Root ResorptionNCT03981367
Frequency of External Root Resorption in Mandibular Second Molars Associated With Mandibular Impacted Third Molars Using CBCT
An observational study of Root Resorption and Distal Caries, run by Cairo University.
Trial summary
The prevalence of external root resorption and distal caries in mandibular second molars associated with impacted mandibular third molars will be detected in addition to the association of the risk factors. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Resorption, Distal Caries
- How many people
- 255 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Jul 2020
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Egyptian population
Who may be able to join
- The patient should be older than 18 years old.
- Having all teeth erupted except the third molar.
Who cannot join
- Completely erupted third molars.
- Impacted third molars with pathologic lesions.
- Third molars with evidence of root development which is less than two-thirds.
- Any artifact demonstration that obscure the areas of interest.
- Missing third molars.
- Patients with developmental disorders like microdontia, presence of fourth molars, impacted second molars, supernumerary teeth, and odontomes.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Frequency of External Root Resorption and Distal Caries in Mandibular Second Molars Associated With Mandibular Impacted Third Molars in a Sample of Egyptian Population Using CBCT: A Hospital-Based Cross-Sectional Study
The prevalence of external root resorption and distal caries in mandibular second molars associated with impacted mandibular third molars will be detected in addition to the association of the risk factors.
Read the detailed description
Settings:
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.
Variables:
- Angulation of the third molar according to Winter's classification (vertical/mesio-angular/disto-angular/horizontal).
- Position of impacted mandibular third molar according to Pell and Gregory21 classification. (Position A, position B, position C)
- Age.
- Gender.
- Data Sources / Measurements:
- Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.
- All the CBCT examinations will be scanned using CBCT Software (Planmeca Romexis Viewer).
- CBCT images will be analysed in the 3 planes; the sagittal, coronal and axial sections in the 3D module, and in the cross-sectional cuts in the dental volume reformatting module for detection of ERR and/or caries.
- A carious lesion will be considered present when radiolucency can be seen in enamel and/or dentine in any of the cuts.
- Caries will be graded according to severity into:
- Incipient (less than halfway through the enamel)
- Moderate (more than halfway through enamel but does not involve the dentino-enamel junction (DEJ)
- Advanced (to the DEJ but does not extend more than half the distance to the pulp)
- Severe (more than half the distance to the pulp)
- ERR will be diagnosed as clear loss of substance in the root of adjacent second molar teeth due to direct contact between it and impacted third molar.
- ERR will be graded according to severity into:
- ERR involving less than half the dentine thickness (slight)
- ERR involving at least half the dentine (moderate)
- ERR involving the pulp cavity (severe)
- Severity of caries and ERR will be correlated to the study variables.
- CBCT images will be interpreted by two dental radiologists with more than 7 years experience independently; blinded from demographic data of the patients and from the results of each other.
- One of the radiologists will evaluate the images 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:
Based on the previous paper by Tassoker et al.1 2018, conducted in Turkey, the prevalence of ERR was 21%. Using a precision of 5, a design effect set at 1 with 95% CI (confidence interval), a total sample size of 255 will be sufficient. The sample size was calculated by Epi info.
Quantitative Variables:
The number of CBCT scans of Egyptian individuals with ERR and/or distal caries in mandibular 2nd molars associated with mandibular 3rd molars will be counted to estimate their frequency 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. Comparisons between male and females for normally distributed numeric variables will be done using the 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 two tailed.
- Conditions
- Root Resorption, Distal Caries
- Keywords
- External root resorption, Distal caries, Mandibular third molar, Mandibular second molar, Cone beam computed tomography
- Medical subject headings
- Root Resorption
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of external root resorption (ERR) in mandibular 2nd molars in percentage
Detection of external root resorption in mandibular 2nd molars associated with mandibular impacted third molars using CBCT software Romexis, (Dichotomous data - Yes/No)
Measured: Up to 2020
Secondary outcomes (1)
Presence of distal caries in mandibular 2nd molars in percentage
Detection of distal caries in mandibular 2nd molars associated with mandibular impacted third molars using CBCT software Romexis, (Dichotomous data - Yes or No )
Measured: Up to 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study startJun 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root ResorptionStudies 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
- Cross-sectional
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rawan Abdel Wahhab Bahaa Eldin Elkassas, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981367
- Sponsor's protocol ID
- RAD2:8:11
- Status last verified
- Jun 2019
- First submitted
- 3 Jun 2019
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of External Root Resorption and Distal Caries in Mandibular Second Molars Associated With Mandibular Impacted Third Molars in a Sample of Egyptian Population Using CBCT: A Hospital-Based Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT03981367
- Acronym / sponsor ID
- RAD2:8:11
- Conditions
- Root Resorption, Distal Caries
- Keywords
- External root resorption, Distal caries, Mandibular third molar, Mandibular second molar, Cone beam computed tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 10 Jun 2019 (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.
The prevalence of external root resorption and distal caries in mandibular second molars associated with impacted mandibular third molars will be detected in addition to the association of the risk factors.
Detailed description
Settings:
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.
Variables:
- Angulation of the third molar according to Winter's classification (vertical/mesio-angular/disto-angular/horizontal).
- Position of impacted mandibular third molar according to Pell and Gregory21 classification. (Position A, position B, position C)
- Age.
- Gender.
- Data Sources / Measurements:
- Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.
- All the CBCT examinations will be scanned using CBCT Software (Planmeca Romexis Viewer).
- CBCT images will be analysed in the 3 planes; the sagittal, coronal and axial sections in the 3D module, and in the cross-sectional cuts in the dental volume reformatting module for detection of ERR and/or caries.
- A carious lesion will be considered present when radiolucency can be seen in enamel and/or dentine in any of the cuts.
- Caries will be graded according to severity into:
- Incipient (less than halfway through the enamel)
- Moderate (more than halfway through enamel but does not involve the dentino-enamel junction (DEJ)
- Advanced (to the DEJ but does not extend more than half the distance to the pulp)
- Severe (more than half the distance to the pulp)
- ERR will be diagnosed as clear loss of substance in the root of adjacent second molar teeth due to direct contact between it and impacted third molar.
- ERR will be graded according to severity into:
- ERR involving less than half the dentine thickness (slight)
- ERR involving at least half the dentine (moderate)
- ERR involving the pulp cavity (severe)
- Severity of caries and ERR will be correlated to the study variables.
- CBCT images will be interpreted by two dental radiologists with more than 7 years experience independently; blinded from demographic data of the patients and from the results of each other.
- One of the radiologists will evaluate the images 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:
Based on the previous paper by Tassoker et al.1 2018, conducted in Turkey, the prevalence of ERR was 21%. Using a precision of 5, a design effect set at 1 with 95% CI (confidence interval), a total sample size of 255 will be sufficient. The sample size was calculated by Epi info.
Quantitative Variables:
The number of CBCT scans of Egyptian individuals with ERR and/or distal caries in mandibular 2nd molars associated with mandibular 3rd molars will be counted to estimate their frequency 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. Comparisons between male and females for normally distributed numeric variables will be done using the 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 two tailed.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Egyptian population
Key inclusion criteria (2 listed)
- The patient should be older than 18 years old.
- Having all teeth erupted except the third molar.
Key exclusion criteria (6 listed)
- Completely erupted third molars.
- Impacted third molars with pathologic lesions.
- Third molars with evidence of root development which is less than two-thirds.
- Any artifact demonstration that obscure the areas of interest.
- Missing third molars.
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
Presence of external root resorption (ERR) in mandibular 2nd molars in percentage
Time frame: Up to 2020
Detection of external root resorption in mandibular 2nd molars associated with mandibular impacted third molars using CBCT software Romexis, (Dichotomous data - Yes/No)
1 secondary outcome
Presence of distal caries in mandibular 2nd molars in percentage
Time frame: Up to 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Root Resorption and Distal Caries, 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 2 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 10 Jun 2019. 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?
Contact Elkassas (+02 01011385738, rawan.elkassas@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of external root resorption (ERR) in mandibular 2nd molars in percentage (time frame: Up to 2020). 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 Jun 2019.