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Designing of a new fixation device for lower jaw and compare the efficacy with conventional fixation device.

Design development,Biomechanical validation and Clinical evaluation of a novel miniplate design for Mandible angle fracture management:Two phase study - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083522
Enrollment
28
Registered
2025-03-26
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: S026- Fracture of mandible

Interventions

Intervention1: Group B New design miniplate fixation group: Stage 1 It will be done using computational mandible models & Polyurethrane mandible. Angle fracture will be fixed with new design miniplate

Sponsors

sinhgad dental college and hospital Pune
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with Mandible angle fracture. 2. Patients of age group 18-60yrs 3. Patient under ASA I & ASA II

Exclusion criteria

Exclusion criteria: 1.Patients with comminuted fracture at angle region. 2. Patients under ASA III & ASA IV 3. Patients with gross infection. 4.Patients who are not fit for surgery. 5. Oral submucous fibrosis patients(OSMF) 6. Patient who is not willing to participate

Design outcomes

Primary

MeasureTime frame
evaluate and compare new design miniplate efficacy biomechanically and clinically.Timepoint: 4year—

Secondary

MeasureTime frame
To validate and compare the biomechanical behaviour of new miniplate system with conventional system. stage II To evaluate and compare the treatment outcome of new miniplate system with conventional miniplate system. To evaluate and compare the functional stability of new miniplate fixation with conventional miniplate system. Timepoint: 2year—

Countries

India

Contacts

Public ContactDr RK Suryavanshi

Sinhgad Dental college and hospital Pune

oralsurgery.sdch@sinhgad.edu9922994797

Outcome results

None listed

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