Alveolar Bone LossNCT07365852
Accuracy Assessment of Chin Graft for Ridge Augmentation Using Tooth-supported Guide Versus Free Hand Technique
A study testing 3D ridge augmentation using tooth-supported patient-specific guide in people with Alveolar Bone Loss, run by Cairo University at 1 site in Egypt.
Trial summary
This study compares the accuracy of osteotomies positions using patient specific guides for onlay bone shells harvested from the chin then the graft positioning for 3D upper anterior ridge augmentation using patient-specific tooth-supported guide versus free hand technique Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- 3D ridge augmentation using tooth-supported patient-specific guide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 30 Sep 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Anterior maxilla with horizontal deficient alveolar ridge that is from 2 to 4 mm measured from the crest of the alveolar ridge buccolingually, combined with vertical deficiency.
- Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
- Both genders males and females will be included
- 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 10Show fewer
- Pregnant or nursing females.
- Immunosuppressed or immunocompromised
- Heavy smokers
- Patients undergo medication interfere with bone healing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy Assessment of Symphyseal Onlay Bone Grafting for 3D Maxillary Ridge Augmentation Using Tooth-supported Patient-specific Surgical Guide Versus Free Hand Technique: A Randomized Controlled Trial
This study compares the accuracy of osteotomies positions using patient specific guides for onlay bone shells harvested from the chin then the graft positioning for 3D upper anterior ridge augmentation using patient-specific tooth-supported guide versus free hand technique
Read the detailed description
In this study the tooth-supported stereolithographic guiding template is proposed to allow accurate onlay grafting of labial and palatal mono-cortical shells simultaneously after harvesting using computer-designed patient-specific surgical osteotomy guide. This customized osteotomy guide should provide accurate harvesting of autogenous bone blocks from chin area which also provides suitable contour with the anterior ridge area. This computer assisted surgery is supposed to help in decreasing the operation time, thus decreasing the devascularization time to the bone graft. Thus, it helps for increased accuracy to increase three-dimensional bone gain and decrease morbidity of donor site while gaining the maximum available bone volume. Tooth-supported graft placement guide provides reproducible and convenient design without the need of high surgical skills as well.
- Conditions
- Alveolar Bone Loss
- Being tested
- 3D ridge augmentation using tooth-supported patient-specific guide
- Keywords
- ridge augmentation, onlay grafting, tooth-supported guide, patient-specific guide, maxillary bone augmentation, chin graft
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D ridge augmentation using tooth-supported patient-specific guideProcedure or surgery
In this study computer-designed patient-specific surgical osteotomy guide should provide accurate harvesting of autogenous bone blocks from chin area.Then, graft placement will be done using patient-specific tooth-supported guide in upper anterior deficient ridge and fixation using 2 micro screws labially and one through and through for the palatal shell.
| Study group | Role | What they receive |
|---|---|---|
| Tooth-supported Patient-specific Surgical Guide | Experimental | In this study computer-designed patient-specific surgical osteotomy guide provides accurate harvesting of autogenous bone blocks from chin area.Then, graft placement will be done using patient-specific tooth-supported guide in upper anterior deficient ridge and fixation using 2 micro screws labially and one through and through for the palatal shell. Receives: Procedure: 3D ridge augmentation using tooth-supported patient-specific guide |
| Free hand technique | Active comparator | The cortical bone harvested from chin area without surgical guide, then the non-guided mono-cortical bone block grafting will be fixed on the ridge labially using 2 micro screws and one through and through for the palatal shell. Receives: Procedure: 3D ridge augmentation using tooth-supported patient-specific guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar ridge width bone gain
measures will be obtained from CT scan in millimetres
Measured: 4 months
Secondary outcomes (1)
Alveolar ridge vertical bone gain
measures will be obtained from CT scan in millimetres
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jul 2024
- Primary completion1 Apr 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alveolar 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wesam Sami Hassan Ali, Cairo University
- Investigators
- Wesam Sami, Bachelor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365852
- Sponsor's protocol ID
- 4596
- Status last verified
- Jan 2026
- First submitted
- 25 Jun 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aloy-Prosper A, Carramolino-Cuellar E, Penarrocha-Oltra D, Soto-Penaloza D, Penarrocha-Diago M. Intraoral onlay block bone grafts versus cortical tenting technique on alveolar ridge augmentations: a systematic review. Med Oral Patol Oral Cir Bucal. 2022 Mar 1;27(2):e181-e190. doi: 10.4317/medoral.25169.
PubMed 35218647Cansiz E, Haq J, Manisali M, Cakarer S, Gultekin BA. Long-term evaluation of three-dimensional volumetric changes of augmented severely atrophic maxilla by anterior iliac crest bone grafting. J Stomatol Oral Maxillofac Surg. 2020 Dec;121(6):665-671. doi: 10.1016/j.jormas.2019.11.004. Epub 2020 Feb 8.
PubMed 32045687Chen ST, Beagle J, Jensen SS, Chiapasco M, Darby I. Consensus statements and recommended clinical procedures regarding surgical techniques. Int J Oral Maxillofac Implants. 2009;24 Suppl:272-8. No abstract available.
PubMed 19885450De Stavola L, Fincato A, Bressan E, Gobbato L. Results of Computer-Guided Bone Block Harvesting from the Mandible: A Case Series. Int J Periodontics Restorative Dent. 2017 Jan/Feb;37(1):e111-e119. doi: 10.11607/prd.2721.
