Frequency of Root Fenestration and Dehiscence in Adult Egyptian Population Using CBCT.

March 20, 2018 updated by: Prof. Nashwa Salah, Cairo University

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.

Study Overview

Status

Unknown

Detailed Description

**Data Collection:

The following data of the current retrospective study will be collected from the recruited CBCT images:-

  1. Demographic data:

    Age and Sex will be drawn from the patients' CBCT files.

  2. 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

    1. 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.
    2. 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 Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Egyptian population

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. CBCT scans of People younger than 18 or older than 60 years old.
  2. CBCT scans showing only single jaw.
  3. CBCT scans completely edentulous people.
  4. Teeth with incomplete root development are excluded.
  5. Teeth with unclear alveolar crest around it due to metallic artifacts from nearby restoration.
  6. Presence of large pathological lesions.
  7. Fractured teeth or alveolar process.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 %
2016 2017 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2018

Primary Completion (ANTICIPATED)

August 1, 2018

Study Completion (ANTICIPATED)

August 1, 2018

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (ACTUAL)

March 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • RAD 1:6:2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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