Maxillary Augmentation in Horizontal Bone DefectRCTNCT07210385
Radiographic and Histomorphometric Assessment of Anterior Horizontal Maxillary Bone Augmentation Using Autogenous and Bovine Sticky Bone Versus Autogenous and Bovine Bone Shell Technique (Khoury): A Randomized Comparative Clinical Trial
A study testing anterior horizontal maxillary bone augmentation using autogenous and bovine sticky bone and anterior horizontal maxillary bone augmentation using autogenous and bovine bone shell technique (khoury) in people with Maxillary Augmentation in Horizontal Bone Defect, run by Cairo University at 1 site in Egypt.
Trial summary
This clinical trial aims to compare two bone augmentation techniques for patients with anterior horizontal maxillary bone defects: Autogenous and Bovine Sticky Bone Technique using S1 Bovine Bone Graft Autogenous and Bovine Bone Shell Technique (Khoury Technique). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Maxillary Augmentation in Horizontal Bone Defect
- What is being tested?
- anterior horizontal maxillary bone augmentation using autogenous and bovine sticky bone and anterior horizontal maxillary bone augmentation using autogenous and bovine bone shell technique (khoury)
- 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
- 30 Jul 2025to 28 Feb 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-55 years.
- Both males and females.
- Patients with horizontal bone deficiency in the anterior maxillary region (< 3 mm width) requiring augmentation prior to implant placement.
- Adequate oral hygiene and commitment to follow-up visits.
Who cannot join
- Patients with systemic diseases affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
- Heavy smokers (>10 cigarettes/day).
- Pregnant or lactating women.
- Previous bone grafting procedures at the same site.
- Patients on medications affecting bone metabolism (e.g., bisphosphonates).
Trial locations and contacts
1 site in 1 country.
About this study
This clinical trial aims to compare two bone augmentation techniques for patients with anterior horizontal maxillary bone defects:
Autogenous and Bovine Sticky Bone Technique using S1 Bovine Bone Graft Autogenous and Bovine Bone Shell Technique (Khoury Technique). The study will evaluate the amount of bone gain and the quality of bone formation after six months using radiographic (CBCT) and histomorphometric analysis. Patients will be randomly assigned to one of the two groups and followed for six months post-surgery to assess bone regeneration, surgical outcomes, and potential complications.
Read the detailed description
This randomized controlled clinical trial will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Cairo University. The study addresses the clinical challenge of horizontal maxillary bone defects, which complicate implant placement and require effective augmentation techniques.
Two techniques will be compared:
Autogenous and Bovine Sticky Bone: Using S1 Bovine Bone Graft mixed with autogenous bone chips in a 70:30 ratio.
Autogenous and Bovine Bone Shell Technique (Khoury): Using autogenous cortical bone shells harvested from the mandible combined with S1 Bovine Bone.
The primary outcome is horizontal bone gain assessed by CBCT immediately after surgery and at six months before implant placement. Secondary outcomes include histomorphometric analysis of bone core biopsies to evaluate the quality of bone regeneration.
Randomization will be performed with a 1:1 allocation ratio using computer-generated sequences. Patients will be blinded to the intervention, and follow-up will be conducted at 3 days, 1 week, 1 month, 2 months, and 6 months postoperatively.
The trial aims to determine whether the less invasive sticky bone technique can achieve comparable or superior bone regeneration outcomes compared to the traditional bone shell method while reducing donor site morbidity and surgical complexity
- Being tested
- anterior horizontal maxillary bone augmentation using autogenous and bovine sticky bone, anterior horizontal maxillary bone augmentation using autogenous and bovine bone shell technique (khoury)
- Keywords
- Horizontal Bone Defects , Maxillary augmentation , sticky bone , bone shell technique , dental implants, alveolar ridge augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior horizontal maxillary bone augmentation using autogenous and bovine sticky boneProcedure or surgery
Participants in this group will undergo maxillary horizontal ridge augmentation using a mixture of autogenous bone chips and S1 Bovine Bone Graft in a 70:30 ratio. The graft will be prepared as Sticky Bone and applied to the defect site for augmentation.
