NCT07028606

Vertical Ridge Augmentation Using Computer-guided Sandwich Osteotomy Technique

Effect of Arginine - Glycine - Aspartic Acid (RGD) Hydrogel on Vertical Ridge Augmentation Using Computer-guided Sandwich Osteotomy Technique, With Xenograft and Simultaneous Implant Placement

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 30 Years – 45 Years
• Healthy volunteers: Not accepted

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

Detailed description

This protocol and the template informed consent form will be reviewed by the Ethics Committee of Scientific Research -Faculty of Oral and Dental Medicine- Al-Azhar University.

Conditions

• Alveolar Bone Resorption

Interventions

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

Timeline

• Start date: 2024-05-09
• Primary completion: 2025-05-10
• Completion: 2025-06-10
• First posted: 2025-06-19
• Last updated: 2025-06-19

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study
• FDA-regulated device study