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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorMohammed Mahmoud Abed

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Customized porous zirconia shell

    Device

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Customized Porous Zirconia ShellExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

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