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Horizontal Maxillary Ridge Augmentation With Sticky Bone Versus Collagen Membrane GBR

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ClinicalTrials.gov Identifier: NCT03697616
Recruitment Status : Not yet recruiting
First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Sarah AbdAllah Mohamed, 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.

Condition or disease Intervention/treatment Phase
Horizontal Deficiecy in Maxillary Arches Device: Ridge augmentation with sticky bone and GBR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : October 20, 2018
Estimated Primary Completion Date : September 20, 2019
Estimated Study Completion Date : October 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts
Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: 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
Device: 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




Primary Outcome Measures :
  1. Horizontal bone gain [ Time Frame: 6 months ]
    The amount of horizontal bone gain will be measured by cone beam computed tomography



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697616


Contacts
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Contact: Sarah Abdallah Mohamed, BDS +201117707035 s.a_dent@hotmail.com
Contact: Mohamed Atef, PhD +201009612708 zokasur@gmail.com

Sponsors and Collaborators
Cairo University
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Responsible Party: Sarah AbdAllah Mohamed, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03697616    
Other Study ID Numbers: CairoUImp
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No