Last reviewed · How we verify
NCT04257097
Reinforced PTFE Meshes Versus Customized Titanium Meshes
NA trial testing RPM - Osteogenics Lubbock Texas USA in Surgical Procedure, Unspecified in 50 participants. Completed in 1 March 2025.
1 November 2022
Quick facts
| Lead sponsor | GBR Academy |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 March 2020 |
| Primary completion | 1 November 2022 |
| Estimated completion | 1 March 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- RPM - Osteogenics Lubbock Texas USA
- Yxoss CBR - Reoss Filderstadt Germany
Conditions studied
- Surgical Procedure, Unspecified — all drugs for Surgical Procedure, Unspecified →
- Soft Tissue Infections — all drugs for Soft Tissue Infections →
- Surgical Wound Dehiscence — all drugs for Surgical Wound Dehiscence →
- Bone Density — all drugs for Bone Density →
Sponsor
GBR Academy
Who can join
18 and older, any sex, with Surgical Procedure, Unspecified or Soft Tissue Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to compare two surgical techniques for the treatment of the maxillary and mandibular bone atrophies.. Therefore, the main purpose is to compare the (i) the percentage of post-operative complications (ii) the three-dimensional bone gain with customized titanium meshes (test group - the medical device is digitally designed and made with customized laser sintering modality, customized to the defect of each patient) and with titanium-reinforced PTFE mesh (control group - the medical device is cut, shaped, and manually modelled to the patient's defect by the operator himself.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Complication, vertical bone gain, volumetric changes after vertical ridge augmentation using customized reinforced PTFE mesh or Ti-mesh. A non-inferiority randomized clinical trial.
Cucchi A, Bettini S, Tedeschi L, Urban I, et al · · 2024 · cited 18× · PMID 39180274 · DOI 10.1111/clr.14350 -
Operative Times, Costs and Patient-Related Outcome Measures in Vertical Ridge Augmentation With Customised Reinforced PTFE Mesh Versus CAD/CAM Titanium Mesh: Secondary Analysis of a Randomised Clinical Trial.
Cucchi A, Bettini S, Tedeschi L, Franceschi D, et al · · 2025 · cited 3× · PMID 40419437 · DOI 10.1111/jcpe.14185
Verify or expand the search:
- PubMed search for NCT04257097
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other GBR Academy trials
Trials by the same sponsor.
- NCT04286334 — Three-dimensional Bone Regeneration Using Custom-made Meshes With and Without Collagen Membrane · NA · completed
- NCT05753917 — Piezo-surgery Versus Conventional Drills · NA · completed
- NCT04332679 — Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes · NA · completed
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 NCT04257097 (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 GBR Academy
- Last refreshed: 14 March 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/NCT04257097.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing