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Comparison Of 3D plating using 3D printing with 3D plating without use of 3D printing in mandibular fracture

Comparison Of Pre-adjusted 3D Plating System Employing 3D Printing Verses Conventional 3D Plating In The Management Of Mandibular Fractures â?? A Controlled Prospective Double Blind Study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025916
Enrollment
20
Registered
2020-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: T79- Certain early complications of trauma, not elsewhere classified

Interventions

Intervention1: Open reduction and internal fixation using preadjusted 3D plate for the management mandibular fractures: 3D plated preadjusted pre operatively on 3D stereolithographic modes which are m

Sponsors

Ashish Sarda
Lead Sponsor
Dr Prajwalit Kende
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients who are willing to participate in the study. 2) Patients with no significant medical history. 3) Patients with unilateral and/or bilateral fracture present on symphyses, parasymphyses or angle of mandible region. 4) Patients having favourable fractures and willing for open reduction and internal fixation 5) Patient with fracture in the body of mandible region where 3D miniplate can be applied & where vital structures will not cause any interference.

Exclusion criteria

Exclusion criteria: 1) Patients not willing for participation in the study 2) Patient having history of any systemic diseases. 3) Pregnant and lactating patient. 4) Patients with condylar/subcondylar/coronoid fractures. 5) Patients with fracture in body of mandible where 3D plate can not be applied due to vital structures. 6) Patients present with severe comminuted fractures. 7) Patients with fractures presenting with severe soft tissue loss. 8) Patient not willing for open reduction. 9) Patients with craniomaxillofacial fractures.

Design outcomes

Primary

MeasureTime frame
1. Number of bends required for adaptation of 3D plates (measured by counting) 2. Time required for plating (minutes and seconds) 3. Pain during adaptation of 3D plate 4. Occlusal stability 5. Amount of reduction of lingual splay 6. Postoperative complications 7. Cost effectiveness. Timepoint: 3, 6 and 12 month follow up

Secondary

MeasureTime frame
1. Pain during adaptation of 3D plate 2. Occlusal stability 3. Amount of reduction of lingual splay 4. Postoperative complications 5. Cost effectiveness. Timepoint: 1. immedaitely 2. 3rd day, 7th day, 3 months, 6 months, 1 year 3. 3rd day, 7th day, 3 months, 6 months, 1 year 4. 3 months, 6 months, 1 year 5. 3 months, 6 months.

Countries

India

Contacts

Public ContactAshish Sarda

Government Dental College and Hospital, Mumbai

prajwalitkende1979@gmail.com9324715824

Outcome results

None listed

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