Reconstruction of Deficient Atrophic Ridges Using Guide Bone Regeneration Technique

Official title

Reconstruction of Deficient Atrophic Ridges Using Guided Bone Regeneration Technique With Native Collagen Membrane and Polytetrafluoroethylene Membrane (Randomized Clinical Trial)

Overview

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.

Detailed description

.General operative procedures The selected patients will be informed of the nature of the research work and informed consent will be obtained then randomized in equal proportions between control group particulate bone mixture 1:1 autogenous and xenogenic bone covered with Polytetrafluoroethylene membrane and study group particulate bone mixture 1:1 autogenous and xenogenic bone 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. * Infiltration local anesthesia will be given to the patient (Articaine 4% 1:100 000 epinephrine).

Both the study and control group will receive:

* In Recipient site, preparation 1st to obtain, three-line pyramidal flap. * Flap advancement using periosteal releasing incision. * In Donor site, auto chip maker (ACM) is used for autogenous bone harvesting and xenogenic bone graft particles mixture ratio 1:1. * The assemble is to be fixed by titanium bone tacks. In the Study group: The assemble is going to be covered by collagen membrane. * 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.

Interventions

• Procedure Collagen membrane.
  Particulate bone mixture 1:1 autogenous and xenogenic bone covered with native collagen membrane.
• Procedure Polytetrafluoroethylene membrane.
  Particulate bone mixture 1:1 autogenous and xenogenic bone covered with polytetrafluoroethylene membrane.

Primary outcome measures

• Quantity of bone gain. [Time frame: After 4 months from ridge augmentation.]

Secondary outcome measures (1)

• Soft tissue dehiscence. [Time frame: Starting from Week 1. Binary Yes or No.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Dentistry Cairo University — Cairo

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06746935 · 0000-0001-6142-0568

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