Root Fenestation and DehiscenceNCT03471715
Frequency of Root Fenestration and Dehiscence in Adult Egyptian Population Using CBCT.
An observational study of Root Fenestation and Dehiscence, run by Cairo University.
Trial summary
observational crosssectional study to evaluate the Frequency of Root Fenestration and Dehiscence at Different Teeth Types in a Sample of Adult Egyptian Population Using Cone Beam Computed Tomography. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Root Fenestation and Dehiscence
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Aug 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 to 60 years
- All sexes
- Adult
Study population: Egyptian population
Who may be able to join
- a- CBCT scans of Adult Egyptian population with age range from 18 to 60 years old.
- b- The CBCT scans should fully show both maxillary and mandibular teeth with the surrounding alveolar bone.
- c- Permanent teeth with complete development of roots only are included. d- CBCT scans for both partially and fully dentated people are included. e- Lack of large pathological lesion. f- Lack of fracture either in teeth or alveolar bone.
Who cannot join
- CBCT scans of People younger than 18 or older than 60 years old.
- CBCT scans showing only single jaw.
- CBCT scans completely edentulous people.
- Teeth with incomplete root development are excluded.
- Teeth with unclear alveolar crest around it due to metallic artifacts from nearby restoration.
- Presence of large pathological lesions.
- Fractured teeth or alveolar process.
- -
About this study
Official title: Evaluation of Frequency of Root Fenestration and Dehiscence at Different Teeth Types in a Sample of Adult Egyptian Population Using Cone Beam Computed Tomography.
observational crosssectional study to evaluate the Frequency of Root Fenestration and Dehiscence at Different Teeth Types in a Sample of Adult Egyptian Population Using Cone Beam Computed Tomography.
Read the detailed description
**Data Collection:
The following data of the current retrospective study will be collected from the recruited CBCT images:-
- Demographic data: Age and Sex will be drawn from the patients' CBCT files.
- Variables: Outcome: Frequency of root fenestration and dehiscence at different teeth types in adult Egyptian population sample using CBCT. Radiographic examination was done at the Oral and Maxillofacial Radiology Department, Faculty of Dentistry, Cairo University using CBCT machine, Planmeca Promax 3D Mid (Finland) . Root fenestration (RF) will be identified according to the definition of Davies et al. 19 and the American Association of Endodontists 20 as a tooth root protruding from a window-like opening or a defect in the alveolar bone without involvement of the alveolar margin. Three points should be emphasized in this definition. 1- A window-like opening or defect of the alveolar bone means that both the cortical bone and the cancellous bone are penetrated simultaneously, and the root either is in direct contact with the overlying mucosa or exposed to the oral environment. 2- The exposed root protrudes beyond the bone. 3- The exclusion of the alveolar margin emphasized to differentiate fenestration from dehiscence. While dehiscence will be identified as the crest of buccal and lingual bone that lies at least 4mm apical to the crest of interproximal bone. The identification and measurements of the alveolar bone level will be made on CBCT cross sectional images that are corrected to be with the long axis of each tooth under examination. All assessment will be done by two examiners to eliminate the inter-examiner error. All data regarding patient identification will be kept confidential. **Participants: Eligibility criteria
- Inclusion criteria:
- CBCT scans of Adult Egyptian population with age range from 18 to 60 years old.
- The CBCT scans should fully show both maxillary and mandibular teeth with the surrounding alveolar bone.
- Permanent teeth with complete development of roots only are included.
- CBCT scans for both partially and fully dentated people are included.
- Lack of large pathological lesion.
- Lack of fracture either in teeth or alveolar bone.
- Exclusion criteria:
- CBCT scans of People younger than 18 or older than 60 years old.
- CBCT scans showing only single jaw.
- CBCT scans completely edentulous people.
- Teeth with incomplete root development are excluded.
- Teeth with unclear alveolar crest around it due to metallic artifacts from nearby restoration.
- Presence of large pathological lesions.
- Fractured teeth or alveolar process.
