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Horizontal Maxillary Ridge Augmentation With Sticky Bone Versus Collagen Membrane GBR

Ridge Augmentation Using Autologous Concentrated Growth Factors (CGF) Enriched Bone Graft Matrix (Sticky Bone) Versus Guided Bone Regeneration Using Native Collagen Membrane in Horizontally Deficient Maxilla

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03697616
Enrollment
24
Registered
2018-10-05
Start date
2018-10-20
Completion date
2019-10-20
Last updated
2018-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Horizontal Deficiecy in Maxillary Arches

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.

Interventions

DEVICERidge 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Horizontal bone gain6 monthsThe amount of horizontal bone gain will be measured by cone beam computed tomography

Contacts

Primary ContactSarah Abdallah Mohamed, BDS
s.a_dent@hotmail.com+201117707035
Backup ContactMohamed Atef, PhD
zokasur@gmail.com+201009612708

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026