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Clinical and Patient-reported Outcomes of Guided Versus Freehand Harvesting Of Positioning of Autogenous Bone Shells
Sponsor: Shalash Dental education
Summary
When people lose teeth or have gum disease, the jawbone can shrink over time. This shrinkage makes it difficult for dentists to place dental implants because implants need a strong and stable base of bone. To solve this problem, surgeons often use bone grafting techniques. One of the most reliable ways to rebuild lost bone is called the autogenous shell technique. In this method, very thin plates of bone are taken from another part of the patient's mouth, shaped into a "shell," and fixed into place at the site where bone is missing. The empty space inside the shell is then filled with tiny bone chips, and the whole graft heals into strong new bone over time. Once healed, implants can be placed securely. This technique has been widely studied and is considered highly effective. However, it is not easy to perform. Traditionally, the shells are harvested and positioned by hand, relying heavily on the skill and experience of the surgeon. Even very experienced clinicians face challenges: the shells can break if cut too thin, positioning may take a long time, and results can vary from patient to patient. Patients also report significant discomfort after surgery, including swelling, pain, and difficulty eating and speaking during recovery. In recent years, digital technology has begun to transform oral surgery. Using 3D imaging and computer design, it is now possible to create custom surgical guides and positioning jigs. These guides are printed with 3D printers and act like templates, helping surgeons cut bone in exactly the right size and shape, and place it precisely in the planned position. In implant dentistry, such guides are already used for the accurate placement of dental implants, and studies show they can make surgery faster and safer. However, little is known about whether these guides also improve patient comfort and recovery when used in bone grafting procedures such as the shell technique. This clinical trial has been designed to answer that question. It compares two groups of patients who need vertical bone augmentation before implant placement: Guided group: Patients treated with 3D-printed surgical guides for harvesting and positioning bone shells. Freehand group: Patients treated with the conventional freehand shell technique without guides. By studying both groups, the trial aims to determine whether guided surgery reduces pain, swelling, and recovery problems, and whether it saves time in the operating room. Most importantly, it seeks to put patients' voices at the center by focusing on patient-reported outcome measures (PROMs)-direct feedback from patients about how they feel after the procedure.
Official title: Clinical and Patient-reported Outcomes of Guided Versus Freehand Harvesting Of Positioning of Autogenous Bone Shells: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-02-02
Completion Date
2026-05-20
Last Updated
2026-09-16
Healthy Volunteers
Yes
Interventions
Free hand shell technique
Participants in this arm will undergo vertical ridge augmentation using the conventional freehand autogenous shell technique. Following preoperative CBCT assessment, the dimensions of the required graft will be determined. During surgery, the osteotomy outline at the external oblique ridge will be measured and marked manually. The autogenous cortical bone block will then be harvested, split into two thin cortical shells, and positioned and fixed at the recipient site freehand, without patient-specific surgical guides. Particulate autogenous bone will be placed between the shells, followed by tension-free primary closure.
Guided shell technique
Vertical ridge augmentation will be performed using a digitally planned, patient-specific guided workflow. CBCT and intraoral scan data will be registered to virtually plan the graft dimensions and configuration. A patient-specific harvesting guide and positioning/transfer guide will be designed and 3D-printed. The harvesting guide will direct bone-block retrieval from the external oblique ridge, while the positioning/transfer guide will assist extraoral assembly and stabilization of the cortical shells on a 3D-printed model and their subsequent transfer to the recipient site. The shells will be fixed using titanium microscrews, and the contained space will be filled with particulate autogenous bone.
Locations (1)
Shalash Implant Education
Cairo, Cairo Governorate, Egypt