Vertical Ridge Augmentation Using Computer-guided Sandwich Osteotomy Technique

NCT07028606 | Active Not Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: Arginine - Glycine - Aspartic
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Researcher will introduce the trial to patients and provide full explanation of its aim and benefits in Arabic language. Patients will then be able to have an informed discussion with the researcher. Researcher will obtain written consent from patients willing to participate in the trial

Conditions

Alveolar Bone Resorption

Outcome Measures

Primary Outcomes (1)

• Effect of RGD on volumetric bone changes

  Cone beam computed tomography with minimal field of view was taken immediately after surgery, immediately before loading (6 months) and 6 months after loading to evaluate volumetric changes.

  Preoperative Cone beam computed tomography (CBCT) with minimal field of view will be taken for (implant treatment plan), immediately after surgery, at time of loading and 6 months after loading.

Study Arms (2)

Sandwich technique with xenograft, collagen membrane and simultaneous implant placement

PLACEBO COMPARATOR

(Control group) will receive computer-guided sandwich osteotomy technique with xenograft, collagen membrane and simultaneous implant placement.

Procedure: Sandwich technique with xenograft, collagen membrane and simultaneous implant placement.

Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement

ACTIVE COMPARATOR

(Study group) will receive computer-guided sandwich osteotomy technique with (RGD), xenograft, collagen membrane and simultaneous implant placement.

Biological: Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement.

Interventions

Sandwich technique with xenograft, collagen membrane and simultaneous implant placement. PROCEDURE

All surgery will be in upper arch, for sandwich osteotomy technique, after local anesthesia, crestal incision with buccal intrasulcular incisions will be done extending at least one tooth mesial and distal to the implant associated site. Full thickness mucoperiosteal flaps will be reflected to allow access for implant, distraction osteogenesis, xenograft. Osteotomy for implant will be carried out with advanced kit of roott\_system Switzerland brand, sandwich osteotomy technique will be carried out with three full thickness cuts using the tungsten carbide disc were performed in the form of two vertical cuts away from the neighboring teeth by 3 mm and one horizontal bony cut on the labial surface of alveolar ridge. Bone splitting chisels were used in sequential width (2 mm, 3 mm) and lightweight mallet to complete splitting of the bony segment, the surgical sites will be irrigated with sterile saline. Surgical flaps will be sutured to the pre-surgical level.

Sandwich technique with xenograft, collagen membrane and simultaneous implant placement

Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement. BIOLOGICAL

All surgery will be in upper arch, for sandwich osteotomy technique, after local anesthesia, crestal incision with buccal intrasulcular incisions will be done extending at least one tooth mesial and distal to the implant associated site. Full thickness mucoperiosteal flaps will be reflected to allow access for implant, distraction osteogenesis, xenograft with and with RGD. Injectable RGD-bioconjugate Mussel Adhesive Proteins (RGD-MAPs) composite hydroxypropyl methylcellulose (HPMC) hydrogels . Previously we developed a novel type of injectable self-supported hydrogel (2 mg/ml of RGD-MAPs/HPMC) based porcine nano hydroxyapatite (MPH) for dental graft, which could good handling property, biodegradation or biocompatibility with the hydrogel disassembly and provided efficient cell adhesion activity and no inflammatory responses. Surgical flaps will be sutured to the pre-surgical level with 4-0 polyproline non resorbable suture utilizing a single interrupted suturing technique.

Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults (age 30-45) with vertical ridge deficiency.
• Patients with maxillary vertical ridge deficiency 4-8mm according to Cologne Classification of Alveolar Ridge Defects (CCARD).
• Patients with good oral hygiene.
• Free from systemic diseases that may influence the outcome of the therapy.

You may not qualify if:

• Systemic conditions which are generally considered to be a contraindication to implant surgery which included but not limited to: osteoporosis, uncontrolled diabetes.
• Pregnant or lactating females
• Current or former smokers.
• Patient treated by immunosuppressive chemotherapy or radio therapy,
• Allergy to any material or medication used in the study.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University, Cairo, Boys

Cairo, Nasr City, 4450113, Egypt

Location

MeSH Terms

Interventions

Transplantation, Heterologous; arginyl-glycyl-aspartic acid

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients will be randomly assigned to either test or control groups using computer generated randomization (www.randomizer.org)
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Iecturer at Oral Medicine, Periodontology, Oral Radiology and Oral Diagnosis, Faculty of Oral and Dental Medicine, Al-Azhar University, Principal Investigator.

Model Details: The patients will be randomly assigned into two groups; Group 1: (Control group) will receive computer-guided sandwich osteotomy technique with xenograft, collagen membrane and simultaneous implant placement. Group 2: (Study group) will receive computer-guided sandwich osteotomy technique with (RGD), xenograft, collagen membrane and simultaneous implant placement.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: June 19, 2025
• Study Start: May 9, 2024
• Primary Completion: May 10, 2025
• Study Completion: June 10, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)