Assessment Of Guided Bone Regeneration Using Xenograft Mixed With Allogenic Bone Graft Versus Xenograft Mixed With Autogenous Graft For Augmentation Of Maxillary Alveolar Ridges

NCT07367464 | Recruiting DMC

• 1 other identifier: 23-5-24
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of Allogenic bone graft mixed with Xenograft in ratio 1:1, on the radiographic and histomorphometric assessment versus Autologous bone graft mixed with Xenograft in ratio 1:1 in maxillary deficient ridges، In guided bone regeneration of deficient edentulous maxillary ridges, will the application of Xenograft mixed with Allograft (1:1) be as effective as Xenograft mixed with Autogenous graft (1:1) in terms of dimensional ridge changes and Quality of newly formed bone? Evaluation of the patient's general condition of the oral cavity, to make sure it complies with the criteria required to be enrolled in the study in terms of oral hygiene and pathological conditions. A full thickness flap will be elevated with two releasing incisions, decortication of the buccal aspect of the ridge, placing of grafting material which will be covered by collagen pericardium membranes, tacks placement at the labial side to fix the membrane in place, horizontal mattress sutures as well as single interrupted and continuous with resorbable sutures for closure. Intervention group: will be filled with mixture of Xenogenic graft and the Allogenic bone graft chips. Control group: will be filled with mixture of Xenogenic graft and Autogenous bone particulate harvested either the ramus. For both groups, All the subjects will be taking CBCT at pre surgical and 6 months post surgical. outcomes : Bucco-Palatal horizontal bone gain, Alveolar ridge height, Percentage of new vital bone formation and Percentage of residual bone graft 6 months post-surgical.

Conditions

Guided Bone Regeneration

Keywords

Guided Bone Regeneration; DFDBA; Autogenous Bone Graft; Xenograft; Xenograft Mixed With Autogenous Bone Graft; Xenograft Mixed With Allogenic Bone Graft; Deficient Maxillary Alveolar Ridges

Outcome Measures

Primary Outcomes (1)

• Bucco-Palatal horizontal bone gain

  Bone width will be measured from the reformatted cross-sectional image of the CBCT 2 mm below the tip of the crest at every single deficient site taking a specific anatomical landmark in the opposing teeth as a reference point for the measurements taking into consideration that the patients are biting in maximum intercuspation. The average of these measurements will be calculated to be a representative value of the preoperative width for each case from the preoperative CBCT. Immediate and 6 months postoperative CBCT will be done while the patients are also biting in maximum intercuspation and the same measurements will be taken from the same reference areas previously selected from the preoperative scan.

  6 months postoperatively

Secondary Outcomes (3)

• Alveolar ridge height:

  6 months postoperatively

• Percentage of new vital bone formation

  6 months postoperatively

• Percentage of residual bone graft

  6 months postoperatively

Study Arms (2)

Allogenic bone graft mixed with Xenograft in ratio 1:1

EXPERIMENTAL

A full thickness flap will be elevated with two releasing incisions extending at least just distal to each tooth adjacent to the defect site.The flap will be reflected adequately to expose the defect. The cortical bone will be perforated with a small round bur to perform decortication of the buccal aspect of the ridge. recipient site will be debrided from any soft tissue or periosteum remnants.The grafts will be placed on the buccal aspect of the alveolar ridge, layer by layer, gently pressed to the recipient site then it will be covered by a collagen pericardium membranes. The membrane will be stretched tightly over the graft and titanium tacks will be placed at the labial side to fix the membrane in place. The incisions will be carefully closed with horizontal mattress sutures as well as single interrupted and continuous with resorbable sutures.

Biological: Allogenic bone graft mixed with Xenograft in ratio 1:1

Autologous bone graft mixed with Xenograft in ratio 1:1

ACTIVE COMPARATOR

A full thickness flap will be elevated with two releasing incisions extending at least just distal to each tooth adjacent to the defect site.The flap will be reflected adequately to expose the defect. The cortical bone will be perforated with a small round bur to perform decortication of the buccal aspect of the ridge. recipient site will be debrided from any soft tissue or periosteum remnants.The grafts will be placed on the buccal aspect of the alveolar ridge, layer by layer, gently pressed to the recipient site then it will be covered by a collagen pericardium membranes. The membrane will be stretched tightly over the graft and titanium tacks will be placed at the labial side to fix the membrane in place. The incisions will be carefully closed with horizontal mattress sutures as well as single interrupted and continuous with resorbable sutures.

Biological: Autologous bone graft mixed with Xenograft in ratio 1:1

Interventions

Autologous bone graft mixed with Xenograft in ratio 1:1 BIOLOGICAL

Autogenous bone particulate will be harvested from the mandibular ramus. Mandibular ramus as a donor site: A submarginal incision will be placed within the keratinized mucosa opposite to the lower first molar and extending 1 cm along the ramus of the mandible.

Autologous bone graft mixed with Xenograft in ratio 1:1

Allogenic bone graft mixed with Xenograft in ratio 1:1 BIOLOGICAL

Xenogenic graft is then to be mixed in equal 1:1 volume of particles size 0.25-1 mm with the Allogenic bone graft chips to create 1:1 composite graft.

Allogenic bone graft mixed with Xenograft in ratio 1:1

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 20-50 years.
• Totally or partially edentulous maxillary ridges.
• Patients with insufficient bone for an implant placement.
• Residual alveolar width ranging from 2 to 4 mm.
• Minimum of 10 mm vertical dimension to nasal floor or sinus floor.
• Patients with healthy systemic condition (Medically free).
• Adequate inter-arch space for placement of the implant prosthetic part.

You may not qualify if:

• Pathological lesions in the defect site.
• Systemic diseases that would interfere with bone metabolism. Uncontrolled diabetic patients.
• Ongoing treatment or a history of recent chemotherapy or radiotherapy.
• Patient with medical condition that contraindicates surgical procedures.
• Patients on medication that may interfere with healing (Corticosteroids, Bisphosphonate, Chemo/radio therapy).
• Patients with vertical bone deficiency.
• Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or para-functional habits.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Mohamed A. Abousetta, Bachelor

  Cairo University

  PRINCIPAL INVESTIGATOR

• Mohamed M. Shaker, Professor

  Cairo University

  STUDY CHAIR

• Weam A. El-Battawy, Ass. Prof.

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mohamed A. Abousetta

CONTACT

+201044276208; mohamed.abousetta@dentistry.cu.edu.eg

Mohamed M. Shaker

CONTACT

+20100 1505798; mohamed.mounir@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of the participants and the operator is not applicable, however outcome assessors and bio-statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree student, Implantology department, Faculty of Dentistry, Cairo University

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 26, 2026
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

EG (1)