Anterior Maxilla Alveolar Bone Deficiency(RCT)NCT07664098
Conventional Flap Versus Vestibular Flap in Bone Augmentation
A study testing vestibular shifted flap for bone augmentation and conventional flap in people with Anterior Maxilla Alveolar Bone Deficiency, run by Cairo University at 1 site in Egypt.
Trial summary
two groups of patients both have alveolar bone deficiency in anterior maxilla, one group will be subjected to khoury bone augmentation with conventional flap the other with vestibular shifted flap Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Maxilla Alveolar Bone Deficiency
- What is being tested?
- vestibular shifted flap for bone augmentation and conventional flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2026to 15 Jun 2027
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients with horizontal bone defects in anterior maxilla
- Mixed dentition age (21-75)
- Good periodontal health
- Non smokers
- Both genders males and females will be included
Who cannot join
- Uncontrolled systemic disease
- General contraindications to surgery.
- Patients participating in other studies, if the present protocol could not be properly followed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
faculty of oral and dental medicine ,Cairo university
Cairo, Giza Governorate, 12613
CEBD@dentistry.cu.edu.eg
About this study
Official title: Assessment of Vestibular Shifted Flap Versus Conventional Flap on Ridge Augmentation in Patients With Anterior Maxillary Bony Deficiency: a Randomized Control Trial
two groups of patients both have alveolar bone deficiency in anterior maxilla, one group will be subjected to khoury bone augmentation with conventional flap the other with vestibular shifted flap
Read the detailed description
The procedure begins with preoperative preparation, including patient positioning in a semi supine position with appropriate head support, induction of local anesthesia, and meticulous surgical site sterilization.
- Full thickness Vestibular flap and 2 horizontal releasing incision are made (Key Concept: The vestibular shifted flap provides additional flap length by translating vestibular mucosa coronally while preserving keratinized tissue and blood supply) in a group and conventional flap in the other group
- Flap elevation: Full thickness flap in the Donor site
- Using piezoelectric device, thin cortical bone blocks (1-1.5 mm thick) are harvested.
- Blocks are carefully shaped into flat "plates."
- The shell Graft placed, adapted and fixed with microscrews to restore desired horizontal dimension
- The space between the host bone and the fixed cortical plates is filled with bone particles.
- Tension free bilayered suturing
- Being tested
- vestibular shifted flap for bone augmentation, conventional flap
- Keywords
- bone deficiency, khoury bone augmentation, anterior maxilla, vestibular shifted flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular shifted flap for bone augmentationProcedure or surgery
The procedure begins with preoperative preparation, including patient positioning in a semi supine position with appropriate head support, induction of local anesthesia, and meticulous surgical site sterilization.
- Full thickness Vestibular flap and 2 horizontal releasing incision are made (Key Concept: The vestibular shifted flap provides additional flap length by translating vestibular mucosa coronally while preserving keratinized tissue and blood supply)
- Flap elevation: Full thickness flap in the Donor site
- Using piezoelectric device, thin cortical bone blocks (1-1.5 mm thick) are harvested.
- Blocks are carefully shaped into flat "plates."
- The shell Graft placed, adapted and fixed with microscrews to restore desired horizontal dimension . • The space between the host bone and the fixed cortical plates is filled with bone particles.
- Tension free bilayered suturing.
conventional flapProcedure or surgery
The procedure begins with preoperative preparation, including patient positioning in a semi supine position with appropriate head support, induction of local anesthesia, and meticulous surgical site sterilization.
- Full thickness conventional flap and 2 horizontal releasing incision are made
- Flap elevation Full thickness flap in the Donor site
- Using piezoelectric device, thin cortical bone blocks (1-1.5 mm thick) are harvested.
- Blocks are carefully shaped into flat "plates."
- The shell Graft placed, adapted and fixed with microscrews to restore desired horizontal dimension.
- The space between the host bone and the fixed cortical plates is filled with bone particles.
