Alveolar Bone LossNCT07669792
Khoury's Bone Shell Technique Versus Titanium-Reinforced Polytetrafluoroethylene for Augmentation of Horizontal Deficiency in Posterior Mandible (Histomorphometry Analysis)
A study testing GBR using Ti based PTFE and Bone Shell Khoury's Technique in people with Alveolar Bone Loss and Posterior Mandible, run by British University In Egypt at 1 site in Egypt.
Trial summary
The purpose of the study is the comparison of bone gained histologically from the Bone Shell Khoury's Technique in comparison with the usage of non-resorbable membrane polytetrafluoroethylene and discussing its eligibility for implant placement in restoring the atrophic posterior mandible. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss, Posterior Mandible
- What is being tested?
- GBR using Ti based PTFE and Bone Shell Khoury's Technique
- 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
- 20 Jun 2025to Mar 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have two or more missing teeth in the posterior mandibular segment.
- The patients age of 18 and above.
- The alveolar ridge in the edentulous site of the selected patients will have a buccolingual width of less than 4mm.
- Sufficient vertical bone height.
- Free of any local or systemic condition that may contraindicate ridge expansion procedure.
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.
- Smokers.
- Patient's that have been diagnosed with periodontal disease, as sufficient ridge height would be improbable.
- Patients with significant vitamin D deficiency.
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, 1 recruiting
- Recruiting
The British University in Egypt
Cairo
Oral and Maxillofacial Lecturer, +201005609359, Moataz.Bahaa@bue.edu.eg
About this study
Official title: Khoury's Bone Shell Technique Versus Titanium-Reinforced Polytetrafluoroethylene for Augmentation of Horizontal Deficiency in Posterior Mandible (Histomorphometry Analysis): A Randomized Clinical Trial
The purpose of the study is the comparison of bone gained histologically from the Bone Shell Khoury's Technique in comparison with the usage of non-resorbable membrane polytetrafluoroethylene and discussing its eligibility for implant placement in restoring the atrophic posterior mandible.
Read the detailed description
The aim of this study is to assess the bone gained histologically when comparing the following different techniques:
One of the techniques that is used for bone augmentation is the Khoury technique which entails that a split cortical bone shell obtained from the ramus area through piezoelectric surgery. The thin laminae of bone obtained is stabilized in the defect area labially through micro screws and the generated gap is filled through a mixture of autogenous that could be obtained from the retromolar area through special burs as the auto chip maker (ACM) or via bone scrapper. The obtained is mixed with an equal ratio with xenograft or bone obtained from animal source to fill the created gap.
Another technique involves the usage of a non-resorbable membrane known as reinforced titanium PTFE that is stabilized from both the lingual and labial aspects via micro screws .It's then filled with a mixture of both autogenous and xenograft for maximizing the bone formation capability. In some cases, the reinforced titanium PTFE is covered with collagen membrane to avoid one of the common drawbacks of this technique which is wound dehiscence.
This study aims to evaluate the bone quality gained from both techniques.
- Conditions
- Alveolar Bone Loss, Posterior Mandible
- Being tested
- GBR using Ti based PTFE, Bone Shell Khoury's Technique
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBR using Ti based PTFEProcedure or surgery
Patients will receive a non resorbable membrane using titanium reinforced polytetrafluorethylene membrane with full releasing flap buccal and lingual with the lingual dissection for the releasing of the mylohyoid attachment and nerve dissection of the mental nerve buccally. The membrane needs to be fixed lingually with microscrews or titanium screws then the gap will be filled through Auto Chip Maker ACM or bone scraper from the external oblique ridge. Then the harvested bone shall be mixed xenograft with ratio 70 to 30 then the membrane fixed buccally as well as covered by collagen membrane to avoid one of the main obstacles of the procedure which is wound dehiscence.
Bone Shell Khoury's TechniqueProcedure or surgery
A block graft using Khoury Technique: Prior to harvesting the needed bone, measurement of the defect size as well as measurement of the donor site bone block will be harvested from the mandibular retromolar area. The bone shall be acquired through piezoelectric device that perform the osteotomy then separated through the usage of thin chisel. The acquired bone needs to be smoothened to avoid any sharp edge that may cause wound dehiscence or infection. The harvested bone will be divided into two thinner bone shells through using titanium disk with copious irrigation with saline. The bone shell shall be fixated in the defect site buccally through two microscrews at least then the created space shall be filled with a combination of autogenous bones harvested through Auto Chip Maker (ACM) or bone scraper from the external oblique ridge. The harvested bone will be combined with xenograft with ratio 70 to 30 then the defect shall be covered with collagen membrane.
| Study group | Role | What they receive |
|---|---|---|
| GBR using Ti based PTFE | Experimental | This group will receive a non resorbable membrane using titanium reinforced polytetrafluorethylene membrane. Receives: Procedure: GBR using Ti based PTFE |
| Bone Shell Khoury's Technique | Active comparator | This group will receive a block graft using Khoury Technique. Receives: Procedure: Bone Shell Khoury's Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histomorphometric analysis of gained bone
Primary evaluation is achieved through re opening of the flap after 6 months for removing the microscrews used in Khoury group and the nonresorbable membrane as well as the screws will be removed from the nonresorbable membrane group. Then the usage of 2 millimeters bur for core biopsy at the site of the implant that will be placed.
