NCT07521514

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Apr 2026Oct 2026

First Submitted

Initial submission to the registry

April 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

April 16, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

April 3, 2026

Last Update Submit

April 8, 2026

Conditions

Keywords

CGFautogenous bone graftgingival biotypedental implantguided tissue regeneration

Outcome Measures

Primary Outcomes (1)

  • tissue biotype

    using periodontal probe to measure gingival thickness

    preoperative, immediate postoperative and 4 months after the procedure

Secondary Outcomes (2)

  • bone density

    preoperative, immediately postoperative, and 4 months after the surgery

  • patient satisfaction

    after 4 months from the surgery

Study Arms (1)

GTR with Autogenous Bone Chips and CGF Membrane

OTHER
Other: concentrated growth factor (CGF) Membrane

Interventions

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.

GTR with Autogenous Bone Chips and CGF Membrane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Cairo Governorate, 12511, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Hesham Elsayed Elhawary, Professor

    Cairo University

    STUDY CHAIR
  • Abdelmoez Mohamed El-Sharkawy, Assistant Professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

meis youssef moustafa, bachelors

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

April 3, 2026

First Posted

April 13, 2026

Study Start

April 16, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations