Evaluation of Guided Tissue Regeneration With Autogenous Bone Chips and CGF During Implant Placement (CGF)

April 8, 2026 updated by: Meis Youssef Moustafa, Cairo University

Clinical and Radiographic Evaluation of Guided Tissue Regeneration Using Autogenous Bone Chips and Concentrated Growth Factors Membranes With Simultaneous Implant Placement. (Case Series)

CGF membranes will be prepared using a swing-lock centrifuge. A full-thickness mucoperiosteal flap will be elevated in a narrow alveolar ridge. Implants will be inserted. Autologous bone chips will be harvested via bone scraping and used for augmentation, CGF membranes will be placed over the grafted area. Suturing of the mucoperiosteal flap. Radiographic evaluation of the bone density and tissue thickness will be performed by CBCT preoperatively, immediate postoperative and after the procedure by 4 months. Clinical evaluation of the tissue thickness using periodontal probe preoperatively, immediate postoperatively and after the procedure by 4 months

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

  • Preoperative cone-beam computed tomography (CBCT) images will be obtained for surgical planning and for later comparison during follow-up evaluations.
  • Clinical evaluation of the tissue thickness using periodontal probe
  • Signed consent from the patient agreeing to the procedure
  • All surgical procedures will be performed by the same oral surgeon, following a standardized protocol to ensure consistency. The surgeries will be conducted in a sterilized dental operatory prepared specifically for oral surgery.
  • Patient preparation will include preoperative instructions and aseptic measures.

Sterile drapes will be placed to minimize contamination.

  • The patient will be prepared for phlebotomy, and a blood sample will be drawn into a sterile 10 mL tube without anticoagulant. The sample will be immediately centrifuged using a CGF-specific centrifuge under the designated CGF settings. To ensure proper balance during centrifugation, each tube will be counterbalanced with another tube containing either blood or water. After centrifugation is complete, the tubes will be removed, and the CGF clot will be carefully extracted. Using a PRF preparation tray, the red blood cell (RBC) layer will be separated from the fibrin matrix. The remaining CGF membrane will be ready for use.
  • Prior to surgery, the patient will rinse with 0.12% chlorhexidine gluconate as an antiseptic mouthwash. A topical anesthetic gel will be applied to the injection site prior to the administration of local anesthesia. Once both subjective and objective signs of anesthesia are confirmed, a mucoperiosteal flap will be elevated in a narrow alveolar ridge.
  • Autologous bone chips will be harvested via bone scraping and used for augmentation.
  • Implants will be inserted.
  • CGF membranes will be placed over the grafted area.
  • Interrupted sutures will be performed. Radiographic evaluation of the bone density and tissue thickness will be performed by CBCT, immediate postoperative and after the procedure by 4 months. Clinical evaluation of the tissue thickness using periodontal probe immediate postoperatively and after the procedure by 4 months.

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 (Estimated)

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.
8

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 Locations

  • Egypt
    • Cairo Governorate
      • Giza, Cairo Governorate, Egypt, 12511
        • Cairo University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

inclusion criteria:

  • A medical history that contraindicates oral surgical treatment such as (uncontrolled/untreated diabetes mellitus, immuno-compromised status, radio or chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous bisphosphonates).
  • Presence of active or untreated periodontal disease.
  • Vertical root fractures involving the buccal aspect.
  • Tooth /teeth with horizontal fractures below bone level.
  • Tooth /teeth with external or internal resorption.
  • Patients with destructive oral habits such as smoking, chewing tobacco, bruxism,etcetera(Chrcanovic et al., 2014).

exclusion criteria: A medical history that contraindicates oral surgical treatment such as (uncontrolled/untreated diabetes mellitus, immuno-compromised status, radio or chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous bisphosphonates).

  • Presence of active or untreated periodontal disease.
  • Vertical root fractures involving the buccal aspect.
  • Tooth /teeth with horizontal fractures below bone level.
  • Tooth /teeth with external or internal resorption.
  • Patients with destructive oral habits such as smoking, chewing tobacco, bruxism, etcetera(Chrcanovic et al., 2014).

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.
Other: GTR with Autogenous Bone Chips and CGF Membrane
Other: concentrated growth factor (CGF) Membrane
This is a third-generation autologous blood concentrate prepared using a dedicated centrifuge system. The process creates a fibrin-rich organic matrix from the patient's own blood, which is then molded into a membrane and packed over the grafted bone to enhance bone density increase and improvement of the surrounding tissue.

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
tissue biotype
Time Frame: preoperative, immediate postoperative and 4 months after the procedure
using periodontal probe to measure gingival thickness
preoperative, immediate postoperative and 4 months after the procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
bone density
Time Frame: preoperative, immediately postoperative, and 4 months after the surgery
cbct xray
preoperative, immediately postoperative, and 4 months after the surgery
patient satisfaction
Time Frame: after 4 months from the surgery
psq18 is a chart where the patient describes the level of their satisfaction
after 4 months from the surgery

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hesham Elsayed Elhawary, Professor, Cairo University
  • Study Director: Abdelmoez Mohamed El-Sharkawy, Assistant Professor, 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 (Estimated)

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.
April 16, 2026

Primary Completion (Estimated)

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 1, 2026

Study Completion (Estimated)

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 1, 2026

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).
April 3, 2026

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.
April 8, 2026

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.
April 13, 2026

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.
April 13, 2026

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.
April 8, 2026

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.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • omfs3-3-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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