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NCT Number: NCT07028606

Vertical Ridge Augmentation Using Computer-guided Sandwich Osteotomy Technique

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

30 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Al-Azhar University, Cairo, Boys

Cairo, Nasr City, 4450113, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 (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.

Primary outcomes

  1. Effect of RGD on volumetric bone changes

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Acronym: RGD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 19, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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