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Comparison of the fit of polymer based prosthetic skull bone made using traditional and digital approach

Comparative evaluation of the accuracy of polymethyl methacrylate (PMMA) cranioplasts made using conventional and hybrid workflows. A prospective clinical study - NIL

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089196
Enrollment
12
Registered
2025-06-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z972- Presence of dental prosthetic device (complete) (partial)

Interventions

Intervention1: DigitalApproach: PMMA cranioplast fabricated using the hybrid workflow techniques that involves the use of CT as a substitute of conventional impression of defect area Control Intervent

Sponsors

Maulana Azad Institute of Dental Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Medically stable patients referred for cranioplast fabrication by the treating neurosurgeon

Exclusion criteria

Exclusion criteria: Patients or legal representatives unwilling to provide consent Patients with existing cranial implants interfering with accuracy assessment Patients with active cranial infections or non-healing wounds at the defect site

Design outcomes

Primary

MeasureTime frame
Accuracy of PMMA Cranioplasts evaluated using software-based 3D comparison of STL files from extraoral scans and neurosurgeon feedback based on clinical fit, adjustments required, and preference using a Likert scale. Patient Comfort and Preference will also be evaluated using a feedback questionnaire.Timepoint: Accuracy of PMMA Cranioplasts: Evaluated using software-based 3D comparison of STL files from extraoral scans. Neurosurgeon Feedback: Based on clinical fit, adjustments required, and preference using a Likert scale. Patient Comfort and Preference: Evaluated using a feedback questionnaire Ease of Intraoperative Adjustments: Recorded by the operating neurosurgeon

Secondary

MeasureTime frame
NILTimepoint: Nil

Countries

India

Contacts

Public ContactDr Rinku

Maulana Azad Institute of Dental Sciences

dr_rekhagupta@yahoo.co.in9654700952

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026