Alveolar Bone ResorptionNCT05311332
Computer-guided vs. Conventional Cortical Shell Technique for Horizontal Augmentation
A study testing Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin and Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin using patient specific surgical guide then positioned with another guide in people with Alveolar Bone Resorption and Horizontal Ridge Deficiency, run by Future University in Egypt at 1 site in Egypt.
Trial summary
this study aims to evaluate horizontal bone augmentation achieved at the anterior maxilla using computer-guided cortical shell bone technique and accuracy of fixation of the bone shell away from the atrophic ridge by a calculated distance which is always a challenging step for inexperienced surgeons to fix a cortical… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption, Horizontal Ridge Deficiency
- What is being tested?
- Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin and Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin using patient specific surgical guide then positioned with another guide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Oct 2021to 1 Nov 2022
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient free from any systemic condition.
- Edentulous anterior maxilla with a horizontal deficient alveolar ridge that is less than 4 mm measured from outer buccal cortices to outer palatal cortices.
- Highly motivated patients are willing for the surgical procedure and follow-up, with informed consent.
Who cannot join
- Intra bony lesions (e.g. Cysts) or infections(e.g.abcess) that may retard the osteotomy healing.
- Medically compromised patients.
- Uncooperative patients.
- Patients with any diseases or taking any medications that compromise bone healing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Horizontal Bone Gain Using Computer-guided vs. Conventional Cortical Shell Technique for Horizontal Maxillary Alveolar Ridge Augmentation
this study aims to evaluate horizontal bone augmentation achieved at the anterior maxilla using computer-guided cortical shell bone technique and accuracy of fixation of the bone shell away from the atrophic ridge by a calculated distance which is always a challenging step for inexperienced surgeons to fix a cortical shell at the ideal position in the conventional protocol it was never guided to be 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 procedures in reducing the risk of anatomical structure damage and patient morbidity with more accuracy compared with the standard technique. this trial versus free hand conventional cortical shell bone technique both harvested from symphysis area (chin).
Read the detailed description
Tooth extraction may be due to a variety of causes such as badly decayed, periodontal disease, and trauma whatever the reason tooth loss is always followed by loss of masticatory force and muscle stimulation to the alveolar bone so according to Wolff's Law (Wolff, 1892) loss of mechanical stimulation is followed by the reduction of bone mass.
Several surgical protocols have been used to manage horizontal maxillary alveolar bone atrophy such as bone splitting and bone spreading techniques with or without filling the created space, onlay bone graft, guided bone regeneration using resorbable or non-resorbable membrane, distraction osteogenesis, and shell bone block technique which use a thin cortical bone shell to reshape the atrophied ridge and protect the particulate bone graft.
Despite the popularity of this technique, it usually requires high surgical skills, prolonged intra-operative time, and unfortunately has some technical drawbacks. Such as lack of anatomical guidance during bone harvesting which may lead to injury to the important vital structure and lack of guidance during fixation may lead to improperly positioned, tilted, or rotated shell or even leaving an undesired distance between the shell and deficient ridge
With the increasing use of cone-beam computed tomography (CBCT), intra and extra oral scanner for patient data acquisition, and complete digital workflow in clinical practice and it is rapidly becoming the standard of care in dentistry. Regarding bone augmentation as preparation for future implant placement. computer-aided surgery has been an innovation that enables clinicians to have firm and accurate treatment planning. Also, milling or 3D printing methods allow variable techniques for the fabrication of surgical templates.
