Reconstruction of Deficient Atrophic Ridges Using Guide Bone Regeneration Technique

NCT06746935 | Recruiting

• 1 other identifier: 0000-0001-6142-0568
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

patients will be informed of the nature of the research work and informed consent will be obtained then randomized in 2 groups. Mixture 1:1 autogenous and xenogenic bone covered with Polytetrafluoroethylene membrane control group and study group p covered with native collagen membrane.

• Patients of both groups will be subjected to CBCT (diagnostic for upper arch), diagnostic wax-up and stent fabrication.
• Intra operative procedures (for both groups) followed by CBCT will be taken for every patient after 4 months. Both the study and control group will receive:
• In Recipient site, using 15C blade on Bard Parker handle incision of full thickness mucoperiosteal flap inorder to obtain, three-line pyramidal flap, reflection using mucoperiosteal elevator molt 9.
• The defective site is reevaluated after its primary evaluation on CBCT using UNC (University of North Carolina) periodontal probe and a template is cut using sterile suture pack, prior to donor site preparation.
• Flap advancement using periosteal releasing incision inorder to allow later tension free flap closure.
• In Donor site, mucoperiosteal flap is done, auto chip maker (ACM) is used for autogenous bone harvesting.
• Autogenous particulate bone graft is obtained using auto chip maker bur (ACM), in implant contra 20:1 using surgical motor recommended drilling speed 100 rpm and maximum torque 50 Ncm. as well as, using bone scrapper in push direction.
• Xenogenic bone graft particles (De-proteinized bovine bone mineral small granules (0.25-1 mm). is added to the autogenous bone particles to obtain homogenous mixture ratio 1:1.
• The gold standard is a mixture of autogenous bone containing viable cells and xenogenic bone which has slower rate of resorption is to be placed in recipient decorticated site and covered by PTFE membrane.
• The assemble is to be fixed by titanium bone tacks of diameter 2.5 mm and length 3.5 mm, to avoid micro movements of particulate bone assembly.
• In the Study group: The assemble is going to be covered by resorbable collagen membrane and fixed by tacks.
• Recheck adequate flap advancement by visualizing passive flap approximation, to allow tension free closure.
• Double line closure using horizontal mattress placed 5mm away from flap margins followed by interrupted sutures on top to allow contact area which is preferred to point contact and wound edge eversion.

Conditions

Ridge Augmentation; Bone Augmentation

Keywords

ridge augmentation; Polytetrafluoroethylene; native collagen membrane

Outcome Measures

Primary Outcomes (1)

• Quantity of bone gain.

  Measured using linear measurements from Cone Beam Computed Tomography (CBCT) in millimeters (mm).

  After 4 months from ridge augmentation.

Secondary Outcomes (1)

• Soft tissue dehiscence.

  Starting from Week 1. Binary Yes or No.

Other Outcomes (1)

• Pain assessment.

  Day 1.

Study Arms (2)

Control Group B polytetrafluoroethylene membrane.

ACTIVE COMPARATOR

Particulate bone mixture 1:1 autogenous and xenogenic bone covered with polytetrafluoroethylene membrane.

Procedure: Polytetrafluoroethylene membrane.

Study Group A native collagen membrane.

EXPERIMENTAL

Particulate bone mixture 1:1 autogenous and xenogenic bone covered with native collagen membrane.

Procedure: Collagen membrane.

Interventions

Collagen membrane. PROCEDURE

Particulate bone mixture 1:1 autogenous and xenogenic bone covered with native collagen membrane.

Study Group A native collagen membrane.

Polytetrafluoroethylene membrane. PROCEDURE

Particulate bone mixture 1:1 autogenous and xenogenic bone covered with polytetrafluoroethylene membrane.

Control Group B polytetrafluoroethylene membrane.

Eligibility Criteria

• Age: 20 Years - 48 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with maxillary residual alveolar bone height not less than 8 mm.
• Alveolar bone width from less than or equal 5 mm.
• Both sexes.
• At least missing single tooth.
• Previous Failed Implants.
• Previous Failed Grafting.

