Horizontal Ridge DeficiencyNCT07056920
Evaluation of Horizontal Bone Gain of Ridge Augmentation Using Customized Porous Zirconia Shell.
A study testing Zirconia shell technique in people with Horizontal Ridge Deficiency and Deficient Alveolar Bone, run by Ahmed Shawky at 1 site in Egypt.
Trial summary
Khoury technique, which employs autogenous bone blocks harvested from the patient, has been widely used for horizontal and vertical ridge augmentation. This method introduces critical limitations, including the technical complexity, morbidity associated with donor site harvesting, such as infection, neurosensory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Horizontal Ridge Deficiency, Deficient Alveolar Bone
- What is being tested?
- Zirconia shell technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2025to 1 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 years old.
- Deficient lower posterior area (Seibert class I).
- Enough inter-arch space for placement of implant-supported prosthesis.
- Motivated the patient to have the treatment.
- Good oral hygiene.
Who cannot join
- Patient with systematic conditions that could interfere with healing process.
- Pregnant females
- Smokers.
- Poor oral hygiene.
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
October University for modern sciences and arts (MSA University)
Giza, Giza Governorate, 12451
Ahmed R. Abdel Elrahman, Professor, 00201206960001, arrahman@msa.edu.eg
Nada Zazou, Lecturer, 00201224016945, nzazou@msa.edu.eg
About this study
Official title: Tomographic Evaluation of The Dimensional Changes After Horizontal Ridge Augmentation of the Lower Posterior Mandible Using a Novel Customized Porous Zirconia Shell Technique: Clinical Case Study.
Khoury technique, which employs autogenous bone blocks harvested from the patient, has been widely used for horizontal and vertical ridge augmentation. This method introduces critical limitations, including the technical complexity, morbidity associated with donor site harvesting, such as infection, neurosensory disturbances, and post-operative discomfort
This clinical case series aims to demonstrate how customized pours zirconium shell could be an alternative technique for ridge augmentation to overcome the limitations of Khoury shell technique.
Read the detailed description
Ridge augmentation is a surgical procedure designed to increase the height and width of the alveolar ridge to provide adequate bone volume for the placement of dental implants. Deficient alveolar ridges are treated using various surgical techniques to restore adequate bone volume for dental implant placement. These techniques include guided bone regeneration (GBR), ridge splitting, distraction osteogenesis, autogenous block bone grafting, onlay bone grafting, and maxillary sinus lifting.
The Khoury technique is a widely recognized approach in dental implantology for horizontal and vertical ridge augmentation. This technique involves the use of autogenous bone blocks harvested from the patient, typically from the mandibular symphysis or ramus. These bone blocks are split into thin laminae and stabilized with micro screws to reconstruct deficient alveolar ridges , and the voids created between the bone blocks are filled with autogenous bone chips to promote regeneration .
This approach is associated with risks, such as donor site morbidity, infection, and potential neurosensory disturbances, sever post operative pain, also technical complexity of the procedure also restricts its application to highly skilled clinicians and patients with adequate donor sites.
These challenges highlight the need for alternative techniques or improved strategies to overcome the limitations of the Khoury technique while achieving predictable outcomes in ridge augmentation procedures.
Zirconia is utilized in the fabrication of zirconia crowns and dental implants, among other dental replacement components. This material is a polycrystalline ceramic with high strength and rigidity, even at small thickness, and bio inertness, among other interesting properties.
The structural integrity of zirconium membranes makes them an excellent choice as non-resorbable membrane for GBR. Studies have demonstrated their excellent biocompatibility, optimal tissue integration, high mechanical strength that ensured effective space maintenance for bone formation, smooth surface that minimized soft tissue ingrowth. Additionally, zirconia's customizable nature allows for precise defect contouring, leading to improved aesthetic outcomes. Overall, zirconia membranes present a valuable tool in GBR procedures, offering potential advantages over traditional materials like titanium meshes .
All those studies used the zirconia as an occlusive 3D non-resorbable membrane except on animal study evaluated the effect of the porous zirconia membrane in comparison to the occlusive one .
In an attempt to overcome the limitation of Khoury technique, zirconia can be used as a shell to augment the deficient alveolar ridges. Hence the purpose of this clinical case series is to introduce a novel customized pours zirconium shell and to tomographically assess the bone gain after horizontal ridge augmentation for deficient mandibular ridges.