- Sources: CBCT images will be obtained from patient's database at the Department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University. **Methods of selection: The sample will be selected by random manual means from database of Promax 3D Mid machine. **Bias: Investigators are going to be blinded about patients' age and gender prior to scans interpretation.
- Blinding/Masking: After recruitment of images, a volunteering radiologist will perform coding of the images and clinical data. All investigators will be blinded of the data collected. The main investigator will evaluate the images twice with two weeks interval between the two reading sessions, while second investigator will evaluate it once. Inter-observational and intra-observational variability between the observers will be statistically evaluated.
- Statistical Considerations: SAMPLE SIZE ESTIMATION This study is designed to determine the frequency of root fenestration and dehiscence at different teeth types in a sample of adult Egyptian population using CBCT. Based on previous study by Enhos et al (2012)13, Buyuk et al (2016) 21 and Gambarini et al (2017)15, the weighted average expected frequency of fenestration and dehiscence of the three studies are 7.0 % for fenestration and 4.8 % for dehiscence. A total sample size of 100 cases will be needed to provide a two-sided 95% confidence interval for a single proportion using the large sample normal approximation and will extend 5% from the observed proportion for an expected proportion of 0.07. Sample size estimation was performed by Epi info statistical package. STATISTICAL METHODS Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 23 (SPSS Inc., Chicago, IL). The estimation of the frequency of fenestration and dehiscence in a sample of the adult Egyptian population will be described as numbers and percentages. The 95% confidence intervals for all estimates will be calculated
- Conditions
- Root Fenestation and Dehiscence
- Keywords
- frequency fenesration dehiscence cbct population
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Frequency of Root Fenestration and Dehiscence at Different Teeth Types in a Sample of Adult Egyptian Population Using Cone Beam Computed Tomography.
measuring device isCBCT machine, Planmeca Promax 3D Mid (Finland). unit is percentage %
Measured: 2016 2017 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study startJul 2018 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Fenestation and DehiscenceStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Nashwa Salah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471715
- Sponsor's protocol ID
- RAD 1:6:2
- Status last verified
- Mar 2018
- First submitted
- 14 Mar 2018
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Frequency of Root Fenestration and Dehiscence at Different Teeth Types in a Sample of Adult Egyptian Population Using Cone Beam Computed Tomography.
- ClinicalTrials.gov ID
- NCT03471715
- Acronym / sponsor ID
- RAD 1:6:2
- Conditions
- Root Fenestation and Dehiscence
- Keywords
- frequency fenesration dehiscence cbct population
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 21 Mar 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.
observational crosssectional study to evaluate the Frequency of Root Fenestration and Dehiscence at Different Teeth Types in a Sample of Adult Egyptian Population Using Cone Beam Computed Tomography.
Detailed description
**Data Collection:
The following data of the current retrospective study will be collected from the recruited CBCT images:-
- Demographic data: Age and Sex will be drawn from the patients' CBCT files.
- Variables: Outcome: Frequency of root fenestration and dehiscence at different teeth types in adult Egyptian population sample using CBCT. Radiographic examination was done at the Oral and Maxillofacial Radiology Department, Faculty of Dentistry, Cairo University using CBCT machine, Planmeca Promax 3D Mid (Finland) . Root fenestration (RF) will be identified according to the definition of Davies et al. 19 and the American Association of Endodontists 20 as a tooth root protruding from a window-like opening or a defect in the alveolar bone without involvement of the alveolar margin. Three points should be emphasized in this definition. 1- A window-like opening or defect of the alveolar bone means that both the cortical bone and the cancellous bone are penetrated simultaneously, and the root either is in direct contact with the overlying mucosa or exposed to the oral environment. 2- The exposed root protrudes beyond the bone. 3- The exclusion of the alveolar margin emphasized to differentiate fenestration from dehiscence. While dehiscence will be identified as the crest of buccal and lingual bone that lies at least 4mm apical to the crest of interproximal bone. The identification and measurements of the alveolar bone level will be made on CBCT cross sectional images that are corrected to be with the long axis of each tooth under examination. All assessment will be done by two examiners to eliminate the inter-examiner error. All data regarding patient identification will be kept confidential. **Participants: Eligibility criteria
- Inclusion criteria:
- CBCT scans of Adult Egyptian population with age range from 18 to 60 years old.
