Atrophic RidgeNCT07394933
Guided Bone Regeneration Using Ti-Reinforced PTFE Membrane Vs. Khoury's Technique in Augmentation of Posterior Mandibular Defects
A study testing Khoury's bone shell technique and GBR using Ti-reinforced PTFE Membrane in people with Atrophic Ridge, run by British University In Egypt at 1 site in Egypt.
Trial summary
The aim of the present clinical trial is to compare two different alveolar ridge bone augmentation techniques for mandibular horizontal bone defects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrophic Ridge
- What is being tested?
- Khoury's bone shell technique and GBR using Ti-reinforced PTFE Membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2025to Apr 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have one or more missing teeth in the posterior mandibular segment.
- The alveolar ridge in the edentulous site of the selected patients will have a buccolingual width of less than 5 mm.
- Sufficient vertical bone height above inferior alveolar nerve.
- Free of any local or systemic condition that may contraindicate ridge expansion procedure.
- No sex predilection.
- The patient will be between the ages of 18-70 years.
Who cannot join
- Patients taking any medication that may interfere with bone healing or bone biology.
- Patients with any systemic disease that may affect bone healing.
- Any patients with any previous bone grafting procedure at the site of interest.
- Heavy Smokers (more than 20 cigarettes daily).
- Patient's that have been diagnosed with periodontal disease, as sufficient ridge height would be improbable.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present clinical trial is to compare two different alveolar ridge bone augmentation techniques for mandibular horizontal bone defects.
Read the detailed description
Will using PTFE membrane with a mixture of xenograft and particulate autogenous bone result in bone gain similar to standard Khoury's bone shell technique?
- Conditions
- Atrophic Ridge
- Being tested
- Khoury's bone shell technique, GBR using Ti-reinforced PTFE Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Khoury's bone shell techniqueProcedure or surgery
Bone blocks will be harvested from the retromolar area after measuring of the size required and measuring of the donor site anatomy. Piezoelectric device will be used to perform the graft osteotomy. The block size should be slightly larger than the defect size. Sharp bony edges will be smoothened, and the donor defect will be packed with gelatin sponges. The bone block margins will be smoothened and separated into two thinner bone shells using titanium disk with copious saline irrigation. The blocks will be fixed into the recipient site buccally using at least two micro-screws leaving a gap to be filled with bone graft.
GBR using Ti-reinforced PTFE MembraneProcedure or surgery
A non-resorbable ti-enforced polytetrafluoroethylene (PTFE) membrane will be fixed with titanium screws on the lingual bone plate and on the buccal bone plate allowing for packing of particulate mix of bone graft (50% Xenograft: 50% Autogenous graft).
| Study group | Role | What they receive |
|---|---|---|
| Khoury's bone shell technique | Active comparator | Bone blocks will be harvested from the retromolar area after measuring of the size required and measuring of the donor site anatomy. Piezoelectric device will be used to perform the graft osteotomy. The block size should be slightly larger than the defect size. Sharp bony edges will be smoothened, and the donor defect will be packed with gelatin sponges. The bone block margins will be smoothened and separated into two thinner bone shells using titanium disk with copious saline irrigation. The blocks will be fixed into the recipient site buccally using at least two micro-screws leaving a gap to be filled with bone graft. Receives: Procedure: Khoury's bone shell technique |
| GBR using Ti-reinforced PTFE Membrane | Experimental | A non-resorbable ti-enforced polytetrafluoroethylene (PTFE) membrane will be fixed with titanium screws on the lingual bone plate and on the buccal bone plate allowing for packing of particulate mix of bone graft (50% Xenograft: 50% Autogenous graft). Receives: Procedure: GBR using Ti-reinforced PTFE Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cone Beam Volumetric Topography (CBVT)
Measured: 6 Months
Secondary outcomes (1)
Clinical measurement: the frequency of complications
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 posted6 Feb 2026
- Study start15 Jun 2025
- Primary completion15 Oct 2025
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic RidgeStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hassan El-Zaher, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394933
- Sponsor's protocol ID
- 25-019
- Status last verified
- Feb 2026
- First submitted
- 31 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Bone Regeneration Using Ti-Reinforced PTFE Membrane Vs. Khoury's Technique in Augmentation of Posterior Mandibular Defects
- ClinicalTrials.gov ID
- NCT07394933
- Acronym / sponsor ID
- 25-019
- Conditions
- Atrophic Ridge
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- Apr 2026 (estimated)
- First posted
- 6 Feb 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.
