Alveolar Bone LossNCT07841158
Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation Using Customized Porous Zirconia Shell
A study testing Customized porous zirconia shell in people with Alveolar Bone Loss and Alveolar Ridge Deficiency, run by Mohammed Mahmoud Abed at 1 site in Egypt.
Trial summary
The goal of this clinical study is to learn whether a custom-made porous zirconia shell can support good-quality new bone when widening the lower back jaw before dental implant placement. The study includes adults whose jawbone in this area is too narrow for implants (Seibert Class I defects). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alveolar Bone Loss, Alveolar Ridge Deficiency
- What is being tested?
- Customized porous zirconia shell
- Type of treatment
- Medical device
- 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 Jul 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 21 years old
- Horizontal bone loss in the lower posterior area (Seibert Class I)
- Enough inter-arch space for placement of implant-supported prosthesis
- Motivated patient to have the treatment
- Good oral hygiene
Who cannot join
- Patients with systemic conditions that could interfere with the 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), Faculty of Dentistry
Giza, Giza Governorate
Mohammed Mahmoud Abed, BDS, 00201118322238, mohammed.mahmoud12@msa.edu.eg
Ahmed Reda Abd Elrahman, PhD, 00201206960001, arrahman@msa.edu.eg
About this study
Official title: Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation of the Lower Posterior Mandible Using a Novel Customized Porous Zirconia Shell Technique: Clinical Case Study
The goal of this clinical study is to learn whether a custom-made porous zirconia shell can support good-quality new bone when widening the lower back jaw before dental implant placement. The study includes adults whose jawbone in this area is too narrow for implants (Seibert Class I defects).
The main question it aims to answer is: What is the quality of the new bone formed under a porous zirconia shell, and how much inflammation does the tissue show?
Read more
Participants will:
- Receive gum treatment and a CBCT scan before surgery
- Have bone augmentation surgery, in which a digitally designed porous zirconia shell is fixed over a mixture of their own bone and xenograft
- Return after 2 weeks for suture removal and a check of the wound
- Return after 6 months for a CBCT scan, removal of the shell, collection of a small bone sample (biopsy), and dental implant placement
Read the detailed description
Horizontal bone loss in the posterior mandible often prevents dental implant placement. The Khoury technique uses thin autogenous cortical bone plates to rebuild the ridge, but harvesting these plates causes donor-site morbidity, is technically demanding, and is limited by available bone. Zirconia is biocompatible, mechanically strong and osteoconductive, and has shown low inflammatory response. However, it has not been studied as a shell replacing autogenous bone plates.
In this single-arm study, 10 adults with Seibert Class I defects in the posterior mandible will first receive non-surgical periodontal therapy. Compliance will be checked after 1 month. A zirconia shell with 1.5 mm pores will be digitally designed from each patient's CBCT scan, milled on a 5-axis machine, then cleaned and sterilized.
Under local anesthesia, buccal and lingual full-thickness flaps will be raised and the recipient bone decorticated. Autogenous bone chips will be harvested from the mandibular body with a bone chip maker and mixed 1:1 with xenograft. The shell will be fixed over the graft with 3-4 buccal screws. The flaps will be advanced and closed with a double-layer suture.
After 6 months, the shell will be removed, a core biopsy will be taken, and an implant will be placed. The biopsies will be fixed in 10% formalin and analyzed histologically, histomorphometrically and for tissue inflammatory response.
- Conditions
- Alveolar Bone Loss, Alveolar Ridge Deficiency
- Being tested
- Customized porous zirconia shell
- Keywords
- Zirconia shell, Horizontal ridge augmentation, Guided bone regeneration, Histomorphometry, Posterior mandible, Dental implants, Histology
- 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.
Customized porous zirconia shellDevice
A CAD/CAM-milled zirconia shell with 1.5 mm pores, designed from each patient's CBCT scan and fixed with 3-4 buccal screws over a 1:1 mix of autogenous bone chips and xenograft. It replaces the autogenous cortical plates used in the Khoury technique and is removed after 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Customized Porous Zirconia Shell | Experimental | Participants with horizontal bone defects in the posterior mandible receive ridge augmentation using a patient-specific porous zirconia shell fixed over a 1:1 mixture of autogenous bone and xenograft. After 6 months, the shell is removed, a bone biopsy is taken, and a dental implant is placed. Receives: Device: Customized porous zirconia shell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Newly Formed Bone Assessed by Descriptive Histological Analysis of the Core Biopsy
Histological analysis of the core bone biopsy harvested from the augmented site. Specimens will be fixed in a 10% formalin solution. Descriptive analysis of the cells and tissue structure of the augmented site within the biopsy (Dellavia et al., 2021).
Measured: 6 months after ridge augmentation (at shell removal and implant placement)
Secondary outcomes (4)
Percentage of Newly Formed Bone (% of Total Biopsy Area)
Histomorphometric measurement of the new bone area as a percentage of the total biopsy area.
Measured: 6 months after augmentation
Percentage of Residual Graft Material (% of Total Biopsy Area)
Histomorphometric measurement of the remaining graft particle area as a percentage of the total biopsy area.
Measured: 6 months after augmentation
Percentage of Soft Tissue (% of Total Biopsy Area)
Histomorphometric measurement of the non-mineralized connective tissue area as a percentage of the total biopsy area.
Measured: 6 months after augmentation
Inflammatory Cell Infiltration Score
Semi-quantitative tissue response score from 0 (no inflammatory cells) to 4 (severe cellular infiltrate or tissue necrosis), based on the presence of lymphocytes, macrophages, foreign body giant cells, eosinophils and neutrophils.
Measured: 6 months after augmentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start15 Mar 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Jul 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed Mahmoud Abed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammed Mahmoud Abed, October University for Modern Sciences and Arts
- Investigators
- Nada Abdelmonem Zazou, PhD, Study director, October University for Modern Sciences and Arts (MSA)Ahmed Reda Abd Elrahman, PhD, Study chair, October University for Modern Sciences and Arts (MSA)Mahmoud Ibrahim Nassar, PhD, Study director, October University for Modern Sciences and Arts (MSA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841158
- Sponsor's protocol ID
- REC-D 6206-5
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient confidentiality, as stated in the approved protocol. Study results will be published in a peer-reviewed dental journal.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation of the Lower Posterior Mandible Using a Novel Customized Porous Zirconia Shell Technique: Clinical Case Study
- ClinicalTrials.gov ID
- NCT07841158
- Acronym / sponsor ID
- REC-D 6206-5
- Conditions
- Alveolar Bone Loss, Alveolar Ridge Deficiency
- Keywords
- Zirconia shell, Horizontal ridge augmentation, Guided bone regeneration, Histomorphometry, Posterior mandible, Dental implants, Histology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mohammed Mahmoud AbedUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 25 Sep 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 goal of this clinical study is to learn whether a custom-made porous zirconia shell can support good-quality new bone when widening the lower back jaw before dental implant placement. The study includes adults whose jawbone in this area is too narrow for implants (Seibert Class I defects).
The main question it aims to answer is: What is the quality of the new bone formed under a porous zirconia shell, and how much inflammation does the tissue show?
Participants will:
- Receive gum treatment and a CBCT scan before surgery
- Have bone augmentation surgery, in which a digitally designed porous zirconia shell is fixed over a mixture of their own bone and xenograft
- Return after 2 weeks for suture removal and a check of the wound
- Return after 6 months for a CBCT scan, removal of the shell, collection of a small bone sample (biopsy), and dental implant placement
Detailed description
Horizontal bone loss in the posterior mandible often prevents dental implant placement. The Khoury technique uses thin autogenous cortical bone plates to rebuild the ridge, but harvesting these plates causes donor-site morbidity, is technically demanding, and is limited by available bone. Zirconia is biocompatible, mechanically strong and osteoconductive, and has shown low inflammatory response. However, it has not been studied as a shell replacing autogenous bone plates.
