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

Phase 4

Completed

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

• Registration Number: CTRI/2020/06/025916
• Lead Sponsor: Ashish Sarda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-10-16
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1.Pain during adaptation of 3D plate <br/ ><br>2.Occlusal stability <br/ ><br>3. Amount of reduction of lingual splay <br/ ><br>4. Postoperative complications <br/ ><br>5. Cost effectiveness. <br/ ><br>Timepoint: 1. immedaitely <br/ ><br>2. 3rd day, 7th day, 3 months, 6 months, 1 year <br/ ><br>3. 3rd day, 7th day, 3 months, 6 months, 1 year <br/ ><br>4. 3 months, 6 months, 1 year <br/ ><br>5. 3 months, 6 months.