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

NCT07381608 | Completed

• 1 other identifier: 25-055
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

alveolar ridge augmentation; guided bone regeneration; dental implant

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale for Pain (0-10)

  The Visual Analogue Scale for Pain is a Likert scale (0-10) in which the patient rates pain in response to prespecified questions (Pilowsky and Kaufman, 1965). This is a standard tool for recording subjective measurements, such as pain, into a measurable outcome that can be compared across subjects enrolled in the study. On this scale 0 means there is no pain felt, and 10 is the worst possible pain felt. Lower scores indicate lower pain and higher scores indicate severe pain.

  7 days

Secondary Outcomes (2)

• analgesic intake

  7 days

• Surgical time

  on the day of the surgery ( T1)

Study Arms (2)

Free hand

ACTIVE COMPARATOR

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.

Procedure: Free hand shell technique

Guided shell technique

EXPERIMENTAL

Participants in this arm will undergo vertical ridge augmentation using a digitally guided autogenous shell technique. CBCT and intraoral scan data will be combined for virtual planning of the required graft. Patient-specific surgical guides will be designed and 3D-printed to guide bone-block harvesting and shell positioning. During surgery, the harvesting guide will direct retrieval of the autogenous bone block from the external oblique ridge. After splitting, the cortical shells will be assembled and stabilized extraorally on a 3D-printed model using a positioning/transfer guide and subsequently transferred to the recipient site for fixation. Particulate autogenous bone will be placed between the shells, followed by tension-free primary closure

Device: Guided shell technique

Interventions

Free hand shell technique PROCEDURE

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.

Free hand

Guided shell technique DEVICE

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.

Guided shell technique

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-99years. Classified as American Society of Anesthesiologists (ASA) I or II.
• Partial edentulism (missing teeth) requiring ≥4 mm vertical ridge augmentation.
• Presence of a suitable intraoral donor site for bone harvesting.
• Good oral hygiene, with Full Mouth Plaque Score (FMPS) \< 25%.

You may not qualify if:

• Systemic contraindications to oral surgery (uncontrolled systemic disease). -History of head or neck radiotherapy.
• Current or past use of bisphosphonates or other medications affecting bone healing.
• Smokers of more than 10 cigarettes per day.
• Pregnant or breastfeeding women.
• Presence of active oral infection at the surgical site.
• Untreated periodontal disease.

Sponsors & Collaborators

• Shalash Dental education: lead

Study Sites (1)

Shalash Implant Education

Cairo, Cairo Governorate, 11865, Egypt

Location

Study Officials

• Mahmoud shalash, PhD

  National Research Centre Cairo Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two arm parallel randomized controlled clinical trial

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: February 2, 2026
• Study Start: February 2, 2026
• Primary Completion: March 28, 2026
• Study Completion: May 20, 2026
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)