About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with systemic conditions that could interfere with the healing process
Pregnant females
Smokers
Poor oral hygiene
Trial design
Single group
Treatments tested in this trial
Customized porous zirconia shell
DeviceA 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
Percentage of Newly Formed Bone (% of Total Biopsy Area)
Histomorphometric measurement of the new bone area as a percentage of the total biopsy area.
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.
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mohammed Mahmoud Abed
Lead sponsor
October University for Modern Sciences and Arts
Sponsor institution