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 posted25 Jun 2026
- Study start20 Jun 2025
- Primary completionOct 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelaziz, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669792
- Sponsor's protocol ID
- 25-018
- Status last verified
- Jul 2026
- First submitted
- 21 Jun 2026
- Last updated
- 16 Jul 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Khoury's Bone Shell Technique Versus Titanium-Reinforced Polytetrafluoroethylene for Augmentation of Horizontal Deficiency in Posterior Mandible (Histomorphometry Analysis): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07669792
- Acronym / sponsor ID
- 25-018
- Conditions
- Alveolar Bone Loss, Posterior Mandible
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 25 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.
The purpose of the study is the comparison of bone gained histologically from the Bone Shell Khoury's Technique in comparison with the usage of non-resorbable membrane polytetrafluoroethylene and discussing its eligibility for implant placement in restoring the atrophic posterior mandible.
Detailed description
The aim of this study is to assess the bone gained histologically when comparing the following different techniques:
One of the techniques that is used for bone augmentation is the Khoury technique which entails that a split cortical bone shell obtained from the ramus area through piezoelectric surgery. The thin laminae of bone obtained is stabilized in the defect area labially through micro screws and the generated gap is filled through a mixture of autogenous that could be obtained from the retromolar area through special burs as the auto chip maker (ACM) or via bone scrapper. The obtained is mixed with an equal ratio with xenograft or bone obtained from animal source to fill the created gap.
Another technique involves the usage of a non-resorbable membrane known as reinforced titanium PTFE that is stabilized from both the lingual and labial aspects via micro screws .It's then filled with a mixture of both autogenous and xenograft for maximizing the bone formation capability. In some cases, the reinforced titanium PTFE is covered with collagen membrane to avoid one of the common drawbacks of this technique which is wound dehiscence.
This study aims to evaluate the bone quality gained from both techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GBR using Ti based PTFE | Experimental | Procedure: GBR using Ti based PTFEThis group will receive a non resorbable membrane using titanium reinforced polytetrafluorethylene membrane. |
| Bone Shell Khoury's Technique | Active comparator | Procedure: Bone Shell Khoury's TechniqueThis group will receive a block graft using Khoury Technique. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have two or more missing teeth in the posterior mandibular segment.
- The patients age of 18 and above.
- The alveolar ridge in the edentulous site of the selected patients will have a buccolingual width of less than 4mm.
- Sufficient vertical bone height.
- Free of any local or systemic condition that may contraindicate ridge expansion procedure.
Key exclusion criteria (6 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.
- Smokers.
- 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 |
|---|---|---|
| GBR using Ti based PTFEPatients will receive a non resorbable membrane using titanium reinforced polytetrafluorethylene membrane with full releasing flap buccal and lingual with the lingual dissection for the releasing of the mylohyoid attachment and nerve dissection of the mental nerve buccally. The membrane needs to be fixed lingually with microscrews or titanium screws then the gap will be filled through Auto Chip Maker ACM or bone scraper from the external oblique ridge. Then the harvested bone shall be mixed xenograft with ratio 70 to 30 then the membrane fixed buccally as well as covered by collagen membrane to avoid one of the main obstacles of the procedure which is wound dehiscence. | Procedure or surgery | GBR using Ti based PTFE |
| Bone Shell Khoury's TechniqueA block graft using Khoury Technique: Prior to harvesting the needed bone, measurement of the defect size as well as measurement of the donor site bone block will be harvested from the mandibular retromolar area. The bone shall be acquired through piezoelectric device that perform the osteotomy then separated through the usage of thin chisel. The acquired bone needs to be smoothened to avoid any sharp edge that may cause wound dehiscence or infection. The harvested bone will be divided into two thinner bone shells through using titanium disk with copious irrigation with saline. The bone shell shall be fixated in the defect site buccally through two microscrews at least then the created space shall be filled with a combination of autogenous bones harvested through Auto Chip Maker (ACM) or bone scraper from the external oblique ridge. The harvested bone will be combined with xenograft with ratio 70 to 30 then the defect shall be covered with collagen membrane. | Procedure or surgery | Bone Shell Khoury's Technique |
Primary outcome
Histomorphometric analysis of gained bone
Time frame: 6 Months
Primary evaluation is achieved through re opening of the flap after 6 months for removing the microscrews used in Khoury group and the nonresorbable membrane as well as the screws will be removed from the nonresorbable membrane group. Then the usage of 2 millimeters bur for core biopsy at the site of the implant that will be placed.
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 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Alveolar Bone Loss
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GBR using Ti based PTFE and Bone Shell Khoury's Technique in people with Alveolar Bone Loss and Posterior Mandible, 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 Jul 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 Abdelaziz H. Saad Abdelkarim, Bachelor's Degree (+201020690459, PG.Abdelaziz92344012@bue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histomorphometric analysis of gained bone (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 16 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.