Maxillary SinusNCT03605394
Assessment of Maxillary Sinus Septum and Its Prevalence in a Sample of Egyptian Population (CBCT)
An observational study of Maxillary Sinus, run by Cairo University.
Trial summary
a cross-sectional study to estimate the prevalence of maxillary sinus septum and assessment of it in a sample of Egyptian Population using cone beam computed tomography through retrospective data analysis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Maxillary Sinus
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Mar 2019
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Egyptian Population
Who may be able to join
- • CBCT scans of partially, fully edentulous and dentulous population.
Who cannot join
- • CBCT scans that not displaying all the extension of the lower one third of the maxillary sinus.
- Presence of large pathological lesions involving the maxillary sinus or affecting the confines of the sinus floor.
- Images exhibiting changes in the morphology of sinus walls due to trauma.
- Presence of technical artifacts that make difficult the maxillary sinus evaluation.
About this study
Official title: Assessment of Maxillary Sinus Septum and Its Prevalence in a Sample of Egyptian Population Using 3D CBCT : A Cross-Sectional Study
a cross-sectional study to estimate the prevalence of maxillary sinus septum and assessment of it in a sample of Egyptian Population using cone beam computed tomography through retrospective data analysis
Read the detailed description
Setting and location:
- The data collection will be obtained from the data base available at the department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University, Cairo, Egypt.
- CBCT images will be obtained from Egyptian patients who had CBCT examination as part of their dental examination, diagnosis or treatment planning.
Participants:
A total sample of 111examined sinus belonging to Egyptian individuals will be included.
Variables:
- Prevalence of maxillary sinus septa.
- Location of maxillary sinus septa.
- Orientation of maxillary sinus septa in dentulous \& edentulous individual.
Data Sources / Measurements:
- Retrospective Data collection will be performed after the CBCT images are pooled from the computer database.
- All the CBCT examinations will be scanned using CBCT machine (Planmeca promax 3D Mid).
- CBCT scans using different fields of view, and different voxel resolutions .
- 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 one will evaluate the images separately twice with a period of two weeks between the two reading sessions.
- Then inter-observational and intra-observational variability between the observers will be evaluated.
Bias:
No source of bias.
Study Size:
The results showed that a total sample size of 111examined sinus will be adequate to detect sinus septum prevalence of 24.6% with an 8% margin of error, a significance level of 5% and a 95% confidence interval.
Quantitative Variables:
The number of CBCT scans of Egyptian individuals with maxillary sinus septa will be counted to estimate the variations in the Egyptian population.
Statistical methods:
Data will be analysed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 21 (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 percentages.
- Conditions
- Maxillary Sinus
- Keywords
- Maxillary sinus, sinus septa, sinus septum, CBCT
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of maxillary sinus septa
Measuring device is CBCT Software on Planmeca Promax 3D Mid,Measuring unit is Percentage
Measured: in the years 2017-2018-2019
Secondary outcomes (1)
Location of maxillary sinus septa
Measuring device is CBCT Software on Planmeca Promax 3D Mid,Measuring unit is Percentage
Measured: in the years 2017-2018-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study startAug 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary SinusStudies 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
- 111 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
- NCT03605394
- Sponsor's protocol ID
- RAD1:6:2
- Status last verified
- Jul 2018
- First submitted
- 22 Jul 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- 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 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Maxillary Sinus Septum and Its Prevalence in a Sample of Egyptian Population Using 3D CBCT : A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT03605394
- Acronym / sponsor ID
- RAD1:6:2
- Conditions
- Maxillary Sinus
- Keywords
- Maxillary sinus, sinus septa, sinus septum, CBCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 30 Jul 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.
a cross-sectional study to estimate the prevalence of maxillary sinus septum and assessment of it in a sample of Egyptian Population using cone beam computed tomography through retrospective data analysis
Detailed description
Setting and location:
- The data collection will be obtained from the data base available at the department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University, Cairo, Egypt.
- CBCT images will be obtained from Egyptian patients who had CBCT examination as part of their dental examination, diagnosis or treatment planning.
Participants:
A total sample of 111examined sinus belonging to Egyptian individuals will be included.
Variables:
- Prevalence of maxillary sinus septa.
- Location of maxillary sinus septa.
- Orientation of maxillary sinus septa in dentulous \& edentulous individual.
Data Sources / Measurements:
- Retrospective Data collection will be performed after the CBCT images are pooled from the computer database.
- All the CBCT examinations will be scanned using CBCT machine (Planmeca promax 3D Mid).
- CBCT scans using different fields of view, and different voxel resolutions .
- 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 one will evaluate the images separately twice with a period of two weeks between the two reading sessions.
- Then inter-observational and intra-observational variability between the observers will be evaluated.
Bias:
No source of bias.
Study Size:
The results showed that a total sample size of 111examined sinus will be adequate to detect sinus septum prevalence of 24.6% with an 8% margin of error, a significance level of 5% and a 95% confidence interval.
Quantitative Variables:
The number of CBCT scans of Egyptian individuals with maxillary sinus septa will be counted to estimate the variations in the Egyptian population.
Statistical methods:
Data will be analysed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 21 (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 percentages.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Egyptian Population
Key inclusion criteria (1 listed)
- • CBCT scans of partially, fully edentulous and dentulous population.
Key exclusion criteria (4 listed)
- • CBCT scans that not displaying all the extension of the lower one third of the maxillary sinus.
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
prevalence of maxillary sinus septa
Time frame: in the years 2017-2018-2019
Measuring device is CBCT Software on Planmeca Promax 3D Mid,Measuring unit is Percentage
1 secondary outcome
Location of maxillary sinus septa
Time frame: in the years 2017-2018-2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Individual participant dataSharing planned: No
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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 Maxillary Sinus, 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 1 inclusion and 4 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 31 Jul 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?
prevalence of maxillary sinus septa (time frame: in the years 2017-2018-2019). 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 31 Jul 2018.