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A clinical trial to study the the New hinge-based miniplates for Maxillofacial fractures

Evaluation of the efficacy of the neoteric all-rounder Hinge plating system in maxillofacial Fractures: An in-vivo study - NILL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066791
Enrollment
19
Registered
2024-05-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: V00-Y99- External causes of morbidity

Interventions

Intervention1: All Rounder Hinge Plating System: A Maxillofacial Titanium Plating system With a novel design that enables it to be used in multiples sites of the face. The novel plate will be used to

Sponsors

Varsha S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with Complicated Maxillofacial fractures of the middle and lower one third of the face 2.Patients who are certified fit for surgery by physician (based on ASA classification) 3.Patients’ cooperative to Clinical and radiological follow up for the study duration

Exclusion criteria

Exclusion criteria: 1. Patients not fit for surgical procedures (based on ASA classification) 2. Grade 3 Atrophic mandible (based on Luhr classification) 3. Pre- traumatic Functional deficit

Design outcomes

Primary

MeasureTime frame
Fracture stability dental occlusionTimepoint: 2 weeks

Secondary

MeasureTime frame
clinical function aesthetics bone healingTimepoint: 6 months

Countries

India

Contacts

Public ContactMahesh Kumar R

Sri Siddhartha Academy of Higher Education

mahu017@gmail.com9845417365

Outcome results

None listed

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