N/A
N=16
Clinical and Histological Evaluation of Deproteinizated Bovine Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift.
Maxillary Sinus Floor Augmentation
Bottom Line
View on ClinicalTrials.gov: NCT02865590 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Histomorphometric Evaluation of New Bone Formation. — 22.20; 22.84; 50.77; 46.20 percentage of millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy) (Device); Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of L'Aquila
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Histomorphometric Evaluation of New Bone Formation. |
22.20; 22.84; 50.77; 46.20; 27; 30.94 | — |
Summary
The sinus infiltration technique for sinus floor elevation has been used successfully when a reduced vertical height is available in the posterior maxilla. However, the effect of the different graft material on the volume and on the quality of new bone formed has not been fully investigated. The aim of this study is to evaluate the clinical and histological effect of a test material, lyophilized equine bone (Bio-gen®), compared with control material, deproteinized bovine bone (Endobon®), in the sinus lift techniques with lateral approach.
Eligibility Criteria
Inclusion Criteria
- bilateral atrophy of the maxilla;
- bone ridge <= 6mm
Exclusion Criteria
- severe systemic diseas (ASA III -IV) bisphosphonate therapy or a history of up to 3 years history of radiation therapy to neck and head area sinusitis pregnancy subjects not able to consent to participate in the study.
Data sourced from ClinicalTrials.gov (NCT02865590). 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.