Alveolar Bone Loss in MandibleguidedNCT07381608
Clinical and Patient-reported Outcomes of Guided Versus Freehand Harvesting Of Positioning of Autogenous Bone Shells
A study testing Free hand shell technique and Guided shell technique in people with Alveolar Bone Loss in Mandible and Guided Bone Regeneration, run by Shalash Dental education at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss in Mandible, Guided Bone Regeneration, Dental Implant
- What is being tested?
- Free hand shell technique and Guided shell technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2026to 20 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Free hand shell technique, Guided shell technique
- Keywords
- alveolar ridge augmentation, guided bone regeneration, dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free hand shell techniqueProcedure or surgery
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 techniqueDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Guided shell technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (2)
analgesic intake
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.
Measured: 7 days
Surgical time
The amount of time for the procedure will be recorded in minutes during the intervention and the control procedures.
Measured: on the day of the surgery ( T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start2 Feb 2026
- Primary completion28 Mar 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone Loss in MandibleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm parallel randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shalash Dental education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud shalash, PhD, Principal investigator, National Research Centre Cairo Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381608
- Sponsor's protocol ID
- 25-055
- Acronym
- guided
- Status last verified
- Sep 2026
- First submitted
- 17 Jan 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Patient-reported Outcomes of Guided Versus Freehand Harvesting Of Positioning of Autogenous Bone Shells: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07381608
- Acronym / sponsor ID
- guided / 25-055
- Keywords
- alveolar ridge augmentation, guided bone regeneration, dental implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shalash Dental educationUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 28 Mar 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two arm parallel randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Free hand | Active comparator | Procedure: Free hand shell techniqueParticipants 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. |
| Guided shell technique | Experimental | Device: Guided shell techniqueParticipants 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free hand shell techniqueParticipants 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. | Procedure or surgery | Free hand |
| Guided shell techniqueVertical 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. | Device | Guided shell technique |
Primary outcome
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.
2 secondary outcomes
analgesic intake
Time frame: 7 days
Surgical time
Time frame: on the day of the surgery ( T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud shalash, PhD principal investigator
National Research Centre Cairo Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free hand shell technique and Guided shell technique in people with Alveolar Bone Loss in Mandible and Guided Bone Regeneration, run by Shalash Dental education at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale for Pain (0-10) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.