Clinical and Patient-reported Outcomes of Guided Versus Freehand Harvesting Of Positioning of Autogenous Bone Shells

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.

Conditions

• Alveolar Bone Loss in Mandible
• Guided Bone Regeneration
• Dental Implant

Interventions

DEVICE

Free hand shell technique

In this group, a 3D scan of the patient's jaws will be taken. Using specialized computer software, the surgeon will design custom guides for harvesting the bone shell and positioning it at the recipient site. These guides are then 3D-printed. During surgery, the guides fit onto the patient's jaw and direct the cutting and placement of the bone shell with high precision. This process is expected to shorten the procedure and reduce errors.

DEVICE

Guided shell technique

Participants in this arm will undergo vertical ridge augmentation using the conventional freehand shell technique. Thin cortical bone plates will be harvested manually from the donor site and positioned at the recipient site without guides, relying on surgeon experience and judgment. The shells will be fixed with microscrews, filled with autogenous bone chips, and covered with a resorbable collagen membrane before suturing. This represents the current standard method of care.

Sponsors & Collaborators

• Shalash Dental education

  lead OTHER

Principal Investigators

• Mahmoud shalash, PhD · National Research Centre Cairo Egypt

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2026-02-15

Completion

2026-03-01

Countries

• Egypt

Study Locations