Bone LossNCT06691516
Radiographic Assessment Of The Accuracy Of 3D Ridge Augmentation In Anterior Mandible Using Computer Guided Autogenous Cortical Shell Technique Versus Free Hand Technique
A study testing horizontal and vertical bone augmentation using computer guided cortical shell technique and free hand cortical shell technique in anterior 3d defect in people with Bone Loss, run by Cairo University.
Trial summary
this study aims to evaluate accuracy of fixation of the bone shells by a calculated distance which is always a challenging step for inexperienced surgeons to fix a cortical shells at the ideal position in the conventional protocol. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Bone Loss
- What is being tested?
- horizontal and vertical bone augmentation using computer guided cortical shell technique and free hand cortical shell technique in anterior 3d defect
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 21 Nov 2024to 1 Mar 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
- No healthy volunteers
- Adult
Who may be able to join
- Age ranges from 20-60 years. 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.
- Edentulous anterior mandible with a horizontally deficient alveolar ridge that is less than 3mm in width and with a vertically defect at least 3mm in height.
- The minimum number of missing teeth in the anterior mandible alveolar ridge is two adjacent teeth.
Who cannot join
- Intra-bony lesions (e.g., cysts) or infections (e.g., abscess) that may retard the osteotomy healing.
- Previous grafting procedures in the edentulous area
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- this study aims to evaluate accuracy of fixation of the bone shells by a calculated distance which is always a challenging step for inexperienced surgeons to fix a cortical shells at the ideal position in the conventional protocol. the fixation guides used to make the shells precisely fixed at the proper position and angulation the problem is if it fixed with insufficient distance with proposed volume loss leads to totally insufficient volume gain for future implant placement
- also to evaluate the efficacy of the CAD/CAM surgical guide during chin harvesting (harvesting guide ) procedure in reducing the risk of anatomical structure damage (mental neve) and patient morbidity with more accuracy compared with the standard technique and preserve the roots of the lower anterior teeth or any fracture to the inferior border of the mandible also allow to harvest the bone shells from the suitable area with cancellous bone which prevent bad split of the bone shells this trial versus free hand conventional cortical shell bone technique both harvested from symphysis area (chin),
- also to evaluate thickness of implanted bone shells , the thickness should be enough to preserve the graft(autograft 50% and xenograft 50%) between the buccal and lingual bone shells
- also aims to evaluate the vertical and horizontal bone augmentation achieved at the anterior mandible using computer-guided cortical shell bone technique.
Read the detailed description
this study aims to evaluate accuracy of fixation of the bone shells by a calculated distance which is always a challenging step for inexperienced surgeons to fix a cortical shells at the ideal position in the conventional protocol.
the fixation guides used to make the shells precisely fixed at the proper position and angulation the problem is if it fixed with insufficient distance with proposed volume loss leads to totally insufficient volume gain for future implant placement
- also to evaluate the efficacy of the CAD/CAM surgical guide during chin harvesting (harvesting guide ) procedure in reducing the risk of anatomical structure damage (mental neve) and patient morbidity with more accuracy compared with the standard technique and preserve the roots of the lower anterior teeth or any fracture to the inferior border of the mandible also allow to harvest the bone shells from the suitable area with cancellous bone which prevent bad split of the bone shells this trial versus free hand conventional cortical shell bone technique both harvested from symphysis area (chin),
- also to evaluate thickness of implanted bone shells , the thickness should be enough to preserve the graft(autograft 50% and xenograft 50%) between the buccal and lingual bone shells
- also aims to evaluate the vertical and horizontal bone augmentation achieved at the anterior mandible using computer-guided cortical shell bone technique.
- Conditions
- Bone Loss
- Being tested
- horizontal and vertical bone augmentation using computer guided cortical shell technique, free hand cortical shell technique in anterior 3d defect
- Keywords
- cortical shell , bone loss , computer guided
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
horizontal and vertical bone augmentation using computer guided cortical shell techniqueProcedure or surgery
Computer-guided cortical shell technique in anterior mandible 3d defect using bone harvesting guide and fixation guides
free hand cortical shell technique in anterior 3d defectProcedure or surgery
vertical and horizontal ridge augmentation in anterior mandible using free hand cortical shell technique
| Study group | Role | What they receive |
|---|---|---|
| computer guide cortical shell technique in anterior mandible 3d defect | Experimental | in study group there are bone harvesting guide and two fixation guides Receives: Procedure: horizontal and vertical bone augmentation using computer guided cortical shell technique |
| free hand cortical shell technique in anterior 3d defect | Active comparator | in control group, the bone harvesting and shells fixation will done with free hand technique Receives: Procedure: free hand cortical shell technique in anterior 3d defect |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of the implanted bone blocks
- depening on the superimposition between immediate postoperative CBCT scan over planning
- the maximum thickness of the implanted bone blocks (mimics)
Measured: immediately post operative
Secondary outcomes (1)
bone gain vertical and horizontal
CBCT volumetric change of deficient alveolar ridge after augmentation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start21 Nov 2024 (estimated)
- Primary completion26 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salah Sayed Ibrahim Elballal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691516
- Sponsor's protocol ID
- Computer guided cortical shell
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Assessment Of The Accuracy Of 3D Ridge Augmentation In Anterior Mandible Using Computer Guided Autogenous Cortical Shell Technique Versus Free Hand Technique
- ClinicalTrials.gov ID
- NCT06691516
- Acronym / sponsor ID
- Computer guided cortical shell
- Conditions
- Bone Loss
- Keywords
- cortical shell , bone loss , computer guided
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Nov 2024 (estimated)
- Primary completion
- 26 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 15 Nov 2024 (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.
