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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03712631
Other study ID # augmentation tunneling tech
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2018
Est. completion date December 2019

Study information

Verified date October 2018
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

aim Evaluation of the amount of bone gain following Ridge augmentation using tunneling technique in atrophic posterior mandibular ridges using anorganic bovine bone derived mineral mixed with particulated autogenous bone chips with collagen membrane


Description:

Bone grafting before implant placement has become a routine procedure over the last 20 years. A 5-year survival rate of up to98.3% for implants placed in grafted bone has been reported.

Autologous bone grafts are considered the gold standard.However, the success rate of the grafting procedure may beinfluenced by various risk factors.

A particular challenge isposed by an extensive graft of the alveolar ridge, with relativelyhigh complication rates of up to 20% being reported, mostcommonly dehiscence. More serious complications such asdehiscence or mobilization of the graft were observed in one third of smokers compared to a complication rate of only 7.7%for non-smokers. Complications such as flap necroses, dehiscenceand resorption are frequently soft-tissue complications.

A tension-free wound closure is a key factor in the successof bone grafts. Periosteal incisions are a common techniquefor flap extension. However, too many relief incisions in the periosteum may also result in an excessively thin or stretched wound flap.

This type of soft-tissue management may result in perforation or flap necrosis above the bone graft.

In 1987 Härle reported on a tunneling access in connectionwith a technique for preprosthetic jaw ridge grafting in the mandibular side-tooth region with bone replacement materials.

In the clinical experience of the authors the use of a tunneling technique for preparation without a crestal incision can present an alternative with autologous bone grafts to conventional surgical procedures with a trapezoid flap design.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 2019
Est. primary completion date May 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 50 Years
Eligibility Inclusion Criteria:

- medically free,age 22:50 years, atrophic posterior mandibleClinical diagnosis of Alzheimer's Disease Must be able to swallow tablets

Exclusion Criteria:

smoking Insulin dependent diabetes Clinical diagnosis of Alzheimer's Disease Must be able to swallow tablets

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
tunneling technique bone augmentation
horizontal ridge augmentation using mixture of xenograft,autogenous bone

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

References & Publications (39)

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AlGhamdi AS, Buhite RJ. A new tunnel technique with acellular dermal matrix for soft tissue preparation prior to symphyseal block graft--a description of technique and case report. J Oral Implantol. 2008;34(5):274-81. doi: 10.1563/1548-1336(2008)34[275:ANTTWA]2.0.CO;2. — View Citation

Block MS, Degen M. Horizontal ridge augmentation using human mineralized particulate bone: preliminary results. J Oral Maxillofac Surg. 2004 Sep;62(9 Suppl 2):67-72. — View Citation

Block MS, Kelley B. Horizontal posterior ridge augmentation: the use of a collagen membrane over a bovine particulate graft: technique note. J Oral Maxillofac Surg. 2013 Sep;71(9):1513-9. doi: 10.1016/j.joms.2013.05.015. — View Citation

Block MS. Horizontal ridge augmentation using particulate bone. Atlas Oral Maxillofac Surg Clin North Am. 2006 Mar;14(1):27-38. — View Citation

Buser D, Dula K, Belser U, Hirt HP, Berthold H. Localized ridge augmentation using guided bone regeneration. 1. Surgical procedure in the maxilla. Int J Periodontics Restorative Dent. 1993;13(1):29-45. — View Citation

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Cortellini P, Tonetti MS. A minimally invasive surgical technique with an enamel matrix derivative in the regenerative treatment of intra-bony defects: a novel approach to limit morbidity. J Clin Periodontol. 2007 Jan;34(1):87-93. — View Citation

