Comparative Study Between Lyophilized or Frozen Bone Allografts for Sinus-lifting

NCT02583737 | Unknown

• 1 other identifier: CAEE 30738714.0.0000.0075.
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Disorder of Maxillary Sinus; Accessory; Bone; Bone Atrophy

Keywords

bone; maxillary sinus

Outcome Measures

Primary Outcomes (2)

• volume of bone neoformation in mm3

  computational software for analysis the micro CT scanning of trephine bone samples images

  six months after grafting

• area of bone neoformation in μm2

  IMAGEJ histomorphometric software for analysis of trephine bone samples micrographic images

  six months after grafting

Secondary Outcomes (2)

• dental implants stability value

  six months after grafting

• dental implants stability value

  six months after dental implant

Study Arms (2)

group lyophilized bone allograft

ACTIVE COMPARATOR

sinus lifting with tissue bank lyophilized bone filling

Procedure: lyophilized bone allograft

group freeze bone allograft

ACTIVE COMPARATOR

sinus lifting with freeze bone bank filling

Procedure: freeze bone allograft

Interventions

freeze bone allograft PROCEDURE

sinus lifting filling procedure employing freeze bone allograft from tissue bone bank.

group freeze bone allograft

lyophilized bone allograft PROCEDURE

sinus lifting filling procedure employing lyophilized bone allograft from tissue bone bank.

group lyophilized bone allograft

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Related Publications (11)

• 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.

  PMID: 20452232 BACKGROUND

• 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.

  PMID: 23422679 BACKGROUND

• 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.

  PMID: 24909241 BACKGROUND

• 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.

  PMID: 23837530 BACKGROUND

• 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.

  PMID: 23895252 BACKGROUND

• 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.

  PMID: 9186204 BACKGROUND

• 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.

  PMID: 18762629 BACKGROUND

• 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.

  PMID: 20116718 BACKGROUND

• 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.

  PMID: 23184222 BACKGROUND

• 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.

  PMID: 20473718 BACKGROUND

• 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.

  PMID: 17348885 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 22, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 11, 2016

Record last verified: 2016-05