Clinical and Histological Evaluation of Demineralized Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift: Double Blind, Parallel, Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of L'Aquila
- Enrollment
- 16
- Primary Endpoint
- Histomorphometric Evaluation of New Bone Formation.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Lyophilized Equine Bone Allograft
Sinus Lift with Lyophilized Equine Bone Allograft
Intervention: sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy) (Device)
deproteinized bovine bone allograft
Sinus lift with deproteinized bovine bone allograft
Intervention: Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy) (Device)
Outcomes
Primary Outcomes
Histomorphometric Evaluation of New Bone Formation.
Time Frame: 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Enrico Marchetti
assistant professor
University of L'Aquila