Horizontal Ridge DeficiencyNCT06942013
Radiographic Assessment of Guided Cortical Shell Technique for Horizontal Ridge Augmentation
A study testing Computer-Guided Autogenous Cortical Shell Technique (Study Group) in people with Horizontal Ridge Deficiency, run by Cairo University.
Trial summary
The protocol outlines a randomized clinical trial comparing two surgical techniques for horizontal ridge augmentation in the anterior mandible: Computer-Guided Autogenous Cortical Shell Technique (using a patient-specific guide for precise placement). Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Horizontal Ridge Deficiency
- What is being tested?
- Computer-Guided Autogenous Cortical Shell Technique (Study Group)
- 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
- No sites listed yet
- Study dates
- 1 May 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Anterior mandible with horizontal deficient alveolar ridge that is from 2 to 4 mm measured from the crest of the alveolar ridge buccolingually.
- Class IV and V according to Cawood and Howell classification.
- No sex predilection.
- Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
- The minimum number of missing teeth in the anterior mandible alveolar ridge is two adjacent teeth.
- Normal vertical dimension with normal inter-arch space.
Who cannot join
- • Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
- General contraindications to implant surgery.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
- Poor oral hygiene and motivation.
- Uncontrolled diabetes.
Show all 11Show fewer
- Pregnant or nursing females.
- Immunosuppressed or immunocompromised
- Heavy smokers
- Patients who undergo medication interfere with bone healing
- Previous grafting procedures in the edentulous area.
About this study
Official title: Radiographic Assessment of Cortical Shell Technique For Horizontal Ridge Augmentation In The Anterior Mandible Using Full Digital Workflow Versus Free Hand Protocol: A Randomized Clinical Trial
The protocol outlines a randomized clinical trial comparing two surgical techniques for horizontal ridge augmentation in the anterior mandible:
Computer-Guided Autogenous Cortical Shell Technique (using a patient-specific guide for precise placement).
Read more
Free-Hand Autogenous Cortical Shell Technique (traditional approach without a guiding template).
Key Points:
The study aims to determine which method provides better accuracy and bone volume stability.
Cone Beam CT scans (CBCT) will assess horizontal bone gain preoperatively and six months postoperatively.
The trial is conducted at Cairo University's Faculty of Dentistry. Participants: Patients with pure horizontal bone loss in the anterior mandible.
Outcomes:
Primary: Bone width gain in millimeters. Secondary: Accuracy of augmentation and surgical time.
Methodology:
The study group will use computer-designed surgical osteotomy guides to harvest and place bone grafts with improved precision.
The control group will rely on the conventional free-hand approach. Both groups will undergo bone grafting using autogenous cortical bone shells.
Data Collection \& Analysis:
Participants will be randomized and blinded. Data will be analyzed using statistical methods to compare effectiveness.
Read the detailed description
This randomized controlled trial evaluates the clinical effectiveness and surgical accuracy of a computer-guided versus a conventional free-hand approach for horizontal ridge augmentation in the anterior mandible using the autogenous cortical shell technique.
Participants presenting with horizontal alveolar bone deficiency in the anterior mandible are randomly assigned to one of two groups:
Study Group: A fully digital workflow is employed, including CBCT-based virtual planning and the use of 3D-printed, patient-specific stereolithographic guides for both bone harvesting and graft placement.
Control Group: The traditional free-hand technique is used without computer-guided assistance.
The study is designed to assess whether the digital, guided approach enhances horizontal bone gain, optimizes graft placement accuracy, reduces operative time, and lowers complication rates compared to the free-hand protocol.
The intervention involves preoperative 3D planning, surgical guide fabrication, and intraoperative bone harvesting and grafting. Both groups receive autogenous cortical bone blocks harvested from the mandibular symphysis and secured at the recipient site with mini screws. Bone particulate (autogenous + xenograft, 1:1 ratio) is used to augment volume.
Primary outcome is the amount of horizontal bone gain measured via CBCT superimposition at baseline and 6 months postoperatively. Secondary outcomes include surgical time, accuracy of graft placement, and incidence of postoperative complications such as pain, swelling, infection, dehiscence, or graft exposure.
This single-center, single-blinded equivalence trial uses a 1:1 randomization ratio. Ethical approval has been obtained, and participants provide informed consent prior to enrollment. The results are expected to inform surgical best practices and improve the predictability of mandibular ridge augmentation procedures.This randomized controlled trial evaluates the clinical effectiveness and surgical accuracy of a computer-guided versus a conventional free-hand approach for horizontal ridge augmentation in the anterior mandible using the autogenous cortical shell technique.
Participants presenting with horizontal alveolar bone deficiency in the anterior mandible are randomly assigned to one of two groups:
Study Group: A fully digital workflow is employed, including CBCT-based virtual planning and the use of 3D-printed, patient-specific stereolithographic guides for both bone harvesting and graft placement.
