Comparative Study Between Lyophilized or Frozen Bone Allografts for Sinus-lifting
Primary Purpose
Disorder of Maxillary Sinus, Accessory; Bone, Bone Atrophy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
freeze bone allograft
lyophilized bone allograft
Sponsored by
About this trial
This is an interventional treatment trial for Disorder of Maxillary Sinus focused on measuring bone, maxillary sinus
Eligibility Criteria
Inclusion Criteria:
- healthy
- totally or partially edentulous patients, bilaterally, in upper premolar or molar region; presenting maxillary sinus lifting necessity with bilateral alveolar bone height lower than 5mm and indication for at least one osseointegrated dental implant in premolar or molar region.
Exclusion Criteria:
- recent sinusitis history
- hypersensibility for sinus allergens, tabagism, ethylism
- severe periodontal disease, diabetes, hypertension.
- Cases that occur schneiderian membrane perforation will be excluded from the final sample.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group lyophilized bone allograft
group freeze bone allograft
Arm Description
sinus lifting with tissue bank lyophilized bone filling
sinus lifting with freeze bone bank filling
Outcomes
Primary Outcome Measures
volume of bone neoformation in mm3
computational software for analysis the micro CT scanning of trephine bone samples images
area of bone neoformation in μm2
IMAGEJ histomorphometric software for analysis of trephine bone samples micrographic images
Secondary Outcome Measures
dental implants stability value
primary implant stability by Resonance Frequency Analysis (RFA) in ISQ
dental implants stability value
late stability by Resonance Frequency analysis (RFA) in ISQ
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02583737
Brief Title
Comparative Study Between Lyophilized or Frozen Bone Allografts for Sinus-lifting
Official Title
Histological and Microtomographic Comparative Study Between Lyophilized or Frozen Bone Allografts for Sinus-lifting: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Bone resorption and atrophy in maxillary posterior region is due to severe periodontal disease and is consequent tooth extractions. Sinus pneumatisation can occur after tooth extraction and alveolar bone loss. Consequently, bone-reducing volume at that region is a great challenge to implantodontists. Sinus lifting surgery have been practiced since 80's and many biomaterials have been used to solve filling issues to maintain the sinus floor lifted in a position that can allow dental implants installation. Bone grafts have shown to be the best choice of filling grafts. Despite autologous bone are the gold standard filling biomaterial it is associates with great mortality and morbidity. So, bone allografts from tissue bank had been shown to be an advantageous alternative. Lyophilized or freeze tissue bone are the most common allografts but literature is poor in randomized controlled parallel clinical trials regarding those filling grafts for sinus lifting. The aim of this study is to perform a randomized controlled clinical trial comparing two bone allografts: lyophilized and freeze bone allografts from human bone tissue bank. The investigators want to verify which one can develop greater osteogenesis, if is there any difference between them regarding the architectural trabeculae formation, if there are different patterns of reabsorption and finally if is there any differences between them regarding primary and lately dental implants stability. To answer those questions the investigators propose firstly, to carry out microtomographic and histological analysis from trephine bone samples after six months of sinus lifting and grafting in healthy participants undergoing osseointegrated dental implants. Secondly, the primary and lately implant stability is going to be achieved employing Resonance Frequency Analysis (RFA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Maxillary Sinus, Accessory; Bone, Bone Atrophy
Keywords
bone, maxillary sinus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group lyophilized bone allograft
Arm Type
Active Comparator
Arm Description
sinus lifting with tissue bank lyophilized bone filling
Arm Title
group freeze bone allograft
Arm Type
Active Comparator
Arm Description
sinus lifting with freeze bone bank filling
Intervention Type
Procedure
Intervention Name(s)
freeze bone allograft
Intervention Description
sinus lifting filling procedure employing freeze bone allograft from tissue bone bank.
Intervention Type
Procedure
Intervention Name(s)
lyophilized bone allograft
Intervention Description
sinus lifting filling procedure employing lyophilized bone allograft from tissue bone bank.
Primary Outcome Measure Information:
Title
volume of bone neoformation in mm3
Description
computational software for analysis the micro CT scanning of trephine bone samples images
Time Frame
six months after grafting
Title
area of bone neoformation in μm2
Description
IMAGEJ histomorphometric software for analysis of trephine bone samples micrographic images
Time Frame
six months after grafting
Secondary Outcome Measure Information:
Title
dental implants stability value
Description
primary implant stability by Resonance Frequency Analysis (RFA) in ISQ
Time Frame
six months after grafting
Title
dental implants stability value
Description
late stability by Resonance Frequency analysis (RFA) in ISQ
Time Frame
six months after dental implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy
totally or partially edentulous patients, bilaterally, in upper premolar or molar region; presenting maxillary sinus lifting necessity with bilateral alveolar bone height lower than 5mm and indication for at least one osseointegrated dental implant in premolar or molar region.
Exclusion Criteria:
recent sinusitis history
hypersensibility for sinus allergens, tabagism, ethylism
severe periodontal disease, diabetes, hypertension.
Cases that occur schneiderian membrane perforation will be excluded from the final sample.
12. IPD Sharing Statement
Citations:
PubMed Identifier
20452232
Citation
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Results Reference
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PubMed Identifier
23422679
Citation
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Results Reference
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PubMed Identifier
24909241
Citation
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Results Reference
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PubMed Identifier
23837530
Citation
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PubMed Identifier
23895252
Citation
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PubMed Identifier
9186204
Citation
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PubMed Identifier
18762629
Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
23184222
Citation
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Citation
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Citation
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Results Reference
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Comparative Study Between Lyophilized or Frozen Bone Allografts for Sinus-lifting
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