- Tension free bilayered suturing
| Study group | Role | What they receive |
|---|---|---|
| vestibular flap group | Experimental | Not described Receives: Procedure: vestibular shifted flap for bone augmentation |
| conventional flap group | Active comparator | Not described Receives: Procedure: conventional flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal Bone Gain Assessed in millimeters by Cone-Beam Computed Tomography (CBCT)
Horizontal bone gain will be evaluated using cone-beam computed tomography (CBCT). Alveolar ridge width will be measured in millimeters (mm) at standardized reference points before the augmentation procedure and at 6 months postoperatively. The outcome will be calculated as the change in ridge width (mm) from baseline to follow-up.
Measured: 6 months
Secondary outcomes (1)
Width of Keratinized Tissue Assessed by Periodontal Probe
The width of keratinized tissue will be measured clinically using a calibrated periodontal probe and recorded in millimeters (mm) at baseline and 6 months postoperatively. The outcome will be calculated as the change in keratinized tissue width from baseline to follow-up.
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 posted23 Jun 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Maxilla Alveolar Bone DeficiencyStudies 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
- Model description
- Parallel Assignment Randomized clinical trial A trial will be carried out in hospital of Oral and Maxilofacial surgery department- Faculty of Oral and Dental Medicine Cairo University. Equal randomization: participants with equal probabilities for intervention Positive controlled :Both groups receiving treatment Parallel group study: Each group of patients receives a single treatment simultaneously.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piatrece Amgad Wadeea, Cairo University
- Investigators
- Sameh mekhemer, PHD, Study director, Mekhemer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664098
- Sponsor's protocol ID
- vestibular & conventional flap
- Acronym
- (RCT)
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vestibular Shifted Flap Versus Conventional Flap on Ridge Augmentation in Patients With Anterior Maxillary Bony Deficiency: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07664098
- Acronym / sponsor ID
- (RCT) / vestibular & conventional flap
- Keywords
- bone deficiency, khoury bone augmentation, anterior maxilla, vestibular shifted flap
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 23 Jun 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.
two groups of patients both have alveolar bone deficiency in anterior maxilla, one group will be subjected to khoury bone augmentation with conventional flap the other with vestibular shifted flap
Detailed description
The procedure begins with preoperative preparation, including patient positioning in a semi supine position with appropriate head support, induction of local anesthesia, and meticulous surgical site sterilization.
- Full thickness Vestibular flap and 2 horizontal releasing incision are made (Key Concept: The vestibular shifted flap provides additional flap length by translating vestibular mucosa coronally while preserving keratinized tissue and blood supply) in a group and conventional flap in the other group
- Flap elevation: Full thickness flap in the Donor site
- Using piezoelectric device, thin cortical bone blocks (1-1.5 mm thick) are harvested.
- Blocks are carefully shaped into flat "plates."
- The shell Graft placed, adapted and fixed with microscrews to restore desired horizontal dimension
- The space between the host bone and the fixed cortical plates is filled with bone particles.
- Tension free bilayered suturing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment Randomized clinical trial A trial will be carried out in hospital of Oral and Maxilofacial surgery department- Faculty of Oral and Dental Medicine Cairo University. Equal randomization: participants with equal probabilities for intervention Positive controlled :Both groups receiving treatment Parallel group study: Each group of patients receives a single treatment simultaneously.
| Arm | Type | Receives |
|---|---|---|
| vestibular flap group | Experimental | Procedure: vestibular shifted flap for bone augmentation |
| conventional flap group | Active comparator | Procedure: conventional flap |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients with horizontal bone defects in anterior maxilla
- Mixed dentition age (21-75)
- Good periodontal health
- Non smokers
- Both genders males and females will be included
Key exclusion criteria (3 listed)
- Uncontrolled systemic disease
- General contraindications to surgery.
- Patients participating in other studies, if the present protocol could not be properly followed.
