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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
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder of Maxillary Sinus focused on measuring bone, maxillary sinus

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 19, 2015
    Last Updated
    May 10, 2016
    Sponsor
    University of Sao Paulo
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    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
    Acocella A, Bertolai R, Nissan J, Sacco R. Clinical, histological and histomorphometrical study of maxillary sinus augmentation using cortico-cancellous fresh frozen bone chips. J Craniomaxillofac Surg. 2011 Apr;39(3):192-9. doi: 10.1016/j.jcms.2010.03.019. Epub 2010 May 7.
    Results Reference
    background
    PubMed Identifier
    23422679
    Citation
    Chiapasco M, Giammattei M, Carmagnola D, Autelitano L, Rabbiosi D, Dellavia C. Iliac crest fresh-frozen allografts and autografts in maxillary and mandibular reconstruction: a histologic and histomorphometric evaluation. Minerva Stomatol. 2013 Jan-Feb;62(1-2):3-16. English, Italian.
    Results Reference
    background
    PubMed Identifier
    24909241
    Citation
    de Castilho TR, Tortamano P, Marotti J, de Andrade JC Jr, Chilvarquer I, Ximenez ME, Alves MT. Clinical and Histomorphometric Evaluation of Fresh Frozen Bone Allograft in Sinus Lift Surgery. Clin Implant Dent Relat Res. 2016 Feb;18(1):40-50. doi: 10.1111/cid.12234. Epub 2014 Jun 6.
    Results Reference
    background
    PubMed Identifier
    23837530
    Citation
    Deluiz D, Oliveira LS, Pires FR, Tinoco EM. Time-dependent changes in fresh-frozen bone block grafts: tomographic, histologic, and histomorphometric findings. Clin Implant Dent Relat Res. 2015 Apr;17(2):296-306. doi: 10.1111/cid.12108. Epub 2013 Jul 9.
    Results Reference
    background
    PubMed Identifier
    23895252
    Citation
    Eskan MA, Greenwell H, Hill M, Morton D, Vidal R, Shumway B, Girouard ME. Platelet-rich plasma-assisted guided bone regeneration for ridge augmentation: a randomized, controlled clinical trial. J Periodontol. 2014 May;85(5):661-8. doi: 10.1902/jop.2013.130260. Epub 2013 Jul 29.
    Results Reference
    background
    PubMed Identifier
    9186204
    Citation
    Goulet JA, Senunas LE, DeSilva GL, Greenfield ML. Autogenous iliac crest bone graft. Complications and functional assessment. Clin Orthop Relat Res. 1997 Jun;(339):76-81. doi: 10.1097/00003086-199706000-00011.
    Results Reference
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    PubMed Identifier
    18762629
    Citation
    Holtzclaw D, Toscano N, Eisenlohr L, Callan D. The safety of bone allografts used in dentistry: a review. J Am Dent Assoc. 2008 Sep;139(9):1192-9. doi: 10.14219/jada.archive.2008.0334.
    Results Reference
    background
    PubMed Identifier
    20116718
    Citation
    Le B, Rohrer MD, Prasad HS. Screw "tent-pole" grafting technique for reconstruction of large vertical alveolar ridge defects using human mineralized allograft for implant site preparation. J Oral Maxillofac Surg. 2010 Feb;68(2):428-35. doi: 10.1016/j.joms.2009.04.059. Epub 2010 Jan 15. Erratum In: J Oral Maxillofac Surg. 2010 Apr;68(4):953. Prassad, Hari S [corrected to Prasad, Hari S].
    Results Reference
    background
    PubMed Identifier
    23184222
    Citation
    Pimentel AC, Napimoga MH, Manzi MR, Sendyk WR. Reconstruction of the edentulous mandible with fresh frozen bone grafts and implants: a 4-year report of a prospective clinical study. Cell Tissue Bank. 2014 Mar;15(1):1-6. doi: 10.1007/s10561-012-9352-y. Epub 2012 Nov 27.
    Results Reference
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    PubMed Identifier
    20473718
    Citation
    Pelegrine AA, Sorgi da Costa CE, Sendyk WR, Gromatzky A. The comparative analysis of homologous fresh frozen bone and autogenous bone graft, associated or not with autogenous bone marrow, in rabbit calvaria: a clinical and histomorphometric study. Cell Tissue Bank. 2011 Aug;12(3):171-84. doi: 10.1007/s10561-010-9178-4. Epub 2010 May 16.
    Results Reference
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    PubMed Identifier
    17348885
    Citation
    Schwartz Z, Goldstein M, Raviv E, Hirsch A, Ranly DM, Boyan BD. Clinical evaluation of demineralized bone allograft in a hyaluronic acid carrier for sinus lift augmentation in humans: a computed tomography and histomorphometric study. Clin Oral Implants Res. 2007 Apr;18(2):204-11. doi: 10.1111/j.1600-0501.2006.01303.x.
    Results Reference
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