Control Group: The traditional free-hand technique is used without computer-guided assistance.
The study is designed to assess whether the digital, guided approach enhances horizontal bone gain, optimizes graft placement accuracy, reduces operative time, and lowers complication rates compared to the free-hand protocol.
The intervention involves preoperative 3D planning, surgical guide fabrication, and intraoperative bone harvesting and grafting. Both groups receive autogenous cortical bone blocks harvested from the mandibular symphysis and secured at the recipient site with mini screws. Bone particulate (autogenous + xenograft, 1:1 ratio) is used to augment volume.
Primary outcome is the amount of horizontal bone gain measured via CBCT superimposition at baseline and 6 months postoperatively. Secondary outcomes include accuracy of graft placement, and surgical time.
This single-center, single-blinded equivalence trial uses a 1:1 randomization ratio. Ethical approval has been obtained, and participants provide informed consent prior to enrollment. The results are expected to inform surgical best practices and improve the predictability of mandibular ridge augmentation procedures.
- Conditions
- Horizontal Ridge Deficiency
- Being tested
- Computer-Guided Autogenous Cortical Shell Technique (Study Group), Free-Hand Autogenous Cortical Shell Technique (Control group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Guided Autogenous Cortical Shell Technique (Study Group)Device
This study utilizes two patient-specific 3D-printed surgical guides to enhance precision in bone harvesting and fixation for horizontal ridge augmentation in the anterior mandible.
Chin Harvesting Guide
This tooth-supported guide is placed on the exposed mandibular symphysis to ensure accurate osteotomy cuts for harvesting a cortical bone shell.
It directs piezo drill cuts (superior, inferior, and vertical) to minimize errors and prevent damage to vital structures.
Bone Block Fixation Guide
After harvesting, this guide helps in precise fixation of the cortical shell onto the recipient site.
It includes pre-planned screw holes to ensure stable positioning of the graft and improve surgical accuracy.
These guides enhance precision, reduce surgical time, and improve graft stability, making the computer-guided technique superior to the traditional free-hand method.
Free-Hand Autogenous Cortical Shell Technique (Control group)Procedure or surgery
In this group, horizontal ridge augmentation of the anterior mandible is performed using a free-hand technique without computer-guided assistance. Autogenous cortical bone is harvested from the mandibular symphysis using a conventional osteotomy performed manually. The harvested cortical shell is adapted and fixated at the recipient site using titanium mini screws, based on the surgeon's clinical judgment and intraoperative assessment. Bone particulate grafting using a 1:1 ratio of autogenous bone and xenograft material is packed into the defect to enhance volume stability. This approach may result in increased variability in graft positioning, longer surgical time, and higher dependence on surgeon experience.
| Study group | Role | What they receive |
|---|---|---|
| Full Digital Workflow | Experimental | Study Group (Computer-Guided Autogenous Cortical Shell Technique)
Bone harvesting and fixation are done using patient-specific guides , chin harvesting guide and bone block fixation guide. Uses a 3D-printed, patient-specific surgical guide for precise bone harvesting and placement.
Piezo drill cuts are guided to ensure accurate osteotomy and graft positioning. The labial cortical shell is fixated using pre-planned screw holes for better stability.
Bone particulate grafting (autogenous + xenograft, 50:50) is packed into the defect.
Enhances accuracy, reduces surgical time, and minimizes complications Receives: Device: Computer-Guided Autogenous Cortical Shell Technique (Study Group) |
| Free Hand Protocol | Active comparator | Control Group (Free-Hand Autogenous Cortical Shell Technique)
Bone harvesting and fixation are done manually, relying on the surgeon's experience.
Osteotomy is performed free-hand, increasing the risk of inaccurate graft placement.
The labial cortical shell is manually fixated, potentially leading to misalignment.
Bone particulate grafting (autogenous + xenograft, 50:50) is used, similar to the study group.
Higher risk of human error, longer surgical time, and greater variability in outcomes Receives: Procedure: Free-Hand Autogenous Cortical Shell Technique (Control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar Ridge Horizontal Bone Gain
measure the amount of horizontal bone gain achieved at the anterior mandibular ridge following horizontal ridge augmentation using either the computer-guided autogenous cortical shell technique or the free-hand technique.
Measured: (CBCT) scans are taken preoperatively and 6 months postoperatively to evaluate bone changes. Superimposition of CBCT images is performed using Mimics 21.0 software (Materialise, Belgium) to assess bone augmentation
Secondary outcomes (2)
Accuracy of the Computer-assisted guide in the study group
CBCT superimposition is used to compare preoperative and postoperative ridge dimensions to determine how precisely the bone graft was placed.
