Guided Bone Regeneration Using a Mixture of Autogenous and Xenograft Particulate Versus Patient-Specific Sticky Bone for Horizontal Anterior Maxillary Defect

NCT07113886 | Not Yet Recruiting

• 1 other identifier: GBR In Anterior Maxilla
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to enhance healing while minimizing invasiveness and restoring tissues to their proper structure and function by using patient specific sticky bone that will enhance the soft tissue reaction and maintain the graft volume stability and bone quality which stabilizes bone grafts, accelerates tissue healing, and reduces bone loss.

Conditions

Sticky Bone

Keywords

ridge augmentation, horizontal bone defects, sticky bone

Outcome Measures

Primary Outcomes (2)

• Radiographic and Histomorphometric Assessment for Guided Bone Regeneration using a Mixture of Autogenous and Xenograft Particulate Versus Patient-Specific Sticky Bone for Horizontal Anterior Maxillary Defect (Randomized Clinical Trial)

  Baseline (preoperative), 6 months postoperative for radiographic evaluation; 6 months postoperative for histomorphometric biopsy assessment at re-entry.

• Radiographic and Histomorphometric Assessment for Guided Bone Regeneration using a Mixture of Autogenous and Xenograft Particulate Versus Patient-Specific Sticky Bone for Horizontal Anterior Maxillary Defect (Randomized Clinical Trial)

  Radiographic outcomes will include CBCT-based measurements of horizontal ridge width and bone volume gain at the grafted sites. Histomorphometric evaluation will be performed using biopsies collected at re-entry to assess new bone formation, residual graft particles, and connective tissue. Comparisons will be made between autogenous/xenograft particulate grafts and patient-specific sticky bone in terms of bone regeneration effectiveness.

  Baseline (preoperative), 6 months postoperative for radiographic evaluation; 6 months postoperative for histomorphometric biopsy assessment at re-entry.

Study Arms (2)

Autogenous + Xenograft particulate group.

ACTIVE COMPARATOR

Procedure: Mixture of Autogenous and Xenograft Particulates

Patient-specific Sticky Bone group.

EXPERIMENTAL

Procedure: Patient-Specific Sticky Bone

Interventions

Mixture of Autogenous and Xenograft Particulates PROCEDURE

This group will receive guided bone regeneration using a 1:1 mixture of autogenous bone harvested from the mandibular ramus and xenograft bone substitute (e.g., Bio-Oss). The graft material will be covered with a titanium meshes. Standard flap design, fixation, and suturing techniques will be used

Autogenous + Xenograft particulate group.

Patient-Specific Sticky Bone PROCEDURE

This group will receive guided bone regeneration using patient-specific sticky bone, created by mixing autogenous bone and xenograft with autologous fibrin glue (PRF). The sticky bone graft will be molded and applied directly to the defect site, covered with a titanium meshes, and stabilized using standard surgical protocol.

Patient-specific Sticky Bone group.

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both genders requiring implants placement in anterior maxilla with horizontal bone defect.
• Patients of age older than 20 years old.
• Patients with adequate Inter-arch space.
• Patients who were willing and fully capable to comply with the study protocol.

You may not qualify if:

• Heavy smokers (\> than 10 cigarettes a day)
• Patients with parafunctional habits
• Patients with uncontrolled systemic diseases.
• Patients with poor oral hygiene
• Patients with mental instabilities or psychic patient

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Oral & Maxillofacial Surgery Faculty of Dentistry - Cairo University

Cairo, Egypt

Location

Study Officials

• Ass. Prof. Dr. Mohamed Mounir Mounir Associate professor of Oral and Maxillofacial Surgery, Associate professor

  Oral & Maxillofacial Surgery Faculty of Dentistry - Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Mohamed Mohsen Doctor

CONTACT

01068183496; mohamed.nasr@dentistry.cu.edu.eg

Dr. Mohsen Mohamed Nasr, BDS Oral & Dental Medicine

CONTACT

01020557881; mohamed.nasr@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR Mohamed Mohsen Mohamed Nasr

Model Details: Interventions 1. Preoperative preparation: History: Thorough history will be taken for all patients to identify their chief complain, medical history and dental condition. All data will be collected in the diagnostic sheet. (Appendix A) Clinical examination: • A thorough physical examination will be conducted, emphasizing the oral cavity and maxillofacial region. This includes assessing the condition of the teeth, gums, and surrounding tissues, as well as evaluating the anatomy of the maxiia . Consent: • Informed consent will be obtained from patients regarding the surgical procedure and inclusion criteria in the study Radiographic examination: • Preoperative imaging using CBCT will be performed to assess the anatomy of the maxillary bone , and the quality and quantity of bone available for grafting and to exlude the presence of any pathosis. 2. Intra operative Surgical Procedure: Phase 1: • All surgical procedures will be performed under local Anesthesia utilizing two

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

EG (1)