Horizontal Maxillary Ridge Augmentation With Sticky Bone Versus Collagen Membrane GBR

Not Applicable

• Conditions: Horizontal Deficiecy in Maxillary Arches
• Interventions: Device: Ridge augmentation with sticky bone and GBR

• Registration Number: NCT03697616
• Lead Sponsor: Cairo University

Brief Summary

Guided bone regeneration (GBR) using bone graft and barrier membrane is a well-established technique for augmentation of atrophic alveolar ridges. There are many techniques for ridge augmentation involves the use of bone grafting materials, barrier membranes, possibly some tenting/fixation screws the stability of bone graft, space maintenance, angiogenesis, and tension free primary suture are essential for success.

Detailed Description

Common techniques introduced for horizontal ridge augmentation are Guided Bone Regeneration (GBR), there are many techniques for ridge augmentation involves the use of bone grafting materials, barrier membranes, possibly some tenting/fixation screws. For successful GBR, stability of bone graft, space maintenance, angiogenesis, and tension free primary suture are essential. Space maintenance with particulate bone graft should be provided during healing period. However particulate bone graft is easily migrated when grafted on the large horizontal bone defect. To reconstruct large bony defect or for the 3-dimensional ridge augmentation, bone tack on the collagen membrane or titanium mesh is required to contain particulate bone graft during healing but these procedures are surgically time consuming and technique sensitive.

Sticky bone is biologically solidified bone graft which is entrapped in fibrin network. Sticky bone graft doesn't scatter because particulate bone powders are strongly interconnected each other by fibrin network.

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-04
• Last Update Submitted: 2018-10-04
• Study First Posted: 2018-10-05
• Last Update Posted: 2018-10-05
• Study Start: 2018-10-20
• Primary Completion: 2019-09-20
• Study Completion: 2019-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Inadequate facial bone obviating prosthodontically planned implant placement in the maxilla
• Both sexes.
• No intraoral soft and hard tissue pathology
• No systemic condition that contraindicate implant placement.

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Exclusion Criteria

• Significant bone-related illness or pathology.
• Heavy smokers more than 20 cigarettes per day.
• Patients with systemic disease that may affect normal healing.
• Psychiatric problems
• Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
• Immunodeficiency pathology, bruxism, stress situation (socially or professionally).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ridge augmentation with sticky bone and GBR	Ridge augmentation with sticky bone and GBR	Ridge augmentation using Autologous concentrated Growth factors (CGF) enriched bone graft matrix (sticky bone) and guided bone regeneration using native collagen membrane in horizontally deficient maxilla

Primary Outcome Measures

Name	Time	Method
Horizontal bone gain	6 months	The amount of horizontal bone gain will be measured by cone beam computed tomography