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

Bone Atrophy Clinical Trial

Official title:

Histological and Microtomographic Comparative Study Between Lyophilized or Frozen Bone Allografts for Sinus-lifting: A Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02583737
• Other study ID #: CAEE 30738714.0.0000.0075.
• Status: Active, not recruiting
• Phase: N/A
• First received: October 19, 2015
• Last updated: May 10, 2016
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Accessory; Bone
• Bone Atrophy
• Disorder of Maxillary Sinus

Intervention

Procedure:
• freeze bone allograft
sinus lifting filling procedure employing freeze bone allograft from tissue bone bank.
• lyophilized bone allograft
sinus lifting filling procedure employing lyophilized bone allograft from tissue bone bank.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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]. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	volume of bone neoformation in mm3	computational software for analysis the micro CT scanning of trephine bone samples images	six months after grafting	No
Primary	area of bone neoformation in µm2	IMAGEJ histomorphometric software for analysis of trephine bone samples micrographic images	six months after grafting	No
Secondary	dental implants stability value	primary implant stability by Resonance Frequency Analysis (RFA) in ISQ	six months after grafting	No
Secondary	dental implants stability value	late stability by Resonance Frequency analysis (RFA) in ISQ	six months after dental implant	No