In this single-arm study, 10 adults with Seibert Class I defects in the posterior mandible will first receive non-surgical periodontal therapy. Compliance will be checked after 1 month. A zirconia shell with 1.5 mm pores will be digitally designed from each patient's CBCT scan, milled on a 5-axis machine, then cleaned and sterilized.
Under local anesthesia, buccal and lingual full-thickness flaps will be raised and the recipient bone decorticated. Autogenous bone chips will be harvested from the mandibular body with a bone chip maker and mixed 1:1 with xenograft. The shell will be fixed over the graft with 3-4 buccal screws. The flaps will be advanced and closed with a double-layer suture.
After 6 months, the shell will be removed, a core biopsy will be taken, and an implant will be placed. The biopsies will be fixed in 10% formalin and analyzed histologically, histomorphometrically and for tissue inflammatory response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Customized Porous Zirconia Shell | Experimental | Device: Customized porous zirconia shellParticipants with horizontal bone defects in the posterior mandible receive ridge augmentation using a patient-specific porous zirconia shell fixed over a 1:1 mixture of autogenous bone and xenograft. After 6 months, the shell is removed, a bone biopsy is taken, and a dental implant is placed. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age more than 21 years old
- Horizontal bone loss in the lower posterior area (Seibert Class I)
- Enough inter-arch space for placement of implant-supported prosthesis
- Motivated patient to have the treatment
- Good oral hygiene
Key exclusion criteria (4 listed)
- Patients with systemic conditions that could interfere with the 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 |
|---|---|---|
| Customized porous zirconia shellA CAD/CAM-milled zirconia shell with 1.5 mm pores, designed from each patient's CBCT scan and fixed with 3-4 buccal screws over a 1:1 mix of autogenous bone chips and xenograft. It replaces the autogenous cortical plates used in the Khoury technique and is removed after 6 months. | Device | Customized Porous Zirconia Shell |
Primary outcome
Quality of Newly Formed Bone Assessed by Descriptive Histological Analysis of the Core Biopsy
Time frame: 6 months after ridge augmentation (at shell removal and implant placement)
Histological analysis of the core bone biopsy harvested from the augmented site. Specimens will be fixed in a 10% formalin solution. Descriptive analysis of the cells and tissue structure of the augmented site within the biopsy (Dellavia et al., 2021).
4 secondary outcomes
Percentage of Newly Formed Bone (% of Total Biopsy Area)
Time frame: 6 months after augmentation
Percentage of Residual Graft Material (% of Total Biopsy Area)
Time frame: 6 months after augmentation
Percentage of Soft Tissue (% of Total Biopsy Area)
Time frame: 6 months after augmentation
Inflammatory Cell Infiltration Score
Time frame: 6 months after augmentation
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 30 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient confidentiality, as stated in the approved protocol. Study results will be published in a peer-reviewed dental journal.
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Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
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Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
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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.
Nada Abdelmonem Zazou, PhD study director
October University for Modern Sciences and Arts (MSA)
Ahmed Reda Abd Elrahman, PhD study chair
October University for Modern Sciences and Arts (MSA)
Mahmoud Ibrahim Nassar, PhD study director
October University for Modern Sciences and Arts (MSA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customized porous zirconia shell in people with Alveolar Bone Loss and Alveolar Ridge Deficiency, run by Mohammed Mahmoud Abed 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 30 Sep 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 Mohammed Mahmoud Abed, BDS (00201118322238, mohammed.mahmoud12@msa.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Newly Formed Bone Assessed by Descriptive Histological Analysis of the Core Biopsy (time frame: 6 months after ridge augmentation (at shell removal and implant placement)). 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 30 Sep 2026.