NCT07887308

Brief Summary

This retrospective cross-sectional observational study aims to develop a customized, patient-specific CBCT-based method for assessing skeletal transverse discrepancies independent of dental compensation. A total of 120 previously acquired CBCT scans of patients aged 15-30 years will be evaluated and equally divided into skeletal Class I, Class II, and Class III groups (40 scans per group). The study will assess transverse skeletal and dental relationships using standardized CBCT measurements and will evaluate the intra- and inter-examiner reproducibility of the proposed methodology. The distribution and pattern of transverse discrepancies among the three skeletal classes will also be assessed.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Sep 2026Aug 2027

Study Start

First participant enrolled

September 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

October 21, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

October 7, 2026

Last Update Submit

October 14, 2026

Conditions

Keywords

Cone-Beam Computed Tomography (CBCT) Transverse Discrepancy Dental Compensation Skeletal Malocclusion Molar InclinationCone-Beam Computed Tomography (CBCT)Transverse DiscrepancyDental CompensationSkeletal MalocclusionMolar InclinationMaxillomandibular Transverse Relationship

Outcome Measures

Primary Outcomes (1)

  • Customized Patient-Specific CBCT-Based Assessment of Skeletal Transverse Discrepancy

    Measurement of skeletal transverse discrepancy using a customized, patient-specific CBCT-based approach, independent of dental compensation.

    Baseline (at the time of CBCT acquisition)

Secondary Outcomes (1)

  • Intra- and Inter-Examiner Reproducibility of the Customized CBCT Methodology

    2 weeks

Study Arms (3)

Skeletal Class I

CBCT scans of 40 patients with a skeletal Class I sagittal relationship.

Skeletal Class II

CBCT scans of 40 patients with a skeletal Class II sagittal relationship.

Skeletal Class III

BCT scans of 40 patients with a skeletal Class III sagittal relationship.

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 15-30 years with skeletal Class I, Class II, or Class III patterns. A total of 120 previously acquired CBCT scans meeting the eligibility criteria will be retrospectively selected and equally divided into three groups: 40 Class I, 40 Class II, and 40 Class III.

You may qualify if:

  • Patients aged 15-30 years.
  • Skeletal Class I, II, or III malocclusion.
  • High-quality CBCT scans showing both the maxilla and mandible.
  • Both male and female patients.

You may not qualify if:

  • History of previous orthodontic or orthopedic treatment.
  • Craniofacial anomalies or syndromes.
  • Systemic conditions affecting craniofacial growth.
  • Severe maxillofacial pathology affecting skeletal structures.
  • Poor-quality or incomplete CBCT scans.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, MSA University

Giza, Giza Governorate, Egypt

Location

Related Publications (3)

  • Diez-Rodrigalvarez D, Bonilla-Morente E, Lopez-Jimenez AJ. A Novel Method for the Diagnosis of Transverse Maxillary Deficiencies Based on CBCT. Diagnostics (Basel). 2026 Mar 30;16(7):1034. doi: 10.3390/diagnostics16071034.

    PMID: 41975748BACKGROUND
  • Miner RM, Al Qabandi S, Rigali PH, Will LA. Cone-beam computed tomography transverse analyses. Part 2: Measures of performance. Am J Orthod Dentofacial Orthop. 2015 Aug;148(2):253-63. doi: 10.1016/j.ajodo.2015.03.027.

    PMID: 26232834BACKGROUND
  • Miner RM, Al Qabandi S, Rigali PH, Will LA. Cone-beam computed tomography transverse analysis. Part I: Normative data. Am J Orthod Dentofacial Orthop. 2012 Sep;142(3):300-7. doi: 10.1016/j.ajodo.2012.04.014.

    PMID: 22920695BACKGROUND

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2026

First Posted

October 21, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

October 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared due to confidentiality and data protection considerations.

Locations