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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Mohammed Mahmoud Abed, BDS
- 電話番号：00201118322238
- メール：mohammed.mahmoud12@msa.edu.eg
研究連絡先のバックアップ
- 名前：Ahmed Reda Abd Elrahman, PhD
- 電話番号：00201206960001
- メール：arrahman@msa.edu.eg
研究場所
-
-
Giza Governorate
-
Giza、Giza Governorate、エジプト
- 募集
- October University for Modern Sciences and Arts (MSA), Faculty of Dentistry
-
コンタクト：
- Mohammed Mahmoud Abed, BDS
- 電話番号：00201118322238
- メール：mohammed.mahmoud12@msa.edu.eg
-
コンタクト：
- Ahmed Reda Abd Elrahman, PhD
- 電話番号：00201206960001
- メール：arrahman@msa.edu.eg
-
副調査官：
- Ahmed Reda Abd Elrahman, PhD
-
主任研究者：
- Mohammed Mahmoud Abed, BDS
-
副調査官：
- Nada Abdelmonem Zazou, PhD
-
副調査官：
- Mahmoud Ibrahim Nassar, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of Newly Formed Bone Assessed by Descriptive Histological Analysis of the Core Biopsy
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Newly Formed Bone (% of Total Biopsy Area)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Nada Abdelmonem Zazou, PhD、October University for Modern Sciences and Arts (MSA)
- スタディチェア：Ahmed Reda Abd Elrahman, PhD、October University for Modