Clinical and Histological Evaluation of Deproteinizated Bovine Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift.

Not Applicable

Completed

• Conditions: Maxillary Sinus Floor Augmentation
• Interventions: Device: 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)

• Registration Number: NCT02865590
• Lead Sponsor: University of L'Aquila

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2015-10-03
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-12
• Results First Submitted: 2020-02-20
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-07
• Last Update Submitted: 2020-03-07
• Results First Posted: 2020-03-23
• Last Update Posted: 2020-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lyophilized Equine Bone Allograft	sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy)	Sinus Lift with Lyophilized Equine Bone Allograft
deproteinized bovine bone allograft	Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)	Sinus lift with deproteinized bovine bone allograft

Primary Outcome Measures

Name	Time	Method
Histomorphometric Evaluation of New Bone Formation.	6 months