anterior horizontal maxillary bone augmentation using autogenous and bovine bone shell technique (khoury)Procedure or surgery
Participants in this group will undergo maxillary horizontal ridge augmentation using the Khoury Bone Shell Technique, combining autogenous bone blocks and Bovine Bone Graft to reconstruct the alveolar ridge. The graft will be fixed and stabilized to provide a rigid shell for bone regeneration.
| Study group | Role | What they receive |
|---|---|---|
| Autogenous + Bovine Sticky Bone | Experimental | Participants in this group will undergo maxillary horizontal ridge augmentation using a mixture of autogenous bone chips and S1 Bovine Bone Graft in a 70:30 ratio, prepared as Sticky Bone in the area of the defect Receives: Procedure: anterior horizontal maxillary bone augmentation using autogenous and bovine sticky bone |
| Autogenous + Bovine Bone Shell Technique (Khoury) | Active comparator | Participants in this group will undergo horizontal ridge augmentation using autogenous cortical bone plates harvested from the mandibular ramus fixed to the recipient site, with S1 Bovine Bone Graft used to fill the gap between plates and the alveolar bone. Receives: Procedure: anterior horizontal maxillary bone augmentation using autogenous and bovine bone shell technique (khoury) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Horizontal Maxillary Alveolar ridge bone gain
The primary outcome measure will be the amount of horizontal bone gain at the augmented site measured in millimeters using Cone Beam Computed Tomography (CBCT). Measurements will be taken immediately after augmentation and at 6 months before implant placement.
Measured: Baseline (immediately post-surgery) 6 months after augmentation
Secondary outcomes (1)
Quality of bone formation
Bone core biopsy will be obtained at the time of implant placement to assess the percentage of newly formed bone, residual graft material, and connective tissue using histomorphometric analysis.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start30 Jul 2025
- Primary completion28 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
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 Maxillary Augmentation in Horizontal Bone DefectStudies 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
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Mohammed Ahmed Ahmed Salama, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210385
- Sponsor's protocol ID
- omfs 3-3-20
- Other IDs
- self funded
- Acronym
- RCT
- Status last verified
- Jul 2025
- First submitted
- 30 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data (IPD) has not yet been made. Data sharing will depend on institutional review board (IRB) approvals, institutional policies, and participant consent. If data sharing is approved in the future, detailed information about the process, access conditions, and timelines will be provided.
Publications
Shaker AE, Salem AS, El-Farag SA, Abdel-Rahman FH, El-Kenawy MH. Comparison of Khoury's Bone Shell Technique vs Titanium-reinforced Polytetrafluoroethylene Membrane for 3D-bone Augmentation in Atrophic Posterior Mandible: A Randomized Clinical Trial. J Contemp Dent Pract. 2024 Jun 1;25(6):518-526. doi: 10.5005/jp-journals-10024-3704.
PubMed 39364817Tony JB, Parthasarathy H, Tadepalli A, Ponnaiyan D, Alamoudi A, Kamil MA, Alzahrani KJ, Alsharif KF, Halawani IF, Alnfiai MM, Ramachandran L, Balaji TM, Patil S. CBCT Evaluation of Sticky Bone in Horizontal Ridge Augmentation with and without Collagen Membrane-A Randomized Parallel Arm Clinical Trial. J Funct Biomater. 2022 Oct 19;13(4):194. doi: 10.3390/jfb13040194.
PubMed 36278663Yazhini P K, Suresh N, Kaarthikeyan G. Subperiosteal Ridge Augmentation Technique Utilizing Sticky Bone: A Case Series. Cureus. 2024 Jul 29;16(7):e65641. doi: 10.7759/cureus.65641. eCollection 2024 Jul.
PubMed 39205712Barbu HM, Iancu SA, Rapani A, Stacchi C. Guided Bone Regeneration with Concentrated Growth Factor Enriched Bone Graft Matrix (Sticky Bone) vs. Bone-Shell Technique in Horizontal Ridge Augmentation: A Retrospective Study. J Clin Med. 2021 Aug 31;10(17):3953. doi: 10.3390/jcm10173953.
