Clinical and Histological Evaluation of Deproteinizated Bovine Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift.
1 other identifier
interventional
16
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2011
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 3, 2015
CompletedFirst Posted
Study publicly available on registry
August 12, 2016
CompletedResults Posted
Study results publicly available
March 23, 2020
CompletedMarch 23, 2020
March 1, 2020
4.3 years
October 3, 2015
February 20, 2020
March 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Histomorphometric Evaluation of New Bone Formation.
6 months
Study Arms (2)
Lyophilized Equine Bone Allograft
EXPERIMENTALSinus Lift with Lyophilized Equine Bone Allograft
deproteinized bovine bone allograft
ACTIVE COMPARATORSinus lift with deproteinized bovine bone allograft
Interventions
Eligibility Criteria
You may qualify if:
- bilateral atrophy of the maxilla;
- bone ridge \<= 6mm
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Results Point of Contact
- Title
- Enrico Marchetti DDS, PhD
- Organization
- Department MESVA - University of L'Aquila
Study Officials
- STUDY CHAIR
GIUSEPPE MARZO, DMD
University of L'Aquila
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
October 3, 2015
First Posted
August 12, 2016
Study Start
June 1, 2011
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
March 23, 2020
Results First Posted
March 23, 2020
Record last verified: 2020-03