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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-13
SponsorMansoura University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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

Disqualifiers

• Craniofacial anomalies or syndromes

Requirement for surgically assisted expansion

Poor oral hygiene or high caries index

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

36 Participants
are grouped into 3 trial groups
Group A: Fully Analogue Workflow
Group B: Hybrid Workflow
Group C: Fully Digital Workflow

Trial outcomes

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

Time frame
Immediately after appliance insertion

Secondary outcomes

1

Workflow and Chairside adjustment time

Time measured in minutes from impression to appliance delivery

Time frame
Immediately after appliance insertion

Other outcomes

1

Expansion Efficacy

Measurement Method: Transverse dental arch width (mm) at canines / premolars / molars (digital calipers on casts/scans) and Arch length.

Time frame
Through study completion, up to 3 months

Sponsors and contacts

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