You may not qualify if:

• Heavy smokers more than 20 cigarettes per day.
• Patients with bone disease that may affect normal healing, example; hyperparathyroidism.
• Patients had radiotherapy and chemotherapy in head and neck.
• Patients had neoplasms in sites to be grafted.
• Patients with Metabolic diseases uncontrolled diabetic patients, Glycated hemoglobin (Hb A1c) more than 7 mg\\dl.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, 11553, Egypt

RECRUITING

Related Publications (20)

• Hammerle CH, Jung RE. Bone augmentation by means of barrier membranes. Periodontol 2000. 2003;33:36-53. doi: 10.1046/j.0906-6713.2003.03304.x. No abstract available.

  PMID: 12950840 BACKGROUND

• Pellegrino G, Lizio G, Corinaldesi G, Marchetti C. Titanium Mesh Technique in Rehabilitation of Totally Edentulous Atrophic Maxillae: A Retrospective Case Series. J Periodontol. 2016 May;87(5):519-28. doi: 10.1902/jop.2016.150432. Epub 2016 Jan 12.

  PMID: 26759078 BACKGROUND

• Polis-Yanes C, Cadenas-Sebastian C, Gual-Vaques P, Ayuso-Montero R, Mari-Roig A, Lopez-Lopez J. Guided Bone Regeneration of an Atrophic Maxilla Using Heterologous Cortical Lamina. Case Rep Dent. 2019 Jun 11;2019:5216362. doi: 10.1155/2019/5216362. eCollection 2019.

  PMID: 31308978 BACKGROUND

• Jensen J, Sindet-Pedersen S. Autogenous mandibular bone grafts and osseointegrated implants for reconstruction of the severely atrophied maxilla: a preliminary report. J Oral Maxillofac Surg. 1991 Dec;49(12):1277-87. doi: 10.1016/0278-2391(91)90303-4.

  PMID: 1955919 BACKGROUND

• 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.

  PMID: 9425757 BACKGROUND

• Montazem A, Valauri DV, St-Hilaire H, Buchbinder D. The mandibular symphysis as a donor site in maxillofacial bone grafting: a quantitative anatomic study. J Oral Maxillofac Surg. 2000 Dec;58(12):1368-71. doi: 10.1053/joms.2000.18268.

  PMID: 11117684 BACKGROUND

• Gungormus M, Yavuz MS. The ascending ramus of the mandible as a donor site in maxillofacial bone grafting. J Oral Maxillofac Surg. 2002 Nov;60(11):1316-8. doi: 10.1053/joms.2002.35731.

  PMID: 12420267 BACKGROUND

• Clavero J, Lundgren S. Ramus or chin grafts for maxillary sinus inlay and local onlay augmentation: comparison of donor site morbidity and complications. Clin Implant Dent Relat Res. 2003;5(3):154-60. doi: 10.1111/j.1708-8208.2003.tb00197.x.

  PMID: 14575631 BACKGROUND

• Pourabbas R, Nezafati S. Clinical results of localized alveolar ridge augmentation with bone grafts harvested from symphysis in comparison with ramus. J Dent Res Dent Clin Dent Prospects. 2007 Spring;1(1):7-12. doi: 10.5681/joddd.2007.002. Epub 2007 Jun 10.

  PMID: 23277827 BACKGROUND

• Acocella A, Bertolai R, Colafranceschi M, Sacco R. Clinical, histological and histomorphometric evaluation of the healing of mandibular ramus bone block grafts for alveolar ridge augmentation before implant placement. J Craniomaxillofac Surg. 2010 Apr;38(3):222-30. doi: 10.1016/j.jcms.2009.07.004. Epub 2009 Aug 3.

  PMID: 19648020 BACKGROUND

• Spin-Neto R, Landazuri Del Barrio RA, Pereira LA, Marcantonio RA, Marcantonio E, Marcantonio E Jr. Clinical similarities and histological diversity comparing fresh frozen onlay bone blocks allografts and autografts in human maxillary reconstruction. Clin Implant Dent Relat Res. 2013 Aug;15(4):490-7. doi: 10.1111/j.1708-8208.2011.00382.x. Epub 2011 Aug 11.