Dahlin C, Gottlow J, Linde A, Nyman S. Healing of maxillary and mandibular bone defects using a membrane technique. An experimental study in monkeys. Scand J Plast Reconstr Surg Hand Surg. 1990;24(1):13-9. — View Citation

de Macedo LG, de Macedo NL, do Socorro Ferreira Monteiro A. Fresh-frozen human bone graft for repair of defect after adenomatoid odontogenic tumour removal. Cell Tissue Bank. 2009 Aug;10(3):221-6. doi: 10.1007/s10561-008-9120-1. Epub 2009 Jan 9. — View Citation

Deeb GR, Wilson GH, Carrico CK, Zafar U, Laskin DM, Deeb JG. Is the Tunnel Technique More Effective Than Open Augmentation With a Titanium-Reinforced Polytetrafluoroethylene Membrane for Horizontal Ridge Augmentation? J Oral Maxillofac Surg. 2016 Sep;74(9):1752-6. doi: 10.1016/j.joms.2016.04.031. Epub 2016 May 7. — View Citation

Flautre B, Maynou C, Lemaitre J, Van Landuyt P, Hardouin P. Bone colonization of beta-TCP granules incorporated in brushite cements. J Biomed Mater Res. 2002;63(4):413-7. — View Citation

Harris RJ. Soft tissue ridge augmentation with an acellular dermal matrix. Int J Periodontics Restorative Dent. 2003 Feb;23(1):87-92. — View Citation

Hasson O. Augmentation of deficient lateral alveolar ridge using the subperiosteal tunneling dissection approach. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Mar;103(3):e14-9. Epub 2007 Jan 22. — View Citation

Heller AL, Heller RL, Cook G, D'Orazio R, Rutkowski J. Soft tissue management techniques for implant dentistry: a clinical guide. J Oral Implantol. 2000;26(2):91-103. — View Citation

Heller AL, Heller RL. Tissue management protocol: "tunnel bone graft" technique. Dent Today. 2010 Nov;29(11):120, 122, 124. — View Citation

Kent JN. Reconstruction of the alveolar ridge with hydroxyapatite. Dent Clin North Am. 1986 Apr;30(2):231-57. — View Citation

Kfir E, Kfir V, Eliav E, Kaluski E. Minimally invasive guided bone regeneration. J Oral Implantol. 2007;33(4):205-10. — View Citation

Khan SN, Cammisa FP Jr, Sandhu HS, Diwan AD, Girardi FP, Lane JM. The biology of bone grafting. J Am Acad Orthop Surg. 2005 Jan-Feb;13(1):77-86. Review. — View Citation

Kuemmerle JM, Oberle A, Oechslin C, Bohner M, Frei C, Boecken I, von Rechenberg B. Assessment of the suitability of a new brushite calcium phosphate cement for cranioplasty - an experimental study in sheep. J Craniomaxillofac Surg. 2005 Feb;33(1):37-44. Epub 2005 Jan 11. — View Citation

Lee CT, Hamalian T, Schulze-Späte U. Minimally invasive treatment of soft tissue deficiency around an implant-supported restoration in the esthetic zone: modified VISTA technique case report. J Oral Implantol. 2015 Feb;41(1):71-6. doi: 10.1563/AAID-JOI-D-13-00043. Epub 2013 Mar 19. — View Citation

Li J, Xuan F, Choi BH, Jeong SM. Minimally invasive ridge augmentation using xenogenous bone blocks in an atrophied posterior mandible: a clinical and histological study. Implant Dent. 2013 Apr;22(2):112-6. doi: 10.1097/ID.0b013e3182805bec. — View Citation

Machtei EE. The effect of membrane exposure on the outcome of regenerative procedures in humans: a meta-analysis. J Periodontol. 2001 Apr;72(4):512-6. — View Citation

Maestre-Ferrín L, Boronat-López A, Peñarrocha-Diago M, Peñarrocha-Diago M. Augmentation procedures for deficient edentulous ridges, using onlay autologous grafts: an update. Med Oral Patol Oral Cir Bucal. 2009 Aug 1;14(8):e402-7. Review. — View Citation

