Maxillary Alveolar ReconstructionNCT07103577
Guided Island Osteoperiosteal Flap Versus Ridge Splitting for Anterior Atrophic Maxillary
A study testing Island osteoperiosteal flap and Conventional ridge splitting in people with Maxillary Alveolar Reconstruction and Virtual Surgical Planning, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Background: After tooth extraction changes of the shape of the alveolar bone follows a predictable pattern, which proves to be challenging in restoring its form and function, especially in the esthetic zone. Autogenous grafts remain the gold standard because of their predictability. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Maxillary Alveolar Reconstruction, Virtual Surgical Planning
- What is being tested?
- Island osteoperiosteal flap and Conventional ridge splitting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Nov 2023to 13 May 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient seeking replacement of a missed maxillary anterior tooth by a delayed dental implant procedure.
- Residual bone height is (8-15) mm and (3-4) mm alveolar bone width.
- Good oral hygiene.
Who cannot join
- Uncontrolled Diabetes.
- Coagulation disorders.
- Immunological disorders.
- Previous radiation of the head and neck region.
- Abnormal bone physiology.
- Therapy with Bisphosphonates.
- Heavy smokers.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: Guided Island Osteoperiosteal Flap Versus Ridge Splitting for Anterior Atrophic Maxillary Augmentation With Implant Placement (a Randomized Controlled Clinical Trial)
Background: After tooth extraction changes of the shape of the alveolar bone follows a predictable pattern, which proves to be challenging in restoring its form and function, especially in the esthetic zone. Autogenous grafts remain the gold standard because of their predictability. The island osteoperiosteal flap (I-flap) is introduced as a modified alveolar split bone grafting technique used to gain width, height and modify the facial or buccal bone plate position.
Aim of the study: This study aims to evaluate in anterior atrophic maxillary ridge augmentation using guided unreflected island osteoperiosteal flap (I-Flap) approach with simultaneous implant placement and interpostional bone grafting in comparison to computer guided ridge splitting method.
- Being tested
- Island osteoperiosteal flap, Conventional ridge splitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Island osteoperiosteal flapProcedure or surgery
Crestal incision using no. 15 blade on a bard parker no. 3. Two blind lateral vertical ostotomies at about 1.5 to 2 mm from the adjacent tooth roots to preserve subpapillary and root bone coverage. These cuts are to ensure the complete fracture of buccal plate while being attached to the overlying periosteum.
Conventional ridge splittingProcedure or surgery
Crestal incision and 2 vertical releasing incisions will be made using a no.15 blade mounted on a Bard Parker no.3. Then, a full mucoperiosteal flap reflection to expose bone.
| Study group | Role | What they receive |
|---|---|---|
| Computer guided island flap | Experimental | Not described Receives: Procedure: Island osteoperiosteal flap |
| Computer guided conventional ridge splitting | Active comparator | Not described Receives: Procedure: Conventional ridge splitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores
Pain (by Visual Analogous Scale):
Score 0 - No pain. Scores 1 to 3 - Mild pain. Scores 3 to 7 - Moderate pain. scores 7 to 10 - severe pain.
Measured: 1 day, 3rd day and 1 week
Secondary implant stability
implant stability was measured using ostell device
Measured: 4 months
Change in bone level (bone gain)
Immediate post-operative CBCT (T1) will be done to measure the alveolar bone gain, to assess the proper implant positioning, and finally to measure the width of the out-fractured buccal plate and the amount of interpositional bone graft.
Four months postoperatively CBCT (T2) will be done to measure amount of bone gain
Measured: Baseline and 4 months
Change in bone density
Bone density at implant body is measured by using computerized tomography values
Measured: baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start5 Nov 2023
- Primary completion13 May 2025
- Study completion13 May 2025
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 Maxillary Alveolar ReconstructionStudies 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103577
- Sponsor's protocol ID
- 0840-01/2024
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salem OAEH, Elmahlawy AS, Saber ME. Evaluation of 3-Dimensional accuracy of guided implant placement using guided osteoperiosteal flap versus guided ridge splitting for atrophic maxillary augmentation (a randomized clinical trial). BMC Oral Health. 2025 Dec 5;25(1):1905. doi: 10.1186/s12903-025-07364-6.
