Trial reportBMC oral health2025
The accuracy of reconstruction of orbital wall fractures using prebent mesh versus patient specific implants: a randomized clinical trial.
Trial report in BMC oral health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06294535 (The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant : A Prospective Study
Who cites it
2 citing papers in PubMed.
- Fused filament fabrication of radiopaque barium sulfate-reinforced polyetheretherketone composites for thin-walled patient-specific orbital reconstruction.Journal of materials science. Materials in medicine · 2026Article
- Patient-specific implants for orbital fracture surgery.Taiwan journal of ophthalmologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRepairing fractures of the orbital wall and floor remains a complex challenge due to the intricate anatomy of the orbit and the limited visibility during surgery. With the advancement of digital technologies, tools such as DICOM (Digital Imaging and Communications in Medicine) now allow the creation of virtual mirrored models of the unaffected orbit, which can greatly assist in surgical planning and reconstruction. This study aimed to evaluate the accuracy of orbital wall reconstruction using patient-specific implants (PSIs) versus prebent titanium mesh. MATERIALS AND
methodsA single-blind randomized controlled clinical trial was carried out on 28 patients with unilateral orbital fractures, who were randomly divided into two equal groups. Group I underwent orbital wall reconstruction using prebent titanium mesh, while Group II received titanium PSIs. Clinical and radiographic evaluations were carried out at 1 week, 1 month, and 3 months postoperatively to evaluate enophthalmos, ocular motility, diplopia, and the precision of orbital volume restoration.
resultsThe mean postoperative orbital volume was 27.48 ± 1.324 cm³ in Group I and 25.62 ± 1.492 cm³ in Group II. The difference in orbital volume between the reconstructed and intact orbit was significantly smaller in the PSI group (0.6543 ± 0.2767 cm³) compared to the pre-bent mesh group (1.666 ± 0.3884 cm³; p < 0.05).
conclusionPatient-specific titanium implants significantly improved the accuracy of orbital volume restoration, particularly in cases involving large defects. Compared to pre-bent titanium mesh, PSIs reduced the need for revision surgery and offered superior volumetric outcomes. In contrast, prebent titanium mesh still provided satisfactory results for isolated single wall fractures and is likely to be cost-effective.
trial registrationThis trial was retrospectively registered at ClinicalTrials.gov on March 05, 2024, under the registration number NCT06294535.
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