The aim of the present clinical trial is to compare two different alveolar ridge bone augmentation techniques for mandibular horizontal bone defects.
Detailed description
Will using PTFE membrane with a mixture of xenograft and particulate autogenous bone result in bone gain similar to standard Khoury's bone shell technique?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Khoury's bone shell technique | Active comparator | Procedure: Khoury's bone shell techniqueBone blocks will be harvested from the retromolar area after measuring of the size required and measuring of the donor site anatomy. Piezoelectric device will be used to perform the graft osteotomy. The block size should be slightly larger than the defect size. Sharp bony edges will be smoothened, and the donor defect will be packed with gelatin sponges. The bone block margins will be smoothened and separated into two thinner bone shells using titanium disk with copious saline irrigation. The blocks will be fixed into the recipient site buccally using at least two micro-screws leaving a gap to be filled with bone graft. |
| GBR using Ti-reinforced PTFE Membrane | Experimental | Procedure: GBR using Ti-reinforced PTFE MembraneA non-resorbable ti-enforced polytetrafluoroethylene (PTFE) membrane will be fixed with titanium screws on the lingual bone plate and on the buccal bone plate allowing for packing of particulate mix of bone graft (50% Xenograft: 50% Autogenous graft). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have one or more missing teeth in the posterior mandibular segment.
- The alveolar ridge in the edentulous site of the selected patients will have a buccolingual width of less than 5 mm.
- Sufficient vertical bone height above inferior alveolar nerve.
- Free of any local or systemic condition that may contraindicate ridge expansion procedure.
- No sex predilection.
Key exclusion criteria (5 listed)
- Patients taking any medication that may interfere with bone healing or bone biology.
- Patients with any systemic disease that may affect bone healing.
- Any patients with any previous bone grafting procedure at the site of interest.
- Heavy Smokers (more than 20 cigarettes daily).
- Patient's that have been diagnosed with periodontal disease, as sufficient ridge height would be improbable.
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 |
|---|---|---|
| Khoury's bone shell techniqueBone blocks will be harvested from the retromolar area after measuring of the size required and measuring of the donor site anatomy. Piezoelectric device will be used to perform the graft osteotomy. The block size should be slightly larger than the defect size. Sharp bony edges will be smoothened, and the donor defect will be packed with gelatin sponges. The bone block margins will be smoothened and separated into two thinner bone shells using titanium disk with copious saline irrigation. The blocks will be fixed into the recipient site buccally using at least two micro-screws leaving a gap to be filled with bone graft. | Procedure or surgery | Khoury's bone shell technique |
| GBR using Ti-reinforced PTFE MembraneA non-resorbable ti-enforced polytetrafluoroethylene (PTFE) membrane will be fixed with titanium screws on the lingual bone plate and on the buccal bone plate allowing for packing of particulate mix of bone graft (50% Xenograft: 50% Autogenous graft). | Procedure or surgery | GBR using Ti-reinforced PTFE Membrane |
Primary outcome
Cone Beam Volumetric Topography (CBVT)
Time frame: 6 Months
1 secondary outcome
Clinical measurement: the frequency of complications
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 18 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Atrophic Ridge
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Comparison Between Neutral Zone and Admixed Impression Techniques for Atrophic Mandibular Ridges
Atrophic Mandibular Ridge in Edentulous Patients
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Not yet recruiting
HydroGraft for Mandibular Horizontal Ridge Atrophy Augmentation.
Alveolar Ridge Atrophy
Recruiting
Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation Using Customized Porous Zirconia Shell
Alveolar Bone Loss, Alveolar Ridge Deficiency
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Autogenous Sticky Bone Plus Platelet-rich Fibrin Membrane Versus Xenograft With Collagen Membrane for Posterior Atrophic Mandible
Ridge Augmentation
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 Khoury's bone shell technique and GBR using Ti-reinforced PTFE Membrane in people with Atrophic Ridge, run by British University In Egypt 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 6 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 18 Feb 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?
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?
Cone Beam Volumetric Topography (CBVT) (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 18 Feb 2026.