Digital vs. Analog Inputs in CAD/CAM Orthodontics: A Comparative Clinical Evaluation of Palatal Expander Fabrication Workflow

NCT07338591 | Not Yet Recruiting

• 1 other identifier: MD.25.06.22
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

36 patients with unilateral or bilateral cross bite treated with hyrax expanders fabricated through three distinct workflows: fully conventional (physical impression + manual fabrication), hybrid (physical impression + CAD/CAM fabrication), and fully digital (intraoral scanning + CAD/CAM fabrication). To evaluate and compare the clinical fit, workflow efficiency, and patient/clinician satisfaction of palatal expanders fabricated using traditional, hybrid digital, and fully digital workflows.

Conditions

Transverse Maxillary Deficiency

Keywords

Palatal Expander; Hyrax Expander; CAD/CAM Orthodontics; Digital Workflow; Intraoral Scanning

Outcome Measures

Primary Outcomes (1)

• Clinical Fit and accuracy of expander

  For the clinical fit of the palatal expander at delivery, a 5-point Likert scale could be used by the clinician as follows: Score Description 1. Very poor fit - Significant rocking or instability; requires remake 2. Poor fit - Major adjustment required (e.g., soldering, bending) 3. Acceptable fit - Minor chairside adjustments needed 4. Good fit - Minimal adjustment required 5. Excellent fit - No adjustment needed, passive and accurate seating

  Immediately after appliance insertion

Secondary Outcomes (1)

• Workflow and Chairside adjustment time

  Immediately after appliance insertion

Other Outcomes (1)

• Expansion Efficacy

  Through study completion, up to 3 months

Study Arms (3)

Fully Analogue Workflow

* Input: Physical impression. * Model: Poured in dental stone to produce physical model. * Fabrication: Hyrax expander fabricated manually by soldering/brazing components directly on the plaster cast using traditional laboratory techniques.

Hybrid Workflow

* Input: Physical impression * Model: Poured in dental stone to produce physical model. * Digitization: Desktop scanning of physical model * Fabrication: CAD-designed and 3D-printed appliance (Hyrax-type),

Fully Digital Workflow

* Input: Intraoral scan (IOS) using an optical scanner * Model: Virtual model used directly in design software. * Fabrication: CAD-designed and 3D-printed appliance (Hyrax-type),

Eligibility Criteria

• Age: 8 Months - 13 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

A total of 36 participants will be selected from outpatient clinic of orthodontics department (Faculty of Dentistry - Mansoura University). Written consent will be obtained from all legal guardians prior to enrollment.

You may qualify if:

• Aged between 8 and 13 years with transverse maxillary deficiency ( with unilateral or bilateral crossbite ,with or without anterior cross bite)
• Indicated for tooth-borne maxillary expansion
• Good oral hygiene and cooperative behavior
• No prior orthodontic treatment

You may not qualify if:

• Craniofacial anomalies or syndromes
• Requirement for surgically assisted expansion
• Poor oral hygiene or high caries index

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (2)

faculty of dentistry , Mansoura university

Al Mansurah, 35516, Egypt

Location

faculty of dentistry , Mansoura university

Al Mansurah, Egypt

Location

Central Study Contacts

samar essam saleh, master of orthodontics

CONTACT

00201093916939; samaressam700@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 14, 2026
• Study Start: December 25, 2025
• Primary Completion (Estimated): January 25, 2027
• Study Completion (Estimated): July 25, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 3 years
• Access Criteria: by request

Locations

EG (2)