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Status unknownNCT03981367Updated Jun 10, 2019

Frequency of External Root Resorption in Mandibular Second Molars Associated With Mandibular Impacted Third Molars Using CBCT

An observational study in Root Resorption and Distal Caries, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-10.

Sponsored by Cairo University · Observational

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
255
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

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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.
  1. 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.

02

Conditions studied

  • Root Resorption
  • Distal Caries

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Keywords

  • External root resorption
  • Distal caries
  • Mandibular third molar
  • Mandibular second molar
  • Cone beam computed tomography
03

In context

Root Resorption

43 studies on the registry are indexed under Root Resorption; 9 are open to participants now.

Browse Root Resorption studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Egyptian population

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The patient should be older than 18 years old.
  • Having all teeth erupted except the third molar.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
255 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  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)

    Time frame: 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 )

    Time frame: Up to 2020

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03981367
Lead sponsor
Cairo University
Responsible party
Rawan Abdel Wahhab Bahaa Eldin Elkassas (Principal Investigator, Cairo University) — Principal investigator
First posted
Jun 10, 2019
Start date
Jun 2019 (estimated)
Primary completion
Jun 2020 (estimated)
Completion
Jul 2020 (estimated)
Last update
Jun 10, 2019

Study contacts

Elkassas
Contact
rawan.elkassas@dentistry.cu.edu.eg
+02 01011385738

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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