- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07365852
Accuracy Assessment of Chin Graft for Ridge Augmentation Using Tooth-supported Guide Versus Free Hand Technique
January 22, 2026 updated by: Wesam Sami Hassan Ali, Cairo University
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 12311
- Faculty of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
• 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
Exclusion Criteria:
- 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.
- Pregnant or nursing females.
- Immunosuppressed or immunocompromised
- Heavy smokers
- Patients undergo medication interfere with bone healing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tooth-supported Patient-specific Surgical Guide
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.
|
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.
|
|
Active Comparator: Free hand technique
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alveolar ridge width bone gain
Time Frame: 4 months
|
measures will be obtained from CT scan in millimetres
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alveolar ridge vertical bone gain
Time Frame: 4 months
|
measures will be obtained from CT scan in millimetres
|
4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of the Computer-assisted guide in the study group
Time Frame: immediate post-operative
|
measures will be obtained from CT scan in millimetres
|
immediate post-operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wesam Sami, Bachelor, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chen 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.
- 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.
- Cansiz 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.
- De 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.
- Naishlos 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2024
Primary Completion (Actual)
April 1, 2025
Study Completion (Actual)
September 30, 2025
Study Registration Dates
First Submitted
June 25, 2024
First Submitted That Met QC Criteria
January 22, 2026
First Posted (Actual)
January 26, 2026
Study Record Updates
Last Update Posted (Actual)
January 26, 2026
Last Update Submitted That Met QC Criteria
January 22, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4596
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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