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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2015

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)

Arms, Groups and Cohorts

  • Experimental: Lyophilized Equine Bone Allograft
    • Sinus Lift with Lyophilized Equine Bone Allograft
  • Active Comparator: deproteinized bovine bone allograft
    • Sinus lift with deproteinized bovine bone allograft

Clinical Trial Outcome Measures

Primary Measures

  • Histomorphometric Evaluation of New Bone Formation.
    • Time Frame: 6 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of L’Aquila
  • Provider of Information About this Clinical Study
    • Principal Investigator: Enrico Marchetti, assistant professor – University of L’Aquila
  • Overall Official(s)
    • GIUSEPPE MARZO, DMD, Study Chair, University of L’Aquila

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