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 |
|---|---|---|
| vestibular shifted flap for bone augmentationThe procedure begins with preoperative preparation, including patient positioning in a semi supine position with appropriate head support, induction of local anesthesia, and meticulous surgical site sterilization. * Full thickness Vestibular flap and 2 horizontal releasing incision are made (Key Concept: The vestibular shifted flap provides additional flap length by translating vestibular mucosa coronally while preserving keratinized tissue and blood supply) * Flap elevation: Full thickness flap in the Donor site * Using piezoelectric device, thin cortical bone blocks (1-1.5 mm thick) are harvested. * Blocks are carefully shaped into flat "plates." * The shell Graft placed, adapted and fixed with microscrews to restore desired horizontal dimension . • The space between the host bone and the fixed cortical plates is filled with bone particles. * Tension free bilayered suturing. | Procedure or surgery | vestibular flap group |
| conventional flapThe procedure begins with preoperative preparation, including patient positioning in a semi supine position with appropriate head support, induction of local anesthesia, and meticulous surgical site sterilization. * Full thickness conventional flap and 2 horizontal releasing incision are made * Flap elevation Full thickness flap in the Donor site * Using piezoelectric device, thin cortical bone blocks (1-1.5 mm thick) are harvested. * Blocks are carefully shaped into flat "plates." * The shell Graft placed, adapted and fixed with microscrews to restore desired horizontal dimension. * The space between the host bone and the fixed cortical plates is filled with bone particles. * Tension free bilayered suturing | Procedure or surgery | conventional flap group |
Primary outcome
Horizontal Bone Gain Assessed in millimeters by Cone-Beam Computed Tomography (CBCT)
Time frame: 6 months
Horizontal bone gain will be evaluated using cone-beam computed tomography (CBCT). Alveolar ridge width will be measured in millimeters (mm) at standardized reference points before the augmentation procedure and at 6 months postoperatively. The outcome will be calculated as the change in ridge width (mm) from baseline to follow-up.
1 secondary outcome
Width of Keratinized Tissue Assessed by Periodontal Probe
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 23 Jun 2026.
- Khoury, F., \& Hanser, T. (2015). Three-dimensional horizontal alveolar ridge augmentation in the posterior maxilla: Evaluation of 10-year results. International Journal of Oral \& Maxillofacial Implants, 30(1), 169-178Link provided by the sponsor.
- Salem, A. S., Abdel-Rahman, F. H., Shaker, A. E., El-Farag, S. A., \& El-Kenawy, M. H. (2024). Comparison of khoury\\'s bone shell technique vs titanium-reinforced polytetrafluoroethylene membrane for 3D-bone augmentation in atrophic posterior mandible: ALink provided by the sponsor.
- Ayman, D., Shawky, M., Aly, L. A., Mounir, M., \& Zekry, A. K. (2025). Bone gain and Accuracy Assessment of computer-guided workflow for horizontal augmentation of atrophic anterior maxilla with symphyseal cortical plates: A randomized controlled trial. BLink provided by the sponsor.
- Awad, K. A., Tawik, M. A.-M., Hussein, M. M., El-Farag, S. A., \& Sameaa, S. E. (2025). Tooth shell versus bone shell technique for horizontal maxillary alveolar ridge augmentation. BMC Oral Health, 25(1).Link provided by the sponsor.
- Iglesias Velázquez, Ó., Tresguerres, F. G. F., Leco Berrocal, I., Tresguerres, I. F., LópezPintor, R. M., Carballido, J., López-Quiles, J., \& Torres, J. (2021). Split bone block technique: 4-month results of a randomised clinical trial comparing clinicaLink provided by the sponsor.
- Verardi, S., \& Simion, M. (2007). Management of the exposure of e-PTFE membranes in guided bone regeneration. Practical Procedures \& Aesthetic Dentistry.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Anterior Maxilla Alveolar Bone Deficiency
Active, not recruitingObservational study
Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
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.
Sameh mekhemer, PHD study director
Mekhemer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vestibular shifted flap for bone augmentation and conventional flap in people with Anterior Maxilla Alveolar Bone Deficiency, 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 5 inclusion and 3 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 23 Jun 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?
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 Piatrece Amgad Wadeea, BSc (01288293090, piatrece.wadeea@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal Bone Gain Assessed in millimeters by Cone-Beam Computed Tomography (CBCT) (time frame: 6 months). 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 23 Jun 2026.