Deficient Alveolar BoneNCT07040124
Assessment of Efficacy of Prebent Titanium Mesh Versus Customized Poly-ether Ether Ketone Mesh for Three Dimensional Augmentation in Deficient Maxillary Ridge. a Randomized Controlled Clinical Trial.
A study testing ti mesh and 3d peek mesh in people with Deficient Alveolar Bone, run by Basma Alsheikh at 1 site in Egypt.
Trial summary
In conclusion, the choice between titanium and PEEK meshes should consider patient-specific factors, clinical requirements, and surgeon expertise. The PEEK mesh, with its patient customized design enabled by CAD/CAM technology, offers significant advantages, including greater gained bone volume and reduced operative… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Deficient Alveolar Bone
- What is being tested?
- ti mesh and 3d peek mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Feb 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Adult patient of both sexes presenting with partially edentulous maxillary ridge with horizontal bone defect. 2. The horizontal ridge dimension measured 2mm below the alveolar crest should range from 2-5 mm. 3. No local pathosis that may interfere with bone healing. 4. Good oral hygiene. 5. Age between 20-65 years old.
Who cannot join
- Patient taking any medication that may interfere with normal bone physiology or impair bone healing. 2. All patients suffering from any systemic disease that may affect bone healing. 3. Heavy smokers (more than 10 cigarette per day) 4. Patients with parafunctional habits such as bruxism and clenching 5. Poor interest and cooperation from the patient. 6. Patients that have undergone any horizontal augmentation procedure at the site of interest
Trial locations and contacts
1 site in 1 country.
About this study
In conclusion, the choice between titanium and PEEK meshes should consider patient-specific factors, clinical requirements, and surgeon expertise. The PEEK mesh, with its patient customized design enabled by CAD/CAM technology, offers significant advantages, including greater gained bone volume and reduced operative time. Its tailored fabrication ensures precise adaptation to the patient's anatomy, effectively maintaining the space required for optimal bone formation. The integration of such advanced technologies in regenerative procedures represents a significant step forward in achieving predictable outcomes and enhancing patient care. However, continued innovation and evaluation are crucial to refine these approaches and expand their applicability in oral rehabilitation
- Conditions
- Deficient Alveolar Bone
- Being tested
- ti mesh, 3d peek mesh
- Keywords
- augmentation,, peek, titanium mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ti meshProcedure or surgery
prebent titamesh on a 3-d virtually augmented model
3d peek meshProcedure or surgery
milled 3d peek mesh
| Study group | Role | What they receive |
|---|---|---|
| prebent titanium mesh | Active comparator | participants receive alveolar ridge augmentation using pre-bent titanium mesh Receives: Procedure: ti mesh |
| 3d peek mesh | Active comparator | participants receive maxillary ridge augmentation using 3d milled peek mesh Receives: Procedure: 3d peek mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
horizontal bone gain
cbct analysis for bone gain
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 posted27 Jun 2025
- Study start1 Oct 2020
- Primary completion1 Jan 2025
- Study completion1 Feb 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 Deficient Alveolar BoneStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basma Alsheikh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Basma Alsheikh, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040124
- Sponsor's protocol ID
- 1125486
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alshikh BAA, Eid MH, Amin A, Elsholkamy M. Assessment of two treatment protocols using prebent titanium mesh and customized PEEK mesh for predominantly horizontal maxillary ridge augmentation with volumetric evaluation: a randomized clinical trial. BMC Oral Health. 2026 Jun 16;26(1):1056. doi: 10.1186/s12903-026-08720-w.
PubMed 42298522
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy of Prebent Titanium Mesh Versus Customized Poly-ether Ether Ketone Mesh for Three Dimensional Augmentation in Deficient Maxillary Ridge. a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07040124
- Acronym / sponsor ID
- 1125486
- Conditions
- Deficient Alveolar Bone
- Keywords
- augmentation,, peek, titanium mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Basma AlsheikhUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 27 Jun 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.
In conclusion, the choice between titanium and PEEK meshes should consider patient-specific factors, clinical requirements, and surgeon expertise. The PEEK mesh, with its patient customized design enabled by CAD/CAM technology, offers significant advantages, including greater gained bone volume and reduced operative time. Its tailored fabrication ensures precise adaptation to the patient's anatomy, effectively maintaining the space required for optimal bone formation. The integration of such advanced technologies in regenerative procedures represents a significant step forward in achieving predictable outcomes and enhancing patient care. However, continued innovation and evaluation are crucial to refine these approaches and expand their applicability in oral rehabilitation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prebent titanium mesh | Active comparator | Procedure: ti meshparticipants receive alveolar ridge augmentation using pre-bent titanium mesh |
| 3d peek mesh | Active comparator | Procedure: 3d peek meshparticipants receive maxillary ridge augmentation using 3d milled peek mesh |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Adult patient of both sexes presenting with partially edentulous maxillary ridge with horizontal bone defect. 2. The horizontal ridge dimension measured 2mm below the alveolar crest should range from 2-5 mm. 3. No local pathosis that may interfere with bone healing. 4. Good oral hygiene. 5. Age between 20-65 years old.
Key exclusion criteria (1 listed)
- Patient taking any medication that may interfere with normal bone physiology or impair bone healing. 2. All patients suffering from any systemic disease that may affect bone healing. 3. Heavy smokers (more than 10 cigarette per day) 4. Patients with parafunctional habits such as bruxism and clenching 5. Poor interest and cooperation from the patient. 6. Patients that have undergone any horizontal augmentation procedure at the site of interest
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 |
|---|---|---|
| ti meshprebent titamesh on a 3-d virtually augmented model | Procedure or surgery | prebent titanium mesh |
| 3d peek meshmilled 3d peek mesh | Procedure or surgery | 3d peek mesh |
Primary outcome
horizontal bone gain
Time frame: 6 months
cbct analysis for bone gain
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 27 Jun 2025.
- Derived from this study: PubMed 42298522Alshikh BAA, Eid MH, Amin A, Elsholkamy M. Assessment of two treatment protocols using prebent titanium mesh and customized PEEK mesh for predominantly horizontal maxillary ridge augmentation with volumetric evaluation: a randomized clinical trial. BMC Oral Health. 2026 Jun 16;26(1):1056. doi: 10.1186/s12903-026-08720-w.
- 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.
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 ti mesh and 3d peek mesh in people with Deficient Alveolar Bone, run by Basma Alsheikh 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 1 inclusion and 1 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 27 Jun 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?
horizontal bone gain (time frame: 6 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 NCT07040124, 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 27 Jun 2025.