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A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management

Maxillofacial Injuries Clinical Trial

Official title:
A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management

Clinical Trial Summary

The study is a blind randomized clinical study on patients with midface maxillofacial fractures coming to Cipto Mangunkusumo Hospital. The subject is the fracture line who met the inclusion criteria and randomly allocated into the study (locally-made miniplate and screw) and control (BIOMET® miniplate and screw) group through a predetermined randomization list. The healing process is follow up using non-contrast head computed tomography immediately after surgery as a baseline, and 3 months post-op. Afterward, a radiologist consultant as a blinded evaluator will evaluate the score of bone density, and screw loosening, while local tissue reaction after fixation evaluates during the patient's visit outpatient clinic. All scores from points of the evaluation group will be collected and going to statistically evaluated using independent t-test or Mann Whitney test depending on the distribution of the data

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04279925
Study type Interventional
Source Indonesia University
Contact
Status Terminated
Phase N/A
Start date March 11, 2020
Completion date May 31, 2020
View Details
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