PubMed 27977816Naishlos S, Zenziper E, Zelikman H, Nissan J, Mizrahi S, Chaushu G, Matalon S, Chaushu L. Esthetic Assessment Succeeding Anterior Atrophic Maxilla Augmentation with Cancellous Bone-Block Allograft and Late Restoration Loading. J Clin Med. 2021 Oct 9;10(20):4635. doi: 10.3390/jcm10204635.
PubMed 34682757
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Assessment of Symphyseal Onlay Bone Grafting for 3D Maxillary Ridge Augmentation Using Tooth-supported Patient-specific Surgical Guide Versus Free Hand Technique: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07365852
- Acronym / sponsor ID
- 4596
- Conditions
- Alveolar Bone Loss
- Keywords
- ridge augmentation, onlay grafting, tooth-supported guide, patient-specific guide, maxillary bone augmentation, chin graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 26 Jan 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.
This study compares the accuracy of osteotomies positions using patient specific guides for onlay bone shells harvested from the chin then the graft positioning for 3D upper anterior ridge augmentation using patient-specific tooth-supported guide versus free hand technique
Detailed description
In this study the tooth-supported stereolithographic guiding template is proposed to allow accurate onlay grafting of labial and palatal mono-cortical shells simultaneously after harvesting using computer-designed patient-specific surgical osteotomy guide. This customized osteotomy guide should provide accurate harvesting of autogenous bone blocks from chin area which also provides suitable contour with the anterior ridge area. This computer assisted surgery is supposed to help in decreasing the operation time, thus decreasing the devascularization time to the bone graft. Thus, it helps for increased accuracy to increase three-dimensional bone gain and decrease morbidity of donor site while gaining the maximum available bone volume. Tooth-supported graft placement guide provides reproducible and convenient design without the need of high surgical skills as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tooth-supported Patient-specific Surgical Guide | Experimental | Procedure: 3D ridge augmentation using tooth-supported patient-specific guideIn this study computer-designed patient-specific surgical osteotomy guide provides accurate harvesting of autogenous bone blocks from chin area.Then, graft placement will be done using patient-specific tooth-supported guide in upper anterior deficient ridge and fixation using 2 micro screws labially and one through and through for the palatal shell. |
| Free hand technique | Active comparator | Procedure: 3D ridge augmentation using tooth-supported patient-specific guideThe cortical bone harvested from chin area without surgical guide, then the non-guided mono-cortical bone block grafting will be fixed on the ridge labially using 2 micro screws and one through and through for the palatal shell. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Anterior maxilla with horizontal deficient alveolar ridge that is from 2 to 4 mm measured from the crest of the alveolar ridge buccolingually, combined with vertical deficiency.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| 3D ridge augmentation using tooth-supported patient-specific guideIn this study computer-designed patient-specific surgical osteotomy guide should provide accurate harvesting of autogenous bone blocks from chin area.Then, graft placement will be done using patient-specific tooth-supported guide in upper anterior deficient ridge and fixation using 2 micro screws labially and one through and through for the palatal shell. | Procedure or surgery | Free hand technique, Tooth-supported Patient-specific Surgical Guide |
Primary outcome
Alveolar ridge width bone gain
Time frame: 4 months
measures will be obtained from CT scan in millimetres
1 secondary outcome
Alveolar ridge vertical bone gain
Time frame: 4 months
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 26 Jan 2026.
- Background: PubMed 35218647Aloy-Prosper A, Carramolino-Cuellar E, Penarrocha-Oltra D, Soto-Penaloza D, Penarrocha-Diago M. Intraoral onlay block bone grafts versus cortical tenting technique on alveolar ridge augmentations: a systematic review. Med Oral Patol Oral Cir Bucal. 2022 Mar 1;27(2):e181-e190. doi: 10.4317/medoral.25169.
- Background: PubMed 32045687Cansiz E, Haq J, Manisali M, Cakarer S, Gultekin BA. Long-term evaluation of three-dimensional volumetric changes of augmented severely atrophic maxilla by anterior iliac crest bone grafting. J Stomatol Oral Maxillofac Surg. 2020 Dec;121(6):665-671. doi: 10.1016/j.jormas.2019.11.004. Epub 2020 Feb 8.
- Background: PubMed 19885450Chen ST, Beagle J, Jensen SS, Chiapasco M, Darby I. Consensus statements and recommended clinical procedures regarding surgical techniques. Int J Oral Maxillofac Implants. 2009;24 Suppl:272-8. No abstract available.
- Background: PubMed 27977816De Stavola L, Fincato A, Bressan E, Gobbato L. Results of Computer-Guided Bone Block Harvesting from the Mandible: A Case Series. Int J Periodontics Restorative Dent. 2017 Jan/Feb;37(1):e111-e119. doi: 10.11607/prd.2721.
- Background: PubMed 34682757Naishlos S, Zenziper E, Zelikman H, Nissan J, Mizrahi S, Chaushu G, Matalon S, Chaushu L. Esthetic Assessment Succeeding Anterior Atrophic Maxilla Augmentation with Cancellous Bone-Block Allograft and Late Restoration Loading. J Clin Med. 2021 Oct 9;10(20):4635. doi: 10.3390/jcm10204635.
- 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.
Wesam Sami, Bachelor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D ridge augmentation using tooth-supported patient-specific guide in people with Alveolar Bone Loss, run by Cairo University 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 10 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 26 Jan 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?
Alveolar ridge width 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 NCT07365852, which also lists 5 linked publications.
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 26 Jan 2026.