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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02577289
Other study ID # open_sinus_augmentation
Secondary ID
Status Recruiting
Phase N/A
First received October 13, 2015
Last updated October 14, 2015
Start date July 2015
Est. completion date December 2017

Study information

Verified date October 2015
Source Cairo University
Contact Waleed M. Nour El Din, BDS
Phone +2-01001448723
Email waleed_nour@live.com
Is FDA regulated No
Health authority Cairo University ethics committee (REC)' EGYPT ':'
Study type Interventional

Clinical Trial Summary

Evaluation of bone quantity in open sinus lift technique with space maintaining using platelet rich fibrin (PRF) as sole augmentation material versus nano crystalline hydroxyapatite with simultaneous placing of implants.


Description:

Evaluation of bone quantity in open sinus lift technique with simultaneous implantation using platelet rich fibrin (PRF) versus Nano-crystalline Hydroxyapatite as sole grafting material in patients with atrophied posterior maxillary ridge which provides a new modality for treatment of patients with atrophied posterior maxillary ridge with least cost and a much easier way using platelet rich fibrin (PRF) as substitution to bone graft


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date December 2017
Est. primary completion date October 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria:

- All patients should be seeking for implant supported prosthesis in posterior maxilla bilaterally

- All patients should have atrophied posterior maxillary ridge with the maximum height of the alveolar bone is from 3 mm to 5 mm

Exclusion Criteria:

- Ongoing steroid therapy;

- Uncontrolled diabetes;

- Recent cardiovascular diseases;

- Inflammation of the maxillary sinus;

- Previous radiant therapy for neoplastic pathologies

- Patient who have had previous failed sinus augmentation, or exhibited pathological finding or had a history of maxillary sinus disease or operations or whose medical condition might increase surgical risk of the research protocol were excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Atrophied Posterior Maxillary Ridge
  • Atrophy

Intervention

Procedure:
Evaluation of bone quantity in open sinus lift technique with simultaneous implantation ( Nano crystalline hydroxyapatite)
• The sinus cavity will be augmented with bone graft ( Nano crystalline hydroxyapatite)
Evaluation of bone quantity in open sinus lift technique with simultaneous implantation (PRF)
platelet rich fibrin (PRF) as sole grafting material in created space (PRF)

Locations

Country Name City State
Egypt Faculty of oral and dental medicine Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (26)

20. Best SM, Porter AE, Thian ES, Huang J: Bioceramics: Past, present and for the future. J Eur Ceram Soc 28: 1319, 2008.

23. Kalita SJ, Bhardwaj a, Bhatt H a: Nanocrystalline calcium phosphate ceramics in biomedical engineering. Mater Sci Eng CBiomimetic Supramol Sist 27: 441, 2007.

24. Mazor Z, Mamidwar S: Effect of Nanocrystalline Calcium Sulfate Bone Graft in a Bilateral Sinus-Augmentation Procedure: A Case Report. Clin Adv Periodontics 5: 76, 2015.

Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70. Review. Erratum in: Int J Oral Maxillofac Implants. 2008 Jan-Feb;2 — View Citation

Bohner M, Baumgart F. Theoretical model to determine the effects of geometrical factors on the resorption of calcium phosphate bone substitutes. Biomaterials. 2004 Aug;25(17):3569-82. — View Citation

Boyne PJ, James RA. Grafting of the maxillary sinus floor with autogenous marrow and bone. J Oral Surg. 1980 Aug;38(8):613-6. — View Citation

Chanavaz M. Maxillary sinus: anatomy, physiology, surgery, and bone grafting related to implantology--eleven years of surgical experience (1979-1990). J Oral Implantol. 1990;16(3):199-209. — View Citation

Cho JS, Ko YN, Koo HY, Kang YC. Synthesis of nano-sized biphasic calcium phosphate ceramics with spherical shape by flame spray pyrolysis. J Mater Sci Mater Med. 2010 Apr;21(4):1143-9. doi: 10.1007/s10856-009-3980-1. Epub 2010 Jan 6. — View Citation

Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. — View Citation

Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. Epub 2006 Jan 19. — View Citation

Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. Epub 2006 Jan 10. — View Citation

Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part III: leucocyte activation: a new feature for platelet concentrates? Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e51-5. — View Citation

Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. — View Citation

Ferraz MP, Monteiro FJ, Manuel CM. Hydroxyapatite nanoparticles: A review of preparation methodologies. J Appl Biomater Biomech. 2004 May-Aug;2(2):74-80. — View Citation

Fugazzotto PA, Vlassis J. Long-term success of sinus augmentation using various surgical approaches and grafting materials. Int J Oral Maxillofac Implants. 1998 Jan-Feb;13(1):52-8. — View Citation

Hürzeler MB, Kirsch A, Ackermann KL, Quiñones CR. Reconstruction of the severely resorbed maxilla with dental implants in the augmented maxillary sinus: a 5-year clinical investigation. Int J Oral Maxillofac Implants. 1996 Jul-Aug;11(4):466-75. — View Citation

Jaffin RA, Berman CL. The excessive loss of Branemark fixtures in type IV bone: a 5-year analysis. J Periodontol. 1991 Jan;62(1):2-4. — View Citation

Jemt T, Lekholm U. Implant treatment in edentulous maxillae: a 5-year follow-up report on patients with different degrees of jaw resorption. Int J Oral Maxillofac Implants. 1995 May-Jun;10(3):303-11. — View Citation

Lundgren S, Andersson S, Gualini F, Sennerby L. Bone reformation with sinus membrane elevation: a new surgical technique for maxillary sinus floor augmentation. Clin Implant Dent Relat Res. 2004;6(3):165-73. — View Citation

Mazor Z, Horowitz RA, Del Corso M, Prasad HS, Rohrer MD, Dohan Ehrenfest DM. Sinus floor augmentation with simultaneous implant placement using Choukroun's platelet-rich fibrin as the sole grafting material: a radiologic and histologic study at 6 months. J Periodontol. 2009 Dec;80(12):2056-64. doi: 10.1902/jop.2009.090252. — View Citation

Misch CE. Implant design considerations for the posterior regions of the mouth. Implant Dent. 1999;8(4):376-86. Review. — View Citation

Raghoebar GM, Batenburg RH, Timmenga NM, Vissink A, Reintsema H. Morbidity and complications of bone grafting of the floor of the maxillary sinus for the placement of endosseous implants. Mund Kiefer Gesichtschir. 1999 May;3 Suppl 1:S65-9. — View Citation

Sakka S, Coulthard P. Bone quality: a reality for the process of osseointegration. Implant Dent. 2009 Dec;18(6):480-5. doi: 10.1097/ID.0b013e3181bb840d. Review. — View Citation

Smiler DG, Johnson PW, Lozada JL, Misch C, Rosenlicht JL, Tatum OH Jr, Wagner JR. Sinus lift grafts and endosseous implants. Treatment of the atrophic posterior maxilla. Dent Clin North Am. 1992 Jan;36(1):151-86; discussion 187-8. Review. — View Citation

Sohn DS, Lee JS, Ahn MR, Shin HI. New bone formation in the maxillary sinus without bone grafts. Implant Dent. 2008 Sep;17(3):321-31. doi: 10.1097/ID.0b013e318182f01b. — View Citation

von Doernberg MC, von Rechenberg B, Bohner M, Grünenfelder S, van Lenthe GH, Müller R, Gasser B, Mathys R, Baroud G, Auer J. In vivo behavior of calcium phosphate scaffolds with four different pore sizes. Biomaterials. 2006 Oct;27(30):5186-98. Epub 2006 Jun 21. — View Citation

* Note: There are 26 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary The amount of new bone formation the sinus cavity using CBCT the amount of new bone formation of PRF in comparison with Nano-crystalline hydroxyappetite in millimeters using cone beam computed tomography (CBCT) 6 months No