Horizontal Maxillary Ridge Augmentation With Sticky Bone Versus Collagen Membrane GBR

October 4, 2018 updated by: Sarah AbdAllah Mohamed, Cairo University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Horizontal bone gain
Time Frame: 6 months
The amount of horizontal bone gain will be measured by cone beam computed tomography
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CairoUImp

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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