Measurement Tool: CBCT scans analyzed with Mimics 21.0 software
Measured: Measured at: 6 months postoperatively using CBCT scans.
Intraoperative Time
The total surgical duration for each technique is recorded to assess time efficiency.
Measurement Tool: Stopwatch or surgical records. Unit of Measurement: Minutes.
Measured: During surgery by using a stopwatch.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horizontal Ridge DeficiencyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Type: Parallel, two arms, randomized controlled trial Allocation ratio: 1:1 Framework: Equivalence
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayar Momen El Khawass, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942013
- Sponsor's protocol ID
- Cortical Shell Technique
- Status last verified
- Apr 2025
- First submitted
- 16 Mar 2025
- Last updated
- 24 Apr 2025
- 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 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Assessment of Cortical Shell Technique For Horizontal Ridge Augmentation In The Anterior Mandible Using Full Digital Workflow Versus Free Hand Protocol: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06942013
- Acronym / sponsor ID
- Cortical Shell Technique
- Conditions
- Horizontal Ridge Deficiency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 24 Apr 2025 (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.
The protocol outlines a randomized clinical trial comparing two surgical techniques for horizontal ridge augmentation in the anterior mandible:
Computer-Guided Autogenous Cortical Shell Technique (using a patient-specific guide for precise placement).
Free-Hand Autogenous Cortical Shell Technique (traditional approach without a guiding template).
Key Points:
The study aims to determine which method provides better accuracy and bone volume stability.
Cone Beam CT scans (CBCT) will assess horizontal bone gain preoperatively and six months postoperatively.
The trial is conducted at Cairo University's Faculty of Dentistry. Participants: Patients with pure horizontal bone loss in the anterior mandible.
Outcomes:
Primary: Bone width gain in millimeters. Secondary: Accuracy of augmentation and surgical time.
Methodology:
The study group will use computer-designed surgical osteotomy guides to harvest and place bone grafts with improved precision.
The control group will rely on the conventional free-hand approach. Both groups will undergo bone grafting using autogenous cortical bone shells.
Data Collection \& Analysis:
Participants will be randomized and blinded. Data will be analyzed using statistical methods to compare effectiveness.
Detailed description
This randomized controlled trial evaluates the clinical effectiveness and surgical accuracy of a computer-guided versus a conventional free-hand approach for horizontal ridge augmentation in the anterior mandible using the autogenous cortical shell technique.
Participants presenting with horizontal alveolar bone deficiency in the anterior mandible are randomly assigned to one of two groups:
Study Group: A fully digital workflow is employed, including CBCT-based virtual planning and the use of 3D-printed, patient-specific stereolithographic guides for both bone harvesting and graft placement.
Control Group: The traditional free-hand technique is used without computer-guided assistance.
The study is designed to assess whether the digital, guided approach enhances horizontal bone gain, optimizes graft placement accuracy, reduces operative time, and lowers complication rates compared to the free-hand protocol.
The intervention involves preoperative 3D planning, surgical guide fabrication, and intraoperative bone harvesting and grafting. Both groups receive autogenous cortical bone blocks harvested from the mandibular symphysis and secured at the recipient site with mini screws. Bone particulate (autogenous + xenograft, 1:1 ratio) is used to augment volume.
Primary outcome is the amount of horizontal bone gain measured via CBCT superimposition at baseline and 6 months postoperatively. Secondary outcomes include surgical time, accuracy of graft placement, and incidence of postoperative complications such as pain, swelling, infection, dehiscence, or graft exposure.
This single-center, single-blinded equivalence trial uses a 1:1 randomization ratio. Ethical approval has been obtained, and participants provide informed consent prior to enrollment. The results are expected to inform surgical best practices and improve the predictability of mandibular ridge augmentation procedures.This randomized controlled trial evaluates the clinical effectiveness and surgical accuracy of a computer-guided versus a conventional free-hand approach for horizontal ridge augmentation in the anterior mandible using the autogenous cortical shell technique.
Participants presenting with horizontal alveolar bone deficiency in the anterior mandible are randomly assigned to one of two groups:
Study Group: A fully digital workflow is employed, including CBCT-based virtual planning and the use of 3D-printed, patient-specific stereolithographic guides for both bone harvesting and graft placement.
Control Group: The traditional free-hand technique is used without computer-guided assistance.
The study is designed to assess whether the digital, guided approach enhances horizontal bone gain, optimizes graft placement accuracy, reduces operative time, and lowers complication rates compared to the free-hand protocol.
The intervention involves preoperative 3D planning, surgical guide fabrication, and intraoperative bone harvesting and grafting. Both groups receive autogenous cortical bone blocks harvested from the mandibular symphysis and secured at the recipient site with mini screws. Bone particulate (autogenous + xenograft, 1:1 ratio) is used to augment volume.
