Clinical trial · Interventional
Application of CAD-CAM Technology in Orbital Bone Reconstruction
Comparison of Two Different Modalities for Orbital Reconstruction Based on CAD-CAM Technology: A Clinical Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Reconstruction of orbital defects resulting after trauma; tumor resection; maxillary cyst; craniofacial anomalies and sequestrated bone…. etc., has been a challenging issue over the years and this owing to the complicated anatomy of orbit. Inaccurate orbital reconstruction may lead to devastating cosmetic and functional complications. Titanium mesh for orbital reconstruction has now become "probably" the most popular material for orbital wall reconstruction worldwide. Innovation of CAD-CAM technology and its application in maxillofacial surgery will markedly improve the surgical outcome. This study will assess the accuracy of orbital reconstruction using CAD-CAM technology and to compare two different modalities for orbital reconstruction based on this technology.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Facial Deformity | — | UNRESOLVED | — |
| Maxillary Cyst | — | UNRESOLVED | — |
| Maxillary Neoplasms | — | UNRESOLVED | — |
| Orbital Bone Fracture | — | UNRESOLVED | — |
| Orbital Neoplasms | Orbital Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Zygomatic Fractures | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| orbital bone reconstruction with patient specific titanium implant | Procedure | — | UNRESOLVED |
| orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A (patient specific titanium implant)
- description
- (reconstruction with patient specific titanium implant)
- interventionNames
- Procedure: orbital bone reconstruction with patient specific titanium implant
- type
- ACTIVE_COMPARATOR
- label
- Group B (preformed plate bended on stereolithographic model)
- description
- (reconstruction with preformed titanium plate preoperatively bended on stereolithographic model)
- interventionNames
- Procedure: orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model
Primary outcomes (1)
- measure
- measurement of Changes in orbital bony volume
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * fracture of the orbital floor and/or medial wall and/or lateral wall. * complex fracture of the zygomatic bone (those affecting orbital volume). * Old orbital fractures on either side causing enophthalmos, diplopia, cosmetic asymmetry. * Periorbital neoplasm affecting orbital volume and need surgical resection Exclusion Criteria: * injury to the globe that restricts surgical reconstruction. * neurological diseases with influence on eye motility or sight. * Patients with special needs. * Medically compromised patients who are not fit for surgery. * Patients refused participation in this study.
References
Publications (9)
- BACKGROUNDAbbate V, Iaconetta G, Califano L, Pansini A, Bonavolonta P, Romano A, Salzano G, Somma T, D'Andrea L, Dell'Aversana Orabona G. Self-Made Rapid Prototyping Technique for Orbital Floor Reconstruction: Showcases for Technical Description. J Craniofac Surg. 2019 Oct;30(7):2106-2110. doi: 10.1097/SCS.0000000000006004. PMID 31513039
- BACKGROUNDZimmerer RM, Ellis E 3rd, Aniceto GS, Schramm A, Wagner ME, Grant MP, Cornelius CP, Strong EB, Rana M, Chye LT, Calle AR, Wilde F, Perez D, Tavassol F, Bittermann G, Mahoney NR, Alamillos MR, Basic J, Dittmann J, Rasse M, Gellrich NC. A prospective multicenter study to compare the precision of posttraumatic internal orbital reconstruction with standard preformed and individualized orbital implants. J Craniomaxillofac Surg. 2016 Sep;44(9):1485-97. doi: 10.1016/j.jcms.2016.07.014. Epub 2016 Jul 21. PMID 27519662
- BACKGROUNDFelding UNA. Blowout fractures - clinic, imaging and applied anatomy of the orbit. Dan Med J. 2018 Mar;65(3):B5459. PMID 29510812
- BACKGROUNDMustafa SF, Evans PL, Bocca A, Patton DW, Sugar AW, Baxter PW. Customized titanium reconstruction of post-traumatic orbital wall defects: a review of 22 cases. Int J Oral Maxillofac Surg. 2011 Dec;40(12):1357-62. doi: 10.1016/j.ijom.2011.04.020. Epub 2011 Aug 31. PMID 21885249
- BACKGROUNDRaisian S, Fallahi HR, Khiabani KS, Heidarizadeh M, Azdoo S. Customized Titanium Mesh Based on the 3D Printed Model vs. Manual Intraoperative Bending of Titanium Mesh for Reconstructing of Orbital Bone Fracture: A Randomized Clinical Trial. Rev Recent Clin Trials. 2017;12(3):154-158. doi: 10.2174/1574887112666170821165206. PMID 28828975
- BACKGROUNDSugar AW, Kuriakose M, Walshaw ND. Titanium mesh in orbital wall reconstruction. Int J Oral Maxillofac Surg. 1992 Jun;21(3):140-4. doi: 10.1016/s0901-5027(05)80780-5. PMID 1640125
- Bly RA, Chang SH, Cudejkova M, Liu JJ, Moe KS. Computer-guided orbital reconstruction to improve outcomes. JAMA Facial Plast Surg. 2013 Mar 1;15(2):113-20. doi: 10.1001/jamafacial.2013.316.