- Being tested
- Zirconia shell technique
- Keywords
- ridge augmentation, horizontal ridge augmentation, deficient alveolar ridge, zirconia, non resorbable membrane, khoury technique, zirconia membrane, lingual flap advancement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia shell techniqueProcedure or surgery
Customized Zirconia membrane will be printed as a porous shell and will be used as a non resorbable membrane for horizontal ridge augmentation of deficient posterior mandibular region.
| Study group | Role | What they receive |
|---|---|---|
| Zirconia membrane | Experimental | Customized Zirconia membrane will be used as a non resorbable membrane for horizontal ridge augmentation of deficient posterior mandibular region. Receives: Procedure: Zirconia shell technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal bone gain
Tomographic evaluation of the horizontal bone gain using CBCT in millimeters , CBCT scans will be performed to assess the amount of bone gain in comparison to the preoperative CBCT scans
Measured: 6 months postoperatively.
Secondary outcomes (3)
Soft tissue dehiscence
Any Zirconia membrane exposure at the incision line during the healing period will be considered as soft tissue dehiscence. It will evaluated by:
- Clinical inspection: Yes or No
- any oft tissue dehiscence will be classified according to Fontana Classification (Fontana et al 2011) as:
- Class I: Small membrane exposure (≤ 3 mm) without purulent exudate.
- Class II: Large membrane exposure (> 3 mm) without purulent exudate.
- Class III: Membrane exposure with purulent exudate.
- Class IV: Abscess formation without membrane exposure.
Measured: Soft tissue will be evaluated post-operatively at 1, 2, 4, 6, 8, 12, and 16 week recall appointments
Swelling score
Any Swelling at the surgical area will be evaluated using the Visual Analog Scale (VAS) (0 = no swelling, 4 = extensive swelling) for 1 week postoperatively.
The participants will be instructed to record the presence of the swelling and its degree in swelling chart as follow:
- No swelling
- Slight (Intraoral swelling at surgical site that cannot be recognized by others)
- Moderate (Intraoral swelling at surgical site that can be recognized by others)
- Extensive (Extra-oral swelling that extends beyond surgical site)
Measured: Swelling score will be evaluated for one week postoperatively
Pain score
Pain intensity will be evaluated using the Numerical Rating Scale (NRS) (0 = no pain, 10 = worst pain imaginable). Patients will record the pain score in the pain chart that will be collected at week 1 recall appointment.
Measured: First thing in the morning for the first 7 days post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start15 Mar 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horizontal Ridge DeficiencyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Shawky
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Shawky, October University for Modern Sciences and Arts
- Investigators
- Ahmed R Abd Elrahman, Professor, Study director, Modern Science and Arts UniversityNada Zazou, Lecturer, Study chair, Modern Science and Arts UniversityAhmed S Refaey, Bachelor, Principal investigator, Modern Science and Arts UniversityRasha Attia, Lecturer, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056920
- Sponsor's protocol ID
- PER 4.4.1
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study results will be shared via publication in dental journal.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tomographic Evaluation of The Dimensional Changes After Horizontal Ridge Augmentation of the Lower Posterior Mandible Using a Novel Customized Porous Zirconia Shell Technique: Clinical Case Study.
- ClinicalTrials.gov ID
- NCT07056920
- Acronym / sponsor ID
- PER 4.4.1
- Keywords
- ridge augmentation, horizontal ridge augmentation, deficient alveolar ridge, zirconia, non resorbable membrane, khoury technique, zirconia membrane, lingual flap advancement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ahmed ShawkyUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 9 Jul 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.
Khoury technique, which employs autogenous bone blocks harvested from the patient, has been widely used for horizontal and vertical ridge augmentation. This method introduces critical limitations, including the technical complexity, morbidity associated with donor site harvesting, such as infection, neurosensory disturbances, and post-operative discomfort
This clinical case series aims to demonstrate how customized pours zirconium shell could be an alternative technique for ridge augmentation to overcome the limitations of Khoury shell technique.
Detailed description
Ridge augmentation is a surgical procedure designed to increase the height and width of the alveolar ridge to provide adequate bone volume for the placement of dental implants. Deficient alveolar ridges are treated using various surgical techniques to restore adequate bone volume for dental implant placement. These techniques include guided bone regeneration (GBR), ridge splitting, distraction osteogenesis, autogenous block bone grafting, onlay bone grafting, and maxillary sinus lifting.
