N/A
N=15
The Horizontal Ridge Augmentation Using Equine Xenograft and a Collagenated Porcine Cortical Lamina
Horizontal Ridge Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT04376060 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Change From Baseline in Radiological Bone Width Augmentation at 0 mm — 2.274 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gen-Os®; The soft lamina (OsteoBiol®) (Device)
- Age
- Adult · 27+ yrs
- Sex
- All
- Sponsor
- Saint-Joseph University
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Radiological Bone Width Augmentation at 0 mm |
2.274 | — |
| PRIMARY Change From Baseline in Radiological Bone Width Augmentation at 2 mm |
2.274 | — |
| PRIMARY Change From Baseline in Radiological Bone Width Augmentation at 4 mm |
2.028 | — |
| PRIMARY Change From Baseline in Radiological Bone Width Augmentation at 6 mm |
1.442 | — |
| SECONDARY Number of Implants Placed at 6 Months From the Regeneration Procedure |
26 | — |
| SECONDARY Change From Baseline in Radiological Bone Height Augmentation in mm Measured Buccally |
2.776 | — |
| SECONDARY Bone Percentage Superficially |
60.781 | — |
| SECONDARY Change From Baseline in Radiological Bone Height Augmentation in mm Measured Medially |
0.812 | — |
| SECONDARY Change From Baseline in Radiological Bone Height Augmentation in mm Measured Lingually |
0.734 | — |
| SECONDARY Bone Percentage Medially |
73.616 | — |
| SECONDARY Bone Percentage in the Deep Cuts |
77.234 | — |
Summary
The primary aim of this study is to clinically, radiographically and histologically evaluate the lateral bone augmentation of the soft porcine cortical lamina (OsteoBiol®) using equine-derived bone particles (OsteoBiol®)
Eligibility Criteria
Inclusion Criteria
- systematically healthy
- good oral hygiene (FMPS and FMBS 10 cigarettes/day)
- patients needing vertical augmentations
Data sourced from ClinicalTrials.gov (NCT04376060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.