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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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:

  1. Angulation of the third molar according to Winter's classification (vertical/mesio-angular/disto-angular/horizontal).
  2. Position of impacted mandibular third molar according to Pell and Gregory21 classification. (Position A, position B, position C)
  3. Age.
  4. Gender.
  5. 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.

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.

  1. 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)
  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.

  1. First posted10 Jun 2019
  2. Study startJun 2019 (estimated)
  3. Primary completionJun 2020 (estimated)
  4. Study completionJul 2020 (estimated)

Resources

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)
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

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.

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