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Vertical Ridge Augmentation Using Computer-guided Sandwich Osteotomy Technique

NCT07028606 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-06-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-09
Primary Completion
2025-05-10
Completion
2025-06-10
FDA Drug
Yes
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07028606 on ClinicalTrials.gov