- The CBCT scans should fully show both maxillary and mandibular teeth with the surrounding alveolar bone.
- Permanent teeth with complete development of roots only are included.
- CBCT scans for both partially and fully dentated people are included.
- Lack of large pathological lesion.
- Lack of fracture either in teeth or alveolar bone.
- Exclusion criteria:
- CBCT scans of People younger than 18 or older than 60 years old.
- CBCT scans showing only single jaw.
- CBCT scans completely edentulous people.
- Teeth with incomplete root development are excluded.
- Teeth with unclear alveolar crest around it due to metallic artifacts from nearby restoration.
- Presence of large pathological lesions.
- Fractured teeth or alveolar process.
- Sources: CBCT images will be obtained from patient's database at the Department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University. **Methods of selection: The sample will be selected by random manual means from database of Promax 3D Mid machine. **Bias: Investigators are going to be blinded about patients' age and gender prior to scans interpretation.
- Blinding/Masking: After recruitment of images, a volunteering radiologist will perform coding of the images and clinical data. All investigators will be blinded of the data collected. The main investigator will evaluate the images twice with two weeks interval between the two reading sessions, while second investigator will evaluate it once. Inter-observational and intra-observational variability between the observers will be statistically evaluated.
- Statistical Considerations: SAMPLE SIZE ESTIMATION This study is designed to determine the frequency of root fenestration and dehiscence at different teeth types in a sample of adult Egyptian population using CBCT. Based on previous study by Enhos et al (2012)13, Buyuk et al (2016) 21 and Gambarini et al (2017)15, the weighted average expected frequency of fenestration and dehiscence of the three studies are 7.0 % for fenestration and 4.8 % for dehiscence. A total sample size of 100 cases will be needed to provide a two-sided 95% confidence interval for a single proportion using the large sample normal approximation and will extend 5% from the observed proportion for an expected proportion of 0.07. Sample size estimation was performed by Epi info statistical package. STATISTICAL METHODS Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 23 (SPSS Inc., Chicago, IL). The estimation of the frequency of fenestration and dehiscence in a sample of the adult Egyptian population will be described as numbers and percentages. The 95% confidence intervals for all estimates will be calculated
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Egyptian population
Key inclusion criteria (3 listed)
- a- CBCT scans of Adult Egyptian population with age range from 18 to 60 years old.
- b- The CBCT scans should fully show both maxillary and mandibular teeth with the surrounding alveolar bone.
- c- Permanent teeth with complete development of roots only are included. d- CBCT scans for both partially and fully dentated people are included. e- Lack of large pathological lesion. f- Lack of fracture either in teeth or alveolar bone.
Key exclusion criteria (8 listed)
- CBCT scans of People younger than 18 or older than 60 years old.
- CBCT scans showing only single jaw.
- CBCT scans completely edentulous people.
- Teeth with incomplete root development are excluded.
- Teeth with unclear alveolar crest around it due to metallic artifacts from nearby restoration.
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
Evaluation of Frequency of Root Fenestration and Dehiscence at Different Teeth Types in a Sample of Adult Egyptian Population Using Cone Beam Computed Tomography.
Time frame: 2016 2017 2018
measuring device isCBCT machine, Planmeca Promax 3D Mid (Finland). unit is percentage %
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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 Root Fenestation and Dehiscence, 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 3 inclusion and 8 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 22 Mar 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?
Evaluation of Frequency of Root Fenestration and Dehiscence at Different Teeth Types in a Sample of Adult Egyptian Population Using Cone Beam Computed Tomography. (time frame: 2016 2017 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 22 Mar 2018.