Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation Using Customized Porous Zirconia Shell
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?
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
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Mohammed Mahmoud Abed, BDS
- 电话号码：00201118322238
- 邮箱：mohammed.mahmoud12@msa.edu.eg
研究联系人备份
- 姓名：Ahmed Reda Abd Elrahman, PhD
- 电话号码：00201206960001
- 邮箱：arrahman@msa.edu.eg
学习地点
-
-
Giza Governorate
-
Giza、Giza Governorate、埃及
- 招聘中
- October University for Modern Sciences and Arts (MSA), Faculty of Dentistry
-
接触：
- Mohammed Mahmoud Abed, BDS
- 电话号码：00201118322238
- 邮箱：mohammed.mahmoud12@msa.edu.eg
-
接触：
- Ahmed Reda Abd Elrahman, PhD
- 电话号码：00201206960001
- 邮箱：arrahman@msa.edu.eg
-
副研究员：
- Ahmed Reda Abd Elrahman, PhD
-
首席研究员：
- Mohammed Mahmoud Abed, BDS
-
副研究员：
- Nada Abdelmonem Zazou, PhD
-
副研究员：
- Mahmoud Ibrahim Nassar, PhD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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:
- Patients with systemic conditions that could interfere with the healing process
- Pregnant females
- Smokers
- Poor oral hygiene
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of Newly Formed Bone Assessed by Descriptive Histological Analysis of the Core Biopsy
大体时间：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). |
6 months after ridge augmentation (at shell removal and implant placement)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Newly Formed Bone (% of Total Biopsy Area)
大体时间：6 months after augmentation
|
Histomorphometric measurement of the new bone area as a percentage of the total biopsy area. |
6 months after augmentation
|
|
Percentage of Residual Graft Material (% of Total Biopsy Area)
大体时间：6 months after augmentation
|
Histomorphometric measurement of the remaining graft particle area as a percentage of the total biopsy area. |
6 months after augmentation
|
|
Percentage of Soft Tissue (% of Total Biopsy Area)
大体时间：6 months after augmentation
|
Histomorphometric measurement of the non-mineralized connective tissue area as a percentage of the total biopsy area. |
6 months after augmentation
|
|
Inflammatory Cell Infiltration Score
大体时间：6 months after augmentation
|
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. |
6 months after augmentation
|
合作者和调查者
调查人员
- 研究主任：Nada Abdelmonem Zazou, PhD、October University for Modern Sciences and Arts (MSA)
- 学习椅：Ahmed Reda Abd Elrahman, PhD、October University for Modern Sciences and Arts (MSA)
- 研究主任：Mahmoud Ibrahim Nassar, PhD、October University for Modern Sciences and Arts (MSA)
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- REC-D 6206-5
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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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