-Whitney test. Comparisons between categorical variables will be performed using the chi square test, A p-value less than or equal to 0.05 will be considered statistically significant. All tests will be tailed.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Egyptian population
Key inclusion criteria (5 listed)
- First and second mandibular permanent premolars and molars of Egyptian patients starting from 18 years, males or females.
- Intact roots without fractures or cracks.
- Posterior teeth are present and their adjacent and opposing teeth.
- Absence of radiological evidence of dental malocclusion that could have altered the position of premolars or molars.
- CBCT scans of mandibular first and second premolars and molars using 20 x 10 cm FOV, 0.4mm voxel resolution.
Key exclusion criteria (6 listed)
- Evidence of apicectomy or periapical surgery.
- Odontogenic or non-odontogenic pathology.
- Congenital deformity of the mandible.
- External Root resorption.
- Previous history of fracture of the mandible.
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
Distance between root apices of mandibular premolars and molars to inferior alveolar canal
Time frame: 2018
measurement in millimeters using CBCT software Romexis®
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Individual participant dataSharing planned: No
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 Linear Measurement Between Roots of Mandibular Premolars & Molar & IAC, 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 6 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 25 May 2018. 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?
Distance between root apices of mandibular premolars and molars to inferior alveolar canal (time frame: 2018). 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 25 May 2018.