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

NCT07381608 | Not Yet Recruiting

• 1 other identifier: 25-055
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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. 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.

Device: Free hand shell technique

Guided shell technique

EXPERIMENTAL

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.

Device: Guided shell technique

Interventions

Free hand shell technique DEVICE

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.

Free hand

Guided shell technique DEVICE

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.

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 (2)

Shalash Implant Education

Cairo, Cairo Governorate, 11865, Egypt

Location

Shalash Implant Education

Cairo, Cairo Governorate, 11865, Egypt

Location

Study Officials

• Mahmoud shalash, PhD

  National Research Centre Cairo Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mihad Ibrahim, M.Sc

CONTACT

00201006151498; mihad.farouk@hotmail.com

Mihad Ibrahim, M.Sc

CONTACT

00201008551124; mihad.farouk@hotmail.com

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 1, 2026
• Primary Completion: February 15, 2026
• Study Completion: March 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)