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NCT06933628
Custom Titanium Plates vs. 3D Splints in LeFort I Osteotomy
NA trial testing Patient-Specific Titanium Plates in Dentofacial Deformities in 12 participants. Completed in 1 April 2025.
1 January 2025
Quick facts
| Lead sponsor | Al-Azhar University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 10 January 2023 |
| Primary completion | 1 January 2025 |
| Estimated completion | 1 April 2025 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Patient-Specific Titanium Plates
- 3D-Printed Intermediate Splint
Conditions studied
- Dentofacial Deformities — all drugs for Dentofacial Deformities →
Sponsor
Al-Azhar University
Who can join
Adults 18 to 30, any sex, with Dentofacial Deformities. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized comparative study evaluates the accuracy and feasibility of two techniques for maxillary repositioning in Le Fort I osteotomy: Customized titanium plates (splintless technique) Three-dimensional (3D)-printed intermediate splints Participants (n = 12) aged 18-30 years with dentofacial deformities will be equally divided into two groups: Group I: Osteotomy guided by patient-specific surgical guides, fixed with pre-bent customized titanium plates. Group II: Osteotomy guided by 3D-printed intermediate splints with conventional fixation. Primary Outcome Accuracy of maxillary repositioning (measured as millimeter \[mm\] deviation from the virtual surgical plan), assessed via computed tomography (CT) superimposition using Mimics software at one week postoperatively. Secondary Outcomes Operative time Fabrication accuracy of the customized titanium plate and 3D-printed splint Postoperative complications (e.g., infection, plate failure) Hypothesis Customized titanium plates will reduce maxillary positioning errors and operative time compared to 3D-printed splints. Relevance This study may validate splintless techniques for improved precision in orthognathic surgery.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Accuracy Assessment of Customized Titanium Plates Compared to 3D-Printed Splints in Le Fort I Osteotomy: A Randomized Clinical Trial Evaluating Clinical and Radiographic Outcomes.
Abdelhamid AM, Hassan AM, El-Mohandes WA. · · 2025 · PMID 40519468 · DOI 10.7759/cureus.84151
Verify or expand the search:
- PubMed search for NCT06933628
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Dentofacial Deformities
Currently open trials in the same condition.
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- NCT06806605 — Full-3D Computer-Assisted Workflow for the Diagnosis and Correction of Deformities? Dentofacial · recruiting
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Other Al-Azhar University trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06933628 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Al-Azhar University
- Last refreshed: 25 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06933628.
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