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Comparing three types of custom-made skull implants (Titanium, PMMA, PEEK) in patients with head injury to assess recovery and complications after surgery

Evaluation of comparative clinical efficacy of digitally fabricated cranial implants made from ultra-high- molecular weight polyethylene and titanium implants in post-traumatic brain injury patients undergoing cranioplasty- A randomized control trial. - NIL

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/098200
Enrollment
30
Registered
2025-11-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: S02- Fracture of skull and facial bones

Interventions

Intervention1: cranioplasty with Titanium: This involves the surgical repair or reconstruction of skull defects using titanium as the implant material. These defects can result from trauma, decompress

Sponsors

Institutional funding Sharad Pawar Dental College and Hospital DMIHER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 to 45 years who have cranial defect larger than 3 cm in diameter; resulting from traumatic brain injury and require cranioplasty. No previous history of infection at the site designated for cranioplasty. Patients with stable medical conditions and no contraindications for surgery or the materials used. Patients who are willing to participate in the study and provide informed consent.

Exclusion criteria

Exclusion criteria: 1 Patients unfit for cranioplasty 2 Patients presenting with infection before cranioplasty 3 Patients with prior cranial surgeries using non-customized implants.

Design outcomes

Primary

MeasureTime frame
surgical site infection requiring implant removal or revision, implant exposure or wound breakdown requiring surgical intervention, clinically significant graft/implant resorption or structural failure necessitating revision surgery.Timepoint: 3months

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Akansha Bansod

Sharad Pawar Dental College and Hospital,

drsweta15@gmail.com7000626186

Outcome results

None listed

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