Diagnostic Agreement Between Clinical Assessment and CBCT... | NCT07363200

Studies
Diagnostic Agreement Between Clinical Assessment and CBCT Palatal Angle for Palatal Arch Shape

NCT07363200

Sponsor

Cairo University

Status

Not yet recruiting

Last Update Posted

Jan 27, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Morphology

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2026Estimated

Primary Completion Date

Jan 25, 2026Estimated

Completion Date

Jan 30, 2026Estimated

First Submitted Date

Jan 15, 2026

First Submission Date that Met QC Criteria

Jan 15, 2026

First Posted Date

Jan 23, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2026

Last Update Posted Date

Jan 27, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ghada Adayil, Lecturer of Oral Medicine, Periodontology, and Oral Diagnosis Faculty of Dentistry, Cairo University, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Standardized intraoral photographs corresponding to each CBCT scan will be evaluated by two calibrated examiners. Palatal arch shape will be visually classified into one of three categories: high arched palate, normal palate, or low/shallow palate. Examiners will perform assessments independently and will be blinded to CBCT measurements and to each other's results.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diagnostic agreement of palatal shape	To determine the diagnostic agreement between visual clinical classification of palatal arch shape and CBCT-derived palatal angle measurements.	January 2026

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults ≥18 years
CBCT scans showing complete hard palate
Presence of first maxillary molars bilaterally

Exclusion Criteria:

Palatal surgery or trauma history
Maxillofacial anomalies
Palatal pathology
Poor CBCT quality

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

The study included adults (≥18 years) with high-quality full-maxilla CBCT scans, excluding those with craniofacial anomalies, prior palatal surgery/trauma, palatal lesions, or poor-quality images.

Sampling Method

Probability Sample