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

U

University of L'Aquila

Status

Completed

Conditions

Maxillary Sinus Floor Augmentation

Treatments

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)

Study type

Interventional

Funder types

Other

Identifiers

NCT02865590
Prot.001/luglio2010

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

16 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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