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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Quality of Newly Formed Bone Assessed by Descriptive Histological Analysis of the Core Biopsy
研究概览
简要总结
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 bovine bone graft
- 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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults older than 21 years
- •Horizontal bone defect (Seibert Class I) in the posterior mandible
- •Enough inter-arch space for an implant-supported prosthesis
- •Motivated to receive the treatment
- •Good oral hygiene
排除标准
- •Systemic conditions that could interfere with healing
- •Pregnancy
- •Poor oral hygiene
研究组 & 干预措施
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.
干预措施: Customized porous zirconia shell (Device)
结局指标
主要结局
Quality of Newly Formed Bone Assessed by Descriptive Histological Analysis of the Core Biopsy
时间窗: 6 months after ridge augmentation (at shell removal and implant placement)
Qualitative histological assessment of the core bone biopsy harvested from the augmented site. Biopsies will be fixed in 10% formalin, processed and examined under light microscopy. The tissue structure of the augmented site will be described (Dellavia et al., 2021). Results will be reported as the number of participants whose biopsy shows newly formed bone in continuity with the native bone.
次要结局
- Percentage of newly formed bone(6 months after augmentation)
- Percentage of residual graft material(6 months after augmentation)
- Percentage of soft tissue(6 months after augmentation)
- Inflammatory cell infiltration score(6 months after augmentation)
研究者
Mohammed Mahmoud Abed
Master's Candidate, Faculty of Dentistry
October University for Modern Sciences and Arts