- this study aims to evaluate accuracy of fixation of the bone shells by a calculated distance which is always a challenging step for inexperienced surgeons to fix a cortical shells at the ideal position in the conventional protocol. the fixation guides used to make the shells precisely fixed at the proper position and angulation the problem is if it fixed with insufficient distance with proposed volume loss leads to totally insufficient volume gain for future implant placement
- also to evaluate the efficacy of the CAD/CAM surgical guide during chin harvesting (harvesting guide ) procedure in reducing the risk of anatomical structure damage (mental neve) and patient morbidity with more accuracy compared with the standard technique and preserve the roots of the lower anterior teeth or any fracture to the inferior border of the mandible also allow to harvest the bone shells from the suitable area with cancellous bone which prevent bad split of the bone shells this trial versus free hand conventional cortical shell bone technique both harvested from symphysis area (chin),
- also to evaluate thickness of implanted bone shells , the thickness should be enough to preserve the graft(autograft 50% and xenograft 50%) between the buccal and lingual bone shells
- also aims to evaluate the vertical and horizontal bone augmentation achieved at the anterior mandible using computer-guided cortical shell bone technique.
Detailed description
this study aims to evaluate accuracy of fixation of the bone shells by a calculated distance which is always a challenging step for inexperienced surgeons to fix a cortical shells at the ideal position in the conventional protocol.
the fixation guides used to make the shells precisely fixed at the proper position and angulation the problem is if it fixed with insufficient distance with proposed volume loss leads to totally insufficient volume gain for future implant placement
- also to evaluate the efficacy of the CAD/CAM surgical guide during chin harvesting (harvesting guide ) procedure in reducing the risk of anatomical structure damage (mental neve) and patient morbidity with more accuracy compared with the standard technique and preserve the roots of the lower anterior teeth or any fracture to the inferior border of the mandible also allow to harvest the bone shells from the suitable area with cancellous bone which prevent bad split of the bone shells this trial versus free hand conventional cortical shell bone technique both harvested from symphysis area (chin),
- also to evaluate thickness of implanted bone shells , the thickness should be enough to preserve the graft(autograft 50% and xenograft 50%) between the buccal and lingual bone shells
- also aims to evaluate the vertical and horizontal bone augmentation achieved at the anterior mandible using computer-guided cortical shell bone technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computer guide cortical shell technique in anterior mandible 3d defect | Experimental | Procedure: horizontal and vertical bone augmentation using computer guided cortical shell techniquein study group there are bone harvesting guide and two fixation guides |
| free hand cortical shell technique in anterior 3d defect | Active comparator | Procedure: free hand cortical shell technique in anterior 3d defectin control group, the bone harvesting and shells fixation will done with free hand technique |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ranges from 20-60 years. 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.
- Edentulous anterior mandible with a horizontally deficient alveolar ridge that is less than 3mm in width and with a vertically defect at least 3mm in height.
- The minimum number of missing teeth in the anterior mandible alveolar ridge is two adjacent teeth.
Key exclusion criteria (2 listed)
- Intra-bony lesions (e.g., cysts) or infections (e.g., abscess) that may retard the osteotomy healing.
- Previous grafting procedures in the edentulous area
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 |
|---|---|---|
| horizontal and vertical bone augmentation using computer guided cortical shell techniqueComputer-guided cortical shell technique in anterior mandible 3d defect using bone harvesting guide and fixation guides | Procedure or surgery | computer guide cortical shell technique in anterior mandible 3d defect |
| free hand cortical shell technique in anterior 3d defectvertical and horizontal ridge augmentation in anterior mandible using free hand cortical shell technique | Procedure or surgery | free hand cortical shell technique in anterior 3d defect |
Primary outcome
accuracy of the implanted bone blocks
Time frame: immediately post operative
* depening on the superimposition between immediate postoperative CBCT scan over planning * the maximum thickness of the implanted bone blocks (mimics)
1 secondary outcome
bone gain vertical and horizontal
Time frame: 6 months
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 15 Nov 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing horizontal and vertical bone augmentation using computer guided cortical shell technique and free hand cortical shell technique in anterior 3d defect in people with Bone Loss, 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 4 inclusion and 2 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 15 Nov 2024. 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?
Contact Ahmed Salah Ahmed Salah Sayed (+20 010207395, ahmed.ibrahem@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of the implanted bone blocks (time frame: immediately post operative). 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 15 Nov 2024.