PubMed 34501399De Angelis P, Cavalcanti C, Manicone PF, Liguori MG, Rella E, De Rosa G, Palmieri A, D'Addona A. A Comparison of Guided Bone Regeneration vs. the Shell Technique Using Xenogeneic Bone Blocks in Horizontal Bone Defects: A Randomized Clinical Trial. Dent J (Basel). 2024 May 9;12(5):137. doi: 10.3390/dj12050137.
PubMed 38786535
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic and Histomorphometric Assessment of Anterior Horizontal Maxillary Bone Augmentation Using Autogenous and Bovine Sticky Bone Versus Autogenous and Bovine Bone Shell Technique (Khoury): A Randomized Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT07210385
- Acronym / sponsor ID
- RCT / omfs 3-3-20
- Keywords
- Horizontal Bone Defects , Maxillary augmentation , sticky bone , bone shell technique , dental implants, alveolar ridge augmentation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 28 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 7 Oct 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.
This clinical trial aims to compare two bone augmentation techniques for patients with anterior horizontal maxillary bone defects:
Autogenous and Bovine Sticky Bone Technique using S1 Bovine Bone Graft Autogenous and Bovine Bone Shell Technique (Khoury Technique). The study will evaluate the amount of bone gain and the quality of bone formation after six months using radiographic (CBCT) and histomorphometric analysis. Patients will be randomly assigned to one of the two groups and followed for six months post-surgery to assess bone regeneration, surgical outcomes, and potential complications.
Detailed description
This randomized controlled clinical trial will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Cairo University. The study addresses the clinical challenge of horizontal maxillary bone defects, which complicate implant placement and require effective augmentation techniques.
Two techniques will be compared:
Autogenous and Bovine Sticky Bone: Using S1 Bovine Bone Graft mixed with autogenous bone chips in a 70:30 ratio.
Autogenous and Bovine Bone Shell Technique (Khoury): Using autogenous cortical bone shells harvested from the mandible combined with S1 Bovine Bone.
The primary outcome is horizontal bone gain assessed by CBCT immediately after surgery and at six months before implant placement. Secondary outcomes include histomorphometric analysis of bone core biopsies to evaluate the quality of bone regeneration.
Randomization will be performed with a 1:1 allocation ratio using computer-generated sequences. Patients will be blinded to the intervention, and follow-up will be conducted at 3 days, 1 week, 1 month, 2 months, and 6 months postoperatively.
The trial aims to determine whether the less invasive sticky bone technique can achieve comparable or superior bone regeneration outcomes compared to the traditional bone shell method while reducing donor site morbidity and surgical complexity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autogenous + Bovine Sticky Bone | Experimental | Procedure: anterior horizontal maxillary bone augmentation using autogenous and bovine sticky boneParticipants in this group will undergo maxillary horizontal ridge augmentation using a mixture of autogenous bone chips and S1 Bovine Bone Graft in a 70:30 ratio, prepared as Sticky Bone in the area of the defect |
| Autogenous + Bovine Bone Shell Technique (Khoury) | Active comparator | Procedure: anterior horizontal maxillary bone augmentation using autogenous and bovine bone shell technique (khoury)Participants in this group will undergo horizontal ridge augmentation using autogenous cortical bone plates harvested from the mandibular ramus fixed to the recipient site, with S1 Bovine Bone Graft used to fill the gap between plates and the alveolar bone. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 18-55 years.
- Both males and females.
- Patients with horizontal bone deficiency in the anterior maxillary region (< 3 mm width) requiring augmentation prior to implant placement.
- Adequate oral hygiene and commitment to follow-up visits.
Key exclusion criteria (5 listed)
- Patients with systemic diseases affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
- Heavy smokers (>10 cigarettes/day).
- Pregnant or lactating women.
- Previous bone grafting procedures at the same site.
- Patients on medications affecting bone metabolism (e.g., bisphosphonates).
