Comparing 3D Printed Splints to Traditional Methods for Cheekbone Fractures Treatment: Which Works Better?

Comparative Analysis of 3D Printed Reduction Splints vs Conventional Methods in Zygomaticomaxillary Complex Fractures: Assessing Anatomical Reduction and Clinical Outcomes - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/071583

Enrollment

Registered

2024-07-30

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Application of a 3D printed reduction splint fabricated through virtual surgical planning for Zygomaticomaxillary Complex Fracture reduction: NCCT of the patient is collected and conve

Eligibility

Inclusion criteria

Inclusion criteria: i. Patients diagnosed with unilateral Zygomaticomaxillary Complex (ZMC) fractures confirmed through clinical examination and imaging (CT scans). ii. Adults aged 15 to 65 years. iii. Willingness to provide informed consent for participation in the study. iv. Patients within 1 month from the occurrence of ZMC fracture v. Absence of prior history of zygomaticomaxillary complex fractures.

Exclusion criteria

Exclusion criteria: i. Patients with bilateral Zygomaticomaxillary Complex fractures. ii. Inability or unwillingness to complywith studyrequirements, including scheduled follow-up visits. iii. Pregnant individuals due to potential risks associated with imaging procedures and treatment iv. Inability to understand or communicate effectively in the language used for study assessments. v. Severe medical conditions that may impact the ability to undergo surgery or participate in the study. vi. Syndromes with malar involvement: Eg., Malar hypoplasia in Treacher-Collins Syndrome

Design outcomes

Primary

Measure	Time frame
Precision of anatomical reduction assessed by radiographs, measuring orbital volume and linear dimensions. Timepoint: Preoperatively, Immediate post operatively, One week post operatively, One month post operatively and Three months post operatively	—

Secondary

Measure	Time frame
1. Facialsymmetry and aesthetic outcomes assessed through clinical photography in both frontal and supracranial oblique view. 2. Patient’s satisfaction in terms of facial aesthetics by means of aesthetic severity score. 3. Time taken for reduction of the fractureTimepoint: preoperative assessment, immediate postoperative assessment and late post operative assessment;1. Facialsymmetry and aesthetic outcomes assessed through clinical photography in both frontal and supracranial oblique view. 2. Patient’s satisfaction in terms of facial aesthetics by means of aesthetic severity score. 3. Time taken for reduction of the fractureTimepoint: preoperative assessment, immediate postoperative assessment and late post operative assessment	—

Measure

Time frame

1. Facialsymmetry and aesthetic outcomes assessed through clinical photography in both frontal and supracranial oblique view. 2. Patient’s satisfaction in terms of facial aesthetics by means of aesthetic severity score. 3. Time taken for reduction of the fractureTimepoint: preoperative assessment, immediate postoperative assessment and late post operative assessment;1. Facialsymmetry and aesthetic outcomes assessed through clinical photography in both frontal and supracranial oblique view. 2. Patient’s satisfaction in terms of facial aesthetics by means of aesthetic severity score. 3. Time taken for reduction of the fractureTimepoint: preoperative assessment, immediate postoperative assessment and late post operative assessment

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Countries

India

Contacts

Public ContactPOOJALEKSHMI M B

ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR

santhosh@aiimsraipur.edu.in9981525599

Outcome results

None listed

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