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Comparison of digitally and traditionally made artificial facial parts including eyes/ ears/nose/mid-face.

A comparative outcome evaluation of digitally and conventionally fabricated maxillofacial prosthesis: A cross -over randomized control trial. - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083181
Enrollment
24
Registered
2025-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: B465- Mucormycosis, unspecified Health Condition 2: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

Intervention1: Digitally fabricated prosthesis: Prosthesis fabricated by digital workflow using CT scan data or extra-oral facial scans obtained using facial scanner. Data obtained will be used to des

Sponsors

Post Graduate Institution Medical Education and Research Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Well healed maxillofacial defects (intra oral /extra oral/ combination of both) resulting from the surgical resection of benign and malignant tumours, infectious diseases (Mucormycosis) and trauma.

Exclusion criteria

Exclusion criteria: 1. Patients who underwent radiotherapy less than 6 months ago. 2. Maxillofacial defects due to recurrent malignancy 3. Patients not consenting for the treatment and follow-up schedule.

Design outcomes

Primary

MeasureTime frame
Quality of lifeTimepoint: Quality of life of the patients will be evaluated 1 month after delivery of digitally/conventionally fabricated prosthesis followed by buffer period of 1 week and then after 1 month of delivery of conventionally/digitally fabricated prosthesis.

Secondary

MeasureTime frame
Patient satisfactionTimepoint: 1 month post-insertion of conventional/digital prosthesis and washout period of 2 weeks

Countries

India

Contacts

Public ContactDr. Bhavita Wadhwa

PGIMER, Chandigarh

drbhavitamds@gmail.com08283827291

Outcome results

None listed

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