  PMID: 21834864 BACKGROUND

• Acocella A, Bertolai R, Ellis E 3rd, Nissan J, Sacco R. Maxillary alveolar ridge reconstruction with monocortical fresh-frozen bone blocks: a clinical, histological and histomorphometric study. J Craniomaxillofac Surg. 2012 Sep;40(6):525-33. doi: 10.1016/j.jcms.2011.09.004. Epub 2011 Nov 9.

  PMID: 22075326 BACKGROUND

• Dasmah A, Thor A, Ekestubbe A, Sennerby L, Rasmusson L. Particulate vs. block bone grafts: three-dimensional changes in graft volume after reconstruction of the atrophic maxilla, a 2-year radiographic follow-up. J Craniomaxillofac Surg. 2012 Dec;40(8):654-9. doi: 10.1016/j.jcms.2011.10.032. Epub 2011 Dec 3.

  PMID: 22137760 BACKGROUND

• AlGhamdi AS. Post-surgical complications of symphyseal block graft with and without soft tissue grafting. Saudi Med J. 2013 Jun;34(6):609-15.

  PMID: 23756926 BACKGROUND

• Hernandez-Alfaro F, Sancho-Puchades M, Guijarro-Martinez R. Total reconstruction of the atrophic maxilla with intraoral bone grafts and biomaterials: a prospective clinical study with cone beam computed tomography validation. Int J Oral Maxillofac Implants. 2013 Jan-Feb;28(1):241-51. doi: 10.11607/jomi.2405.

  PMID: 23377071 BACKGROUND

• Monje A, Monje F, Chan HL, Suarez F, Villanueva-Alcojol L, Garcia-Nogales A, Wang HL. Comparison of microstructures between block grafts from the mandibular ramus and calvarium for horizontal bone augmentation of the maxilla: a case series study. Int J Periodontics Restorative Dent. 2013 Nov-Dec;33(6):e153-61. doi: 10.11607/prd.1664.

  PMID: 24116370 BACKGROUND

• Aloy-Prosper A, Penarrocha-Oltra D, Penarrocha-Diago M, Penarrocha-Diago M. The outcome of intraoral onlay block bone grafts on alveolar ridge augmentations: a systematic review. Med Oral Patol Oral Cir Bucal. 2015 Mar 1;20(2):e251-8. doi: 10.4317/medoral.20194.

  PMID: 25662543 BACKGROUND

• Reininger D, Cobo-Vazquez C, Monteserin-Matesanz M, Lopez-Quiles J. Complications in the use of the mandibular body, ramus and symphysis as donor sites in bone graft surgery. A systematic review. Med Oral Patol Oral Cir Bucal. 2016 Mar 1;21(2):e241-9. doi: 10.4317/medoral.20938.

  PMID: 26827063 BACKGROUND

• Khoury F: Augmentation of severe bony defects with intraoral bone grafts: biological approach and long-term results J Oral Maxillo Fac Surg 2017Volume 46, Supplement 1, Pages 26-27.

  BACKGROUND

• Claudino M, Julio C L, Luis E M, Bernardo M, Fernando G, tomographic evaluation of atrophic maxilla rehabilitated with autogenous and xenogeneic block grafts. Journal of Research in Dentistry 2017, 4(4):112-117.

  BACKGROUND

Study Officials

• Ahmed M. Youssef, PHD.

  Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, Egypt

  STUDY DIRECTOR

Central Study Contacts

Mohannad A. Ismail, MSc.

CONTACT

+201222968444; mohannadahmed@hotmail.com

Zeyad adel Mostafa., MSc.

CONTACT

+201062227776; zeyad.adel@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The patients were randomly allocated into two groups utilizing Random Allocation Software version 2.0. then the allocation was concealed in opaque sealed envelopes. In both groups. The allocation was revealed to the operator just before the surgery. On the other hand, the patients, outcome assessor and the statistician who analyzed the collected data and performed the statistical analysis were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 24, 2024
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: October 29, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)