The Khoury technique is a widely recognized approach in dental implantology for horizontal and vertical ridge augmentation. This technique involves the use of autogenous bone blocks harvested from the patient, typically from the mandibular symphysis or ramus. These bone blocks are split into thin laminae and stabilized with micro screws to reconstruct deficient alveolar ridges , and the voids created between the bone blocks are filled with autogenous bone chips to promote regeneration .
This approach is associated with risks, such as donor site morbidity, infection, and potential neurosensory disturbances, sever post operative pain, also technical complexity of the procedure also restricts its application to highly skilled clinicians and patients with adequate donor sites.
These challenges highlight the need for alternative techniques or improved strategies to overcome the limitations of the Khoury technique while achieving predictable outcomes in ridge augmentation procedures.
Zirconia is utilized in the fabrication of zirconia crowns and dental implants, among other dental replacement components. This material is a polycrystalline ceramic with high strength and rigidity, even at small thickness, and bio inertness, among other interesting properties.
The structural integrity of zirconium membranes makes them an excellent choice as non-resorbable membrane for GBR. Studies have demonstrated their excellent biocompatibility, optimal tissue integration, high mechanical strength that ensured effective space maintenance for bone formation, smooth surface that minimized soft tissue ingrowth. Additionally, zirconia's customizable nature allows for precise defect contouring, leading to improved aesthetic outcomes. Overall, zirconia membranes present a valuable tool in GBR procedures, offering potential advantages over traditional materials like titanium meshes .
All those studies used the zirconia as an occlusive 3D non-resorbable membrane except on animal study evaluated the effect of the porous zirconia membrane in comparison to the occlusive one .
In an attempt to overcome the limitation of Khoury technique, zirconia can be used as a shell to augment the deficient alveolar ridges. Hence the purpose of this clinical case series is to introduce a novel customized pours zirconium shell and to tomographically assess the bone gain after horizontal ridge augmentation for deficient mandibular ridges.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zirconia membrane | Experimental | Procedure: Zirconia shell techniqueCustomized Zirconia membrane will be used as a non resorbable membrane for horizontal ridge augmentation of deficient posterior mandibular region. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age more than 18 years old.
- Deficient lower posterior area (Seibert class I).
- Enough inter-arch space for placement of implant-supported prosthesis.
- Motivated the patient to have the treatment.
- Good oral hygiene.
Key exclusion criteria (4 listed)
- Patient with systematic conditions that could interfere with healing process.
- Pregnant females
- Smokers.
- Poor oral hygiene.
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 |
|---|---|---|
| Zirconia shell techniqueCustomized Zirconia membrane will be printed as a porous shell and will be used as a non resorbable membrane for horizontal ridge augmentation of deficient posterior mandibular region. | Procedure or surgery | Zirconia membrane |
Primary outcome
Horizontal bone gain
Time frame: 6 months postoperatively.
Tomographic evaluation of the horizontal bone gain using CBCT in millimeters , CBCT scans will be performed to assess the amount of bone gain in comparison to the preoperative CBCT scans
3 secondary outcomes
Soft tissue dehiscence
Time frame: Soft tissue will be evaluated post-operatively at 1, 2, 4, 6, 8, 12, and 16 week recall appointments
Swelling score
Time frame: Swelling score will be evaluated for one week postoperatively
Pain score
Time frame: First thing in the morning for the first 7 days post-operatively.
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 31 Jul 2025.
- Individual participant dataSharing planned: Undecided. Study results will be shared via publication in dental journal.
Related trials for Horizontal Ridge Deficiency
Not yet recruiting
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Shell Technique for Implant Site Development
Ridge Augmentation, Ridge Deficiency
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
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.
Ahmed R Abd Elrahman, Professor study director
Modern Science and Arts University
Nada Zazou, Lecturer study chair
Modern Science and Arts University
Ahmed S Refaey, Bachelor principal investigator
Modern Science and Arts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zirconia shell technique in people with Horizontal Ridge Deficiency and Deficient Alveolar Bone, run by Ahmed Shawky 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 4 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 31 Jul 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?
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 Ahmed S Refaey, Bachelor (+201111989751, Ahmed.shawky2@msa.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 (time frame: 6 months postoperatively.). 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 31 Jul 2025.