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

September 3, 2026 updated by: Shalash Dental education

Clinical and Patient-reported Outcomes of Guided Versus Freehand Harvesting Of Positioning of Autogenous Bone Shells: a Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Why This Trial is Needed. Bone augmentation surgeries are elective procedures. Patients choose them to improve their quality of life through implant-supported teeth. Because these surgeries are optional, patients' comfort, recovery, and satisfaction are especially important. Traditional studies often measure only technical outcomes, such as how much bone is gained or whether implants survive in the long term. While these outcomes are essential, they do not tell the whole story. A patient may have a technically successful bone graft but still feel the experience was very painful or difficult, which could reduce trust in dental care.

The guided shell technique holds promise for reducing patient suffering. By making surgery quicker and more precise, it might limit tissue trauma and shorten healing time. Yet, until now, no high-quality randomized controlled trial (RCT) has compared guided versus freehand shell grafting from the patient's perspective. This lack of evidence is a gap that needs to be filled so that patients and clinicians can make informed choices. If guided surgery proves superior, it could become the new standard of care, ensuring safer and more comfortable treatment for people needing implants.

Purpose of the Study

The main goal of this study is to compare the patient-reported outcomes between guided and freehand autogenous shell grafting. Specifically, the trial will investigate:

How much pain, swelling, bruising, difficulty chewing, and limited mouth opening (trismus) patients experience after surgery.

Whether patients feel more comfortable overall when treated with guides. How many painkiller tablets do patients need during the first week after surgery? How long does the operation take in each group? Whether complications such as infection or graft failure occur more often in one method than the other.

By looking at these factors, the trial will provide a complete picture of not just how well the bone graft works, but how patients actually feel throughout recovery.

Study Design: This research is a prospective randomized controlled clinical trial. That means patients are enrolled before the surgery, randomly assigned to one of two groups, and followed over time to measure outcomes. Randomization is important because it ensures that the two groups are similar at the start, so any differences in results can be attributed to the surgical method rather than patient characteristics.

The trial will be conducted at the Shalash Dental Centre clinic.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11865
        • Shalash Implant Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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%.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Free hand
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
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale for Pain (0-10)
Time Frame: 7 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
analgesic intake
Time Frame: 7 days
Analgesic intake will be recorded by the patient as the number of tablets and frequency, and will be measured in mg totally after 1 week, the higher the number of mg of analgesic would indicate severe pain and discomfort while low analgesic intake would indicate low pain.
7 days
Surgical time
Time Frame: on the day of the surgery ( T1)
The amount of time for the procedure will be recorded in minutes during the intervention and the control procedures.
on the day of the surgery ( T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shalash Dental education

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mahmoud shalash, PhD, National Research Centre Cairo Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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