PubMed 41350657
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Island Osteoperiosteal Flap Versus Ridge Splitting for Anterior Atrophic Maxillary Augmentation With Implant Placement (a Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07103577
- Acronym / sponsor ID
- 0840-01/2024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 5 Aug 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.
Background: After tooth extraction changes of the shape of the alveolar bone follows a predictable pattern, which proves to be challenging in restoring its form and function, especially in the esthetic zone. Autogenous grafts remain the gold standard because of their predictability. The island osteoperiosteal flap (I-flap) is introduced as a modified alveolar split bone grafting technique used to gain width, height and modify the facial or buccal bone plate position.
Aim of the study: This study aims to evaluate in anterior atrophic maxillary ridge augmentation using guided unreflected island osteoperiosteal flap (I-Flap) approach with simultaneous implant placement and interpostional bone grafting in comparison to computer guided ridge splitting method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer guided island flap | Experimental | Procedure: Island osteoperiosteal flap |
| Computer guided conventional ridge splitting | Active comparator | Procedure: Conventional ridge splitting |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient seeking replacement of a missed maxillary anterior tooth by a delayed dental implant procedure.
- Residual bone height is (8-15) mm and (3-4) mm alveolar bone width.
- Good oral hygiene.
Key exclusion criteria (7 listed)
- Uncontrolled Diabetes.
- Coagulation disorders.
- Immunological disorders.
- Previous radiation of the head and neck region.
- Abnormal bone physiology.
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 |
|---|---|---|
| Island osteoperiosteal flapCrestal incision using no. 15 blade on a bard parker no. 3. Two blind lateral vertical ostotomies at about 1.5 to 2 mm from the adjacent tooth roots to preserve subpapillary and root bone coverage. These cuts are to ensure the complete fracture of buccal plate while being attached to the overlying periosteum. | Procedure or surgery | Computer guided island flap |
| Conventional ridge splittingCrestal incision and 2 vertical releasing incisions will be made using a no.15 blade mounted on a Bard Parker no.3. Then, a full mucoperiosteal flap reflection to expose bone. | Procedure or surgery | Computer guided conventional ridge splitting |
Primary outcome
Change in pain scores
Time frame: 1 day, 3rd day and 1 week
Pain (by Visual Analogous Scale): Score 0 - No pain. Scores 1 to 3 - Mild pain. Scores 3 to 7 - Moderate pain. scores 7 to 10 - severe pain.
Secondary implant stability
Time frame: 4 months
implant stability was measured using ostell device
Change in bone level (bone gain)
Time frame: Baseline and 4 months
Immediate post-operative CBCT (T1) will be done to measure the alveolar bone gain, to assess the proper implant positioning, and finally to measure the width of the out-fractured buccal plate and the amount of interpositional bone graft. Four months postoperatively CBCT (T2) will be done to measure amount of bone gain
Change in bone density
Time frame: baseline and 4 months
Bone density at implant body is measured by using computerized tomography values
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 5 Aug 2025.
- Derived from this study: PubMed 41350657Salem OAEH, Elmahlawy AS, Saber ME. Evaluation of 3-Dimensional accuracy of guided implant placement using guided osteoperiosteal flap versus guided ridge splitting for atrophic maxillary augmentation (a randomized clinical trial). BMC Oral Health. 2025 Dec 5;25(1):1905. doi: 10.1186/s12903-025-07364-6.
- Individual participant dataSharing planned: No
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 Island osteoperiosteal flap and Conventional ridge splitting in people with Maxillary Alveolar Reconstruction and Virtual Surgical Planning, run by Hams Hamed Abdelrahman 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 7 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 5 Aug 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?
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?
Change in pain scores (time frame: 1 day, 3rd day and 1 week). The study lists 4 primary outcomes in all. 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 NCT07103577, 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 5 Aug 2025.