Vertical Ridge Augmentation Using Computer-guided Sandwich Osteotomy Technique

NCT ID: NCT07028606

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-09
• Study Completion Date: 2025-06-10

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Sandwich technique with xenograft, collagen membrane and simultaneous implant placement

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

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: 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 (RGD), xenograft, collagen membrane and simultaneous implant placement

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Khairy morsi

Assistant Iecturer at Oral Medicine, Periodontology, Oral Radiology and Oral Diagnosis, Faculty of Oral and Dental Medicine, Al-Azhar University, Principal Investigator.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Al-Azhar University, Cairo, Boys

Cairo, Nasr City, Egypt

Countries

Egypt

Other Identifiers

Arginine - Glycine - Aspartic

Identifier Type: -

Identifier Source: org_study_id