Marshall SG. The combined use of endosseous dental implants and collagen/hydroxylapatite augmentation procedures for reconstruction/augmentation of the edentulous and atrophic mandible: a preliminary report. Oral Surg Oral Med Oral Pathol. 1989 Oct;68(4 Pt 2):517-25; discussion 525-6. — View Citation

McAllister BS, Haghighat K. Bone augmentation techniques. J Periodontol. 2007 Mar;78(3):377-96. Review. — View Citation

Mehlisch DR, Taylor TD, Leibold DG, Hiatt R, Waite DE, Waite PD, Laskin DM, Smith ST. Collagen/hydroxylapatite implant for augmenting deficient alveolar ridges: twelve-month clinical data. J Oral Maxillofac Surg. 1988 Oct;46(10):839-43. — View Citation

Misch CE, Dietsh F. Bone-grafting materials in implant dentistry. Implant Dent. 1993 Fall;2(3):158-67. Review. — View Citation

Misch CM. Comparison of intraoral donor sites for onlay grafting prior to implant placement. Int J Oral Maxillofac Implants. 1997 Nov-Dec;12(6):767-76. — View Citation

Penel G, Leroy N, Van Landuyt P, Flautre B, Hardouin P, Lemaître J, Leroy G. Raman microspectrometry studies of brushite cement: in vivo evolution in a sheep model. Bone. 1999 Aug;25(2 Suppl):81S-84S. — View Citation

Rothamel D, Schwarz F, Herten M, Ferrari D, Mischkowski RA, Sager M, Becker J. Vertical ridge augmentation using xenogenous bone blocks: a histomorphometric study in dogs. Int J Oral Maxillofac Implants. 2009 Mar-Apr;24(2):243-50. — View Citation

Rothstein SS, Paris DA, Zacek MP. Use of hydroxylapatite for the augmentation of deficient alveolar ridges. J Oral Maxillofac Surg. 1984 Apr;42(4):224-30. — View Citation

Sammartino G, Pantaleo G, Nuzzolo P, Amato M, Riccitiello F. Minimally Invasive Approaches to Optimize Block Grafting: A Case Report. J Oral Implantol. 2016 Apr;42(2):176-9. doi: 10.1563/aaid-joi-D-14-00076. Epub 2014 Sep 18. — View Citation

Simion M, Baldoni M, Rossi P, Zaffe D. A comparative study of the effectiveness of e-PTFE membranes with and without early exposure during the healing period. Int J Periodontics Restorative Dent. 1994 Apr;14(2):166-80. — View Citation

Smiler D, Soltan M, Lee JW. A histomorphogenic analysis of bone grafts augmented with adult stem cells. Implant Dent. 2007 Mar;16(1):42-53. — View Citation

Vanassche BJ, Stoelinga PJ, de Koomen HA, Blijdorp PA, Schoenaers JH. Reconstruction of the severely resorbed mandible with interposed bone grafts and hydroxylapatite. A 2-3 year follow-up. Int J Oral Maxillofac Surg. 1988 Jun;17(3):157-60. — View Citation

von Arx T, Hardt N, Wallkamm B. The TIME technique: a new method for localized alveolar ridge augmentation prior to placement of dental implants. Int J Oral Maxillofac Implants. 1996 May-Jun;11(3):387-94. — View Citation

Williams CW, Meyers JF, Robinson RR. Hydroxyapatite augmentation of the anterior portion of the maxilla with a modified transpositional flap technique. Oral Surg Oral Med Oral Pathol. 1991 Oct;72(4):395-9. — View Citation

Yan JJ, Tsai AY, Wong MY, Hou LT. Comparison of acellular dermal graft and palatal autograft in the reconstruction of keratinized gingiva around dental implants: a case report. Int J Periodontics Restorative Dent. 2006 Jun;26(3):287-92. — View Citation

* Note: There are 39 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Height and width of bone gained 4 months
Secondary Bone area percentage 4 months
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