CClinicalTrials.gg
Status unknownNCT03697616Updated Oct 5, 2018

Horizontal Maxillary Ridge Augmentation With Sticky Bone Versus Collagen Membrane GBR

An interventional study of Ridge augmentation with sticky bone and GBR in Horizontal Deficiecy in Maxillary Arches, sponsored by Cairo University. Status unknown. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-05.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Horizontal Deficiecy in Maxillary Arches
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts 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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • 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

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

06

What researchers measure

Primary outcomes

  1. Horizontal bone gain

    The amount of horizontal bone gain will be measured by cone beam computed tomography

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03697616
Lead sponsor
Cairo University
Responsible party
Sarah AbdAllah Mohamed (Principal investigator, Cairo University) — Principal investigator
First posted
Oct 5, 2018
Start date
Oct 20, 2018 (estimated)
Primary completion
Sep 20, 2019 (estimated)
Completion
Oct 20, 2019 (estimated)
Last update
Oct 5, 2018

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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