Primary outcome is the amount of horizontal bone gain measured via CBCT superimposition at baseline and 6 months postoperatively. Secondary outcomes include accuracy of graft placement, and surgical time.
This single-center, single-blinded equivalence trial uses a 1:1 randomization ratio. Ethical approval has been obtained, and participants provide informed consent prior to enrollment. The results are expected to inform surgical best practices and improve the predictability of mandibular ridge augmentation procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Type: Parallel, two arms, randomized controlled trial Allocation ratio: 1:1 Framework: Equivalence
| Arm | Type | Receives |
|---|---|---|
| Full Digital Workflow | Experimental | Device: Computer-Guided Autogenous Cortical Shell Technique (Study Group)Study Group (Computer-Guided Autogenous Cortical Shell Technique) Bone harvesting and fixation are done using patient-specific guides , chin harvesting guide and bone block fixation guide. Uses a 3D-printed, patient-specific surgical guide for precise bone harvesting and placement. Piezo drill cuts are guided to ensure accurate osteotomy and graft positioning. The labial cortical shell is fixated using pre-planned screw holes for better stability. Bone particulate grafting (autogenous + xenograft, 50:50) is packed into the defect. Enhances accuracy, reduces surgical time, and minimizes complications |
| Free Hand Protocol | Active comparator | Procedure: Free-Hand Autogenous Cortical Shell Technique (Control group)Control Group (Free-Hand Autogenous Cortical Shell Technique) Bone harvesting and fixation are done manually, relying on the surgeon's experience. Osteotomy is performed free-hand, increasing the risk of inaccurate graft placement. The labial cortical shell is manually fixated, potentially leading to misalignment. Bone particulate grafting (autogenous + xenograft, 50:50) is used, similar to the study group. Higher risk of human error, longer surgical time, and greater variability in outcomes |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Anterior mandible with horizontal deficient alveolar ridge that is from 2 to 4 mm measured from the crest of the alveolar ridge buccolingually.
Key exclusion criteria (11 listed)
- • Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
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 |
|---|---|---|
| Computer-Guided Autogenous Cortical Shell Technique (Study Group)This study utilizes two patient-specific 3D-printed surgical guides to enhance precision in bone harvesting and fixation for horizontal ridge augmentation in the anterior mandible. Chin Harvesting Guide This tooth-supported guide is placed on the exposed mandibular symphysis to ensure accurate osteotomy cuts for harvesting a cortical bone shell. It directs piezo drill cuts (superior, inferior, and vertical) to minimize errors and prevent damage to vital structures. Bone Block Fixation Guide After harvesting, this guide helps in precise fixation of the cortical shell onto the recipient site. It includes pre-planned screw holes to ensure stable positioning of the graft and improve surgical accuracy. These guides enhance precision, reduce surgical time, and improve graft stability, making the computer-guided technique superior to the traditional free-hand method. | Device | Full Digital Workflow |
| Free-Hand Autogenous Cortical Shell Technique (Control group)In this group, horizontal ridge augmentation of the anterior mandible is performed using a free-hand technique without computer-guided assistance. Autogenous cortical bone is harvested from the mandibular symphysis using a conventional osteotomy performed manually. The harvested cortical shell is adapted and fixated at the recipient site using titanium mini screws, based on the surgeon's clinical judgment and intraoperative assessment. Bone particulate grafting using a 1:1 ratio of autogenous bone and xenograft material is packed into the defect to enhance volume stability. This approach may result in increased variability in graft positioning, longer surgical time, and higher dependence on surgeon experience. | Procedure or surgery | Free Hand Protocol |
Primary outcome
Alveolar Ridge Horizontal Bone Gain
Time frame: (CBCT) scans are taken preoperatively and 6 months postoperatively to evaluate bone changes. Superimposition of CBCT images is performed using Mimics 21.0 software (Materialise, Belgium) to assess bone augmentation
measure the amount of horizontal bone gain achieved at the anterior mandibular ridge following horizontal ridge augmentation using either the computer-guided autogenous cortical shell technique or the free-hand technique.
2 secondary outcomes
Accuracy of the Computer-assisted guide in the study group
Time frame: Measured at: 6 months postoperatively using CBCT scans.
Intraoperative Time
Time frame: During surgery by using a stopwatch.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-Guided Autogenous Cortical Shell Technique (Study Group) in people with Horizontal Ridge Deficiency, run by Cairo University.
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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Alveolar Ridge Horizontal Bone Gain (time frame: (CBCT) scans are taken preoperatively and 6 months postoperatively to evaluate bone changes. Superimposition of CBCT images is performed using Mimics 21.0 software (Materialise, Belgium) to assess bone augmentation). 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 24 Apr 2025.