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

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.

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Key information

Conditions

Maxillary Sinus Floor Augmentation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

Histomorphometric Evaluation of New Bone Formation.

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of L'Aquila

Other

Registry information

Official study title

Clinical and Histological Evaluation of Demineralized Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift: Double Blind, Parallel, Randomized Clinical Trial.

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Aug 12, 2016
Registry last updated: Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed