Comparing 3D Printed Splints to Traditional Methods for Cheekbone Fractures Treatment: Which Works Better?
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2024/07/071583
- Lead Sponsor
- Dr Poojalekshmi M B
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Precision of anatomical reduction assessed by radiographs, measuring orbital <br/ ><br>volume and linear dimensions. <br/ ><br>Timepoint: Preoperatively, Immediate post operatively, One week post operatively, One month post operatively and Three months post operatively <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Facialsymmetry and aesthetic outcomes assessed through clinical photography <br/ ><br>in both frontal and supracranial oblique view. <br/ ><br>2. Patient’s satisfaction in terms of facial aesthetics by means of aesthetic severity <br/ ><br>score. <br/ ><br>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 <br/ ><br>in both frontal and supracranial oblique view. <br/ ><br>2. Patient’s satisfaction in terms of facial aesthetics by means of aesthetic severity <br/ ><br>score. <br/ ><br>3. Time taken for reduction of the fractureTimepoint: preoperative assessment, immediate postoperative assessment and late post operative assessment