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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06019351
Collaborator
(none)
141
1
11
12.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: OrthoAnalyzer™ software

Study Design

Study Type:
Observational
Anticipated Enrollment :
141 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Assessment of Mesiodistal Root Angulation Without Radiographic Guidance Versus CBCT Guidance: A Cross Sectional Study.
Actual Study Start Date :
Oct 21, 2022
Actual Primary Completion Date :
Apr 21, 2023
Anticipated Study Completion Date :
Sep 21, 2023

Outcome Measures

Primary Outcome Measures

  1. 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) [through study completion, an average of 1 year".]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo University Cairo El Manial Egypt 35855

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kholoud Khaled Abd ElAziz, teaching assistant, Cairo University
ClinicalTrials.gov Identifier:
NCT06019351
Other Study ID Numbers:
  • 711
First Posted:
Aug 31, 2023
Last Update Posted:
Aug 31, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 31, 2023