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 |
|---|---|---|
| anterior horizontal maxillary bone augmentation using autogenous and bovine sticky boneParticipants in this group will undergo maxillary horizontal ridge augmentation using a mixture of autogenous bone chips and S1 Bovine Bone Graft in a 70:30 ratio. The graft will be prepared as Sticky Bone and applied to the defect site for augmentation. | Procedure or surgery | Autogenous + Bovine Sticky Bone |
| anterior horizontal maxillary bone augmentation using autogenous and bovine bone shell technique (khoury)Participants in this group will undergo maxillary horizontal ridge augmentation using the Khoury Bone Shell Technique, combining autogenous bone blocks and Bovine Bone Graft to reconstruct the alveolar ridge. The graft will be fixed and stabilized to provide a rigid shell for bone regeneration. | Procedure or surgery | Autogenous + Bovine Bone Shell Technique (Khoury) |
Primary outcome
Anterior Horizontal Maxillary Alveolar ridge bone gain
Time frame: Baseline (immediately post-surgery) 6 months after augmentation
The primary outcome measure will be the amount of horizontal bone gain at the augmented site measured in millimeters using Cone Beam Computed Tomography (CBCT). Measurements will be taken immediately after augmentation and at 6 months before implant placement.
1 secondary outcome
Quality of bone formation
Time frame: Up to 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 7 Oct 2025.
- Background: PubMed 39364817Shaker AE, Salem AS, El-Farag SA, Abdel-Rahman FH, El-Kenawy MH. Comparison of Khoury's Bone Shell Technique vs Titanium-reinforced Polytetrafluoroethylene Membrane for 3D-bone Augmentation in Atrophic Posterior Mandible: A Randomized Clinical Trial. J Contemp Dent Pract. 2024 Jun 1;25(6):518-526. doi: 10.5005/jp-journals-10024-3704.
- Background: PubMed 36278663Tony JB, Parthasarathy H, Tadepalli A, Ponnaiyan D, Alamoudi A, Kamil MA, Alzahrani KJ, Alsharif KF, Halawani IF, Alnfiai MM, Ramachandran L, Balaji TM, Patil S. CBCT Evaluation of Sticky Bone in Horizontal Ridge Augmentation with and without Collagen Membrane-A Randomized Parallel Arm Clinical Trial. J Funct Biomater. 2022 Oct 19;13(4):194. doi: 10.3390/jfb13040194.
- Background: PubMed 39205712Yazhini P K, Suresh N, Kaarthikeyan G. Subperiosteal Ridge Augmentation Technique Utilizing Sticky Bone: A Case Series. Cureus. 2024 Jul 29;16(7):e65641. doi: 10.7759/cureus.65641. eCollection 2024 Jul.
- Background: PubMed 34501399Barbu HM, Iancu SA, Rapani A, Stacchi C. Guided Bone Regeneration with Concentrated Growth Factor Enriched Bone Graft Matrix (Sticky Bone) vs. Bone-Shell Technique in Horizontal Ridge Augmentation: A Retrospective Study. J Clin Med. 2021 Aug 31;10(17):3953. doi: 10.3390/jcm10173953.
- Background: PubMed 38786535De Angelis P, Cavalcanti C, Manicone PF, Liguori MG, Rella E, De Rosa G, Palmieri A, D'Addona A. A Comparison of Guided Bone Regeneration vs. the Shell Technique Using Xenogeneic Bone Blocks in Horizontal Bone Defects: A Randomized Clinical Trial. Dent J (Basel). 2024 May 9;12(5):137. doi: 10.3390/dj12050137.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data (IPD) has not yet been made. Data sharing will depend on institutional review board (IRB) approvals, institutional policies, and participant consent. If data sharing is approved in the future, detailed information about the process, access conditions, and timelines will be provided.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anterior horizontal maxillary bone augmentation using autogenous and bovine sticky bone and anterior horizontal maxillary bone augmentation using autogenous and bovine bone shell technique (khoury) in people with Maxillary Augmentation in Horizontal Bone Defect, 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 5 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2025. 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?
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?
Anterior Horizontal Maxillary Alveolar ridge bone gain (time frame: Baseline (immediately post-surgery) 6 months after augmentation). 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 NCT07210385, 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 7 Oct 2025.