Horizontal Maxillary Ridge Augmentation With Sticky Bone Versus Collagen Membrane GBR

NCT ID: NCT03697616

Last Updated: 2018-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-20
• Study Completion Date: 2019-10-20

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.

Conditions

Horizontal Deficiecy in Maxillary Arches

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Ridge augmentation with sticky bone and GBR

Intervention Type: DEVICE

• Autogenous particulate bone will be harvested and a mixture of autogenous particulate and anorganic bovine bone mineral will be prepared at a ratio of 1:1
• Venous blood will be drawn from patients' forearm and centrifuged at 2500 RPM/3 minutes and 4000 RPM/15 minutes to produce autologous fibrin glue and concentrated growth factors membrane, respectively
• Sticky bone will be prepared by adding autologous fibrin glue to the particulate mixture, placed onto the defect and covered by the prepared concentrated growth factors membrane
• For guided bone regeneration the particulate mixture will be placed onto the defect and covered by resorbable collagen membrane
• Periosteal releasing incision will be done to provide flap advancement for tension free closure
• Closure will be done using horizontal mattress and interrupted 4/0 polypropylene sutures

Interventions

Ridge augmentation with sticky bone and GBR

• Autogenous particulate bone will be harvested and a mixture of autogenous particulate and anorganic bovine bone mineral will be prepared at a ratio of 1:1
• Venous blood will be drawn from patients' forearm and centrifuged at 2500 RPM/3 minutes and 4000 RPM/15 minutes to produce autologous fibrin glue and concentrated growth factors membrane, respectively
• Sticky bone will be prepared by adding autologous fibrin glue to the particulate mixture, placed onto the defect and covered by the prepared concentrated growth factors membrane
• For guided bone regeneration the particulate mixture will be placed onto the defect and covered by resorbable collagen membrane
• Periosteal releasing incision will be done to provide flap advancement for tension free closure
• Closure will be done using horizontal mattress and interrupted 4/0 polypropylene sutures

Intervention Type: DEVICE

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sarah AbdAllah Mohamed

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sarah Abdallah Mohamed, BDS

Role: CONTACT

s.a_dent@hotmail.com

+201117707035

Mohamed Atef, PhD

Role: CONTACT

zokasur@gmail.com

+201009612708

Other Identifiers

CairoUImp

Identifier Type: -

Identifier Source: org_study_id