This study aims to fully digitalize such technique using patient-specific surgical guides to allow for accurate graft harvesting and positioning and to minimize intraoperative time and complications associated with this procedure
- Being tested
- Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin, Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin using patient specific surgical guide then positioned with another guide
- Keywords
- alveolar ridge deficiency, computer guided surgery, chin graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chinProcedure or surgery
Augmentation of horizontal deficient anterior maxilla using the conventional protocol of cortical shell technique
Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin using patient specific surgical guide then positioned with another guideProcedure or surgery
using a patient-specific surgical guide to harvest bone cortical shell from the chin and another patient-specific surgical guide to fix it in the atrophied maxillary anterior area
| Study group | Role | What they receive |
|---|---|---|
| Anterior maxillary bone augmentation using computer guided autogenous cortical shell technique. | Experimental | a patient-specific guide was used to harvest a chin cortical shell which was also prepared and positioned at the (anterior horizontally atrophied maxilla) recipient site using another patient-specific positioning guide. Receives: Procedure: Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin using patient specific surgical guide then positioned with another guide |
| Anterior maxilla bone augmentation using free hand autogenous cortical shell technique. | Active comparator | the horizontally atrophic anterior maxilla was augmented with a cortical shell technique the bone was harvested from the chin without a patient-specific guide. Receives: Procedure: Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar ridge horizontal net bone gain
volumetric change of deficient alveolar ridge after augmentation
Measured: 4 months
Secondary outcomes (2)
surgical procedure accuracy
depening on the superimposition between immediate postoperative CBCT scan over planning
Measured: immediate post operative
intraoperation time
duration of surgery
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start13 Oct 2021
- Primary completion20 Aug 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone ResorptionStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ayman, Future University in Egypt
- Investigators
- Dina Ayman Fayek, BDS, Principal investigator, teaching assistant oral and maxillofacial department future university in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311332
- Sponsor's protocol ID
- FUE.REC (23)\11-2021
- Status last verified
- Feb 2023
- First submitted
- 27 Mar 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the data will be available from the corresponding author upon resonable request.
Publications
Ayman D, Shawky M, Aly LAA, Mounir M, Zekry AKA. Bone gain and accuracy assessment of computer-guided workflow for horizontal augmentation of atrophic anterior maxilla with symphyseal cortical plates: a randomized controlled trial. BMC Oral Health. 2025 Jul 2;25(1):1039. doi: 10.1186/s12903-025-06415-2.
PubMed 40604890
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Horizontal Bone Gain Using Computer-guided vs. Conventional Cortical Shell Technique for Horizontal Maxillary Alveolar Ridge Augmentation
- ClinicalTrials.gov ID
- NCT05311332
- Acronym / sponsor ID
- FUE.REC (23)\11-2021
- Keywords
- alveolar ridge deficiency, computer guided surgery, chin graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 5 Apr 2022 (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 horizontal bone augmentation achieved at the anterior maxilla using computer-guided cortical shell bone technique and accuracy of fixation of the bone shell away from the atrophic ridge by a calculated distance which is always a challenging step for inexperienced surgeons to fix a cortical shell at the ideal position in the conventional protocol it was never guided to be 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 procedures in reducing the risk of anatomical structure damage and patient morbidity with more accuracy compared with the standard technique. this trial versus free hand conventional cortical shell bone technique both harvested from symphysis area (chin).
Detailed description
Tooth extraction may be due to a variety of causes such as badly decayed, periodontal disease, and trauma whatever the reason tooth loss is always followed by loss of masticatory force and muscle stimulation to the alveolar bone so according to Wolff's Law (Wolff, 1892) loss of mechanical stimulation is followed by the reduction of bone mass.
Several surgical protocols have been used to manage horizontal maxillary alveolar bone atrophy such as bone splitting and bone spreading techniques with or without filling the created space, onlay bone graft, guided bone regeneration using resorbable or non-resorbable membrane, distraction osteogenesis, and shell bone block technique which use a thin cortical bone shell to reshape the atrophied ridge and protect the particulate bone graft.
Despite the popularity of this technique, it usually requires high surgical skills, prolonged intra-operative time, and unfortunately has some technical drawbacks. Such as lack of anatomical guidance during bone harvesting which may lead to injury to the important vital structure and lack of guidance during fixation may lead to improperly positioned, tilted, or rotated shell or even leaving an undesired distance between the shell and deficient ridge
With the increasing use of cone-beam computed tomography (CBCT), intra and extra oral scanner for patient data acquisition, and complete digital workflow in clinical practice and it is rapidly becoming the standard of care in dentistry. Regarding bone augmentation as preparation for future implant placement. computer-aided surgery has been an innovation that enables clinicians to have firm and accurate treatment planning. Also, milling or 3D printing methods allow variable techniques for the fabrication of surgical templates.
This study aims to fully digitalize such technique using patient-specific surgical guides to allow for accurate graft harvesting and positioning and to minimize intraoperative time and complications associated with this procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior maxillary bone augmentation using computer guided autogenous cortical shell technique. | Experimental | Procedure: Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin using patient specific surgical guide then positioned with another guidea patient-specific guide was used to harvest a chin cortical shell which was also prepared and positioned at the (anterior horizontally atrophied maxilla) recipient site using another patient-specific positioning guide. |
| Anterior maxilla bone augmentation using free hand autogenous cortical shell technique. | Active comparator | Procedure: Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chinthe horizontally atrophic anterior maxilla was augmented with a cortical shell technique the bone was harvested from the chin without a patient-specific guide. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient free from any systemic condition.
- Edentulous anterior maxilla with a horizontal deficient alveolar ridge that is less than 4 mm measured from outer buccal cortices to outer palatal cortices.
- Highly motivated patients are willing for the surgical procedure and follow-up, with informed consent.
Key exclusion criteria (4 listed)
- Intra bony lesions (e.g. Cysts) or infections(e.g.abcess) that may retard the osteotomy healing.
- Medically compromised patients.
- Uncooperative patients.
- Patients with any diseases or taking any medications that compromise bone 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 |
|---|---|---|
| Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chinAugmentation of horizontal deficient anterior maxilla using the conventional protocol of cortical shell technique | Procedure or surgery | Anterior maxilla bone augmentation using free hand autogenous cortical shell technique. |
| Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin using patient specific surgical guide then positioned with another guideusing a patient-specific surgical guide to harvest bone cortical shell from the chin and another patient-specific surgical guide to fix it in the atrophied maxillary anterior area | Procedure or surgery | Anterior maxillary bone augmentation using computer guided autogenous cortical shell technique. |
Primary outcome
Alveolar ridge horizontal net bone gain
Time frame: 4 months
volumetric change of deficient alveolar ridge after augmentation
2 secondary outcomes
surgical procedure accuracy
Time frame: immediate post operative
intraoperation time
Time frame: at time of surgery
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 15 Feb 2023.
- Derived from this study: PubMed 40604890Ayman D, Shawky M, Aly LAA, Mounir M, Zekry AKA. Bone gain and accuracy assessment of computer-guided workflow for horizontal augmentation of atrophic anterior maxilla with symphyseal cortical plates: a randomized controlled trial. BMC Oral Health. 2025 Jul 2;25(1):1039. doi: 10.1186/s12903-025-06415-2.
- Individual participant dataSharing planned: Undecided. the data will be available from the corresponding author upon resonable request.
Related trials for Alveolar Bone Resorption
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Alveolar Ridge Augmentation, Bone Substitutes
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Autogenous Mesenchymal Stem Cell Culture-Derived Signalling Molecules as Enhancers of Bone Formation in Bone Grafting
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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.
Dina Ayman Fayek, BDS principal investigator
teaching assistant oral and maxillofacial department future university in 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 Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin and Augmentation of horizontal deficient anterior maxilla with a cortical shell harvested from a chin using patient specific surgical guide then positioned with another guide in people with Alveolar Bone Resorption and Horizontal Ridge Deficiency, run by Future University in Egypt 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 3 inclusion and 4 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 15 Feb 2023. 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?
Alveolar ridge horizontal net bone gain (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05311332, which also lists 1 linked publication.
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 Feb 2023; AzTrials last refreshed its copy on 28 Oct 2026.