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RecruitingNCT07841158Updated Sep 30, 2026

Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation Using Customized Porous Zirconia Shell

An interventional study of Customized porous zirconia shell in Alveolar Bone Loss and Alveolar Ridge Deficiency, sponsored by Mohammed Mahmoud Abed. Recruiting at 1 site in Egypt. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Mohammed Mahmoud Abed · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Mar 2025, registered Sep 2026).
  • Started Mar 2025; still recruiting 1 year 7 months later.
Updated Sep 30, 2026Eligibility revisedPrimary outcomes revised+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 74 studies in Alveolar Bone Loss with a site in Egypt — 22 open to participants now, 26 under way, none of them phase 3. Alveolar Bone Loss · Egypt.

Planned enrollment
64th of 73
10 · median 20
Started
2025
with 13 others
No phase
67 of 74
19 open now
Primary completion
2027-05
later than 23 of 25 live
Registered
72nd of 74
by date

Among the 74 studies in Alveolar Bone Loss with a site in Egypt, this one is the 64th largest by planned enrollment of the 73 interventional ones that give a count, is one of 14 that started in 2025, is one of 67 with no phase, reaches primary completion later than 23 of the 25 other live ones, and was the 72nd registered.

Alveolar Bone Loss

318 studies on the registry are indexed under Alveolar Bone Loss; 79 are open to participants now.

Browse Alveolar Bone Loss studies →

Open to participants now

22 of the 74 studies in Alveolar Bone Loss with a site in Egypt are open now. Recruiting first, the newest first:

16 more — sign in →

All 22 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 47 Alveolar Bone Loss studies recruiting now, 19 (40%) set no upper age limit and 22 (47%) stop at 75 or younger; 4 take children under 18; 24 take healthy volunteers.

This study: 21 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 74 studies in Alveolar Bone Loss with a site in Egypt, or all of them as a file.
02

Study 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).

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
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.

03

Conditions studied

  • Alveolar Bone Loss
  • Alveolar Ridge Deficiency

Browse trials for

Keywords

  • Zirconia shell
  • Horizontal ridge augmentation
  • Guided bone regeneration
  • Histomorphometry
  • Posterior mandible
  • Dental implants
  • Histology
04

Who can participate

The criteria were revised on the registry on Sep 30, 2026. See what changed

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients with systemic conditions that could interfere with the healing process
  • Pregnant females
  • Smokers
  • Poor oral hygiene
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Customized Porous Zirconia Shell

    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.

    Device: Customized porous zirconia shell

Interventions

  • DeviceCustomized porous zirconia shell

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 6 months after ridge augmentation (at shell removal and implant placement)

Secondary outcomes

  1. Percentage of Newly Formed Bone (% of Total Biopsy Area)

    Histomorphometric measurement of the new bone area as a percentage of the total biopsy area.

    Time frame: 6 months after augmentation

  2. 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.

    Time frame: 6 months after augmentation

  3. 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.

    Time frame: 6 months after augmentation

  4. 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.

    Time frame: 6 months after augmentation

07

Study locations

1 of 1 sites recruiting
  • October University for Modern Sciences and Arts (MSA), Faculty of Dentistry
    Giza, Giza Governorate, Egypt
    Recruiting
    • Mohammed Mahmoud Abed, BDS · Contactmohammed.mahmoud12@msa.edu.eg · 00201118322238
    • Ahmed Reda Abd Elrahman, PhD · Contactarrahman@msa.edu.eg · 00201206960001
    • Ahmed Reda Abd Elrahman, PhD · Sub investigator
    • Mohammed Mahmoud Abed, BDS · Principal investigator
    • Nada Abdelmonem Zazou, PhD · Sub investigator
    • Mahmoud Ibrahim Nassar, PhD · Sub investigator
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for May 2027, 25 months after the start.

Of 167 non-industry interventional studies with no phase under Alveolar Bone Loss, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 25 months is above that.

Counting every sponsor, half of 167 studies reached it within 18 months; a quarter within 11 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2026
First posted
Sep 25, 2026
StartActual
Mar 15, 2025
Primary completionEst.
May 1, 2027
CompletionEst.
Jul 1, 2027
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
4 inclusion criteria edited; 1 exclusion criterion edited, 2 added, 2 removed
What changed in the criteria
Inclusion criteria
  • EditedAdults olderAge more than 21 years old
  • EditedHorizontal bone defectloss in the lower posterior area (Seibert Class I) in the posterior mandible
  • EditedEnough inter-arch space for anplacement of implant-supported prosthesis
  • EditedMotivated patient to receivehave the treatment
Exclusion criteria
  • EditedSystemicPatients with systemic conditions that could interfere with the healing process
  • RemovedPregnancy
  • RemovedSmoking
  • AddedPregnant females
  • AddedSmokers
Sep 30, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionQuality of Newly Formed Bone Assessed by Descriptive Histological Analysis of the Core Biopsy: how it is measured was reworded
Sep 30, 2026
Secondary outcomes
4 edited
What changed in the outcomes
  • EditedPercentage of newly formed boneNewly Formed Bone (% of Total Biopsy Area)Time frame: 6 months after augmentation
  • EditedPercentage of residual graft materialResidual Graft Material (% of Total Biopsy Area)Time frame: 6 months after augmentation
  • EditedPercentage of soft tissueSoft Tissue (% of Total Biopsy Area)Time frame: 6 months after augmentation
  • EditedInflammatory cell infiltration scoreCell Infiltration ScoreTime frame: 6 months after augmentation
Sep 30, 2026
Contact
Study contact changed: a•••@msa.edu.eg→a•••@msa.edu.eg · •••0001. See the current contact
Sep 30, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • October University for Modern Sciences and Arts (MSA), Faculty of Dentistry · Giza, EgyptContact a•••@msa.edu.eg · •••0001→a•••@msa.edu.eg · •••0001Contact person changed (no phone or email listed)Contact person changed (no phone or email listed)Contact person changed (no phone or email listed)
Sep 30, 2026
Registered
First appeared on the registry
Sep 25, 2026
Show all 2 updates
  1. Sep 30, 2026
    Eligibility 4 inclusion criteria edited; 1 exclusion criterion edited, 2 added, 2 removed
    What changed in the criteria
    Inclusion criteria
    • EditedAdults olderAge more than 21 years old
    • EditedHorizontal bone defectloss in the lower posterior area (Seibert Class I) in the posterior mandible
    • EditedEnough inter-arch space for anplacement of implant-supported prosthesis
    • EditedMotivated patient to receivehave the treatment
    Exclusion criteria
    • EditedSystemicPatients with systemic conditions that could interfere with the healing process
    • RemovedPregnancy
    • RemovedSmoking
    • AddedPregnant females
    • AddedSmokers
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionQuality of Newly Formed Bone Assessed by Descriptive Histological Analysis of the Core Biopsy: how it is measured was reworded
    Secondary outcomes 4 edited
    What changed in the outcomes
    • EditedPercentage of newly formed boneNewly Formed Bone (% of Total Biopsy Area)Time frame: 6 months after augmentation
    • EditedPercentage of residual graft materialResidual Graft Material (% of Total Biopsy Area)Time frame: 6 months after augmentation
    • EditedPercentage of soft tissueSoft Tissue (% of Total Biopsy Area)Time frame: 6 months after augmentation
    • EditedInflammatory cell infiltration scoreCell Infiltration ScoreTime frame: 6 months after augmentation
    Contact Study contact changed: a•••@msa.edu.eg→a•••@msa.edu.eg · •••0001. See the current contact
    Site contacts Changed at 1 site. See the sites
    Show the site
    • October University for Modern Sciences and Arts (MSA), Faculty of Dentistry · Giza, EgyptContact a•••@msa.edu.eg · •••0001→a•••@msa.edu.eg · •••0001Contact person changed (no phone or email listed)Contact person changed (no phone or email listed)Contact person changed (no phone or email listed)
    + 1 other change: description
  2. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07841158
Lead sponsor
Mohammed Mahmoud Abed
Responsible party
Mohammed Mahmoud Abed (Master's Candidate, Faculty of Dentistry, October University for Modern Sciences and Arts) — Sponsor-investigator
First posted
Sep 25, 2026
Start date
Mar 15, 2025
Primary completion
May 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Mohammed Mahmoud Abed, BDS
Contact
mohammed.mahmoud12@msa.edu.eg
00201118322238
Ahmed Reda Abd Elrahman, PhD
Contact
arrahman@msa.edu.eg
00201206960001
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)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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