Assessment of Mesiodistal Root Angulation Without Radiographic Guidance Versus CBCT Guidance: A Cross Sectional Study.

August 30, 2023 updated by: Kholoud Khaled Abd ElAziz, Cairo University
Digital transformation in the orthodontic field profoundly alters the way in which orthodontic treatment is perceived and delivered, moreover it aids in creating individualized orthodontic appliances.A crucial step in digital orthodontic planning in either indirect bonding or aligner treatment is localization of mesiodistal tip. Earlier, Panoramic radiographs were formerly recommended to assist clinicians in properly identifying mesiodistal root angulation. recommended to help clinician to identify mesiodistal root angulation accurately. Owens et al. recorded clinically significant variation between the radiographic and the true root angulation. Alternatively CBCT (Cone Beam Computed Tomography) guided mesiodistal root angulation assessment has superior clinical significance compared to the routinely taken panoramic radiograph . despite its accuracy ,CBCT is not justified as a part of diagnostic records for orthodontic treatment planning following the ALARA rule . To eliminate additional x ray dose Computer aided mesiodistal root angulation identification is provided by several softwares such as OrthoAnalyzer™ ,OrthoCAD® ,and SureSmile® , however, the accuracy remains questionable. These finding may point out the importance of studying the accuracy mesiodistal identification to carry on digital workflow without the radiographic guidance.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

141

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El Manial
      • Cairo, El Manial, Egypt, 35855

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with digital models and panoramic radiograph as a routine diagnostic orthodontic record before treatment.

Description

Inclusion Criteria:

  • Patients with digital models and panoramic radiograph as a routine diagnostic orthodontic record before treatment.
  • Justified CBCT record taken for impacted and ectopic teeth, planning for MARPE (mini-screw assisted rapid palatal expansion)/MSE (maxillary skeletal expansion), critical tooth movements in periodontally compromised patients, surgery first cases, taken for previous studies and other reasons.

Exclusion Criteria:

  • Severe crowding.
  • Teeth with bizarre anatomy or severely decayed.
  • Patients in mixed dentition stage.

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
Time Frame
Outcome mesiodistal Angulation: angle between dental axis created by the software according to model clinical crown and the dental long axis guided by the CBCT. (In degrees)
Time Frame: through study completion, an average of 1 year".
through study completion, an average of 1 year".

Collaborators and Investigators

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

Sponsor

Cairo University

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 (Actual)

October 21, 2022

Primary Completion (Actual)

April 21, 2023

Study Completion (Estimated)

September 21, 2023

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

August 30, 2023

First Posted (Estimated)

August 31, 2023

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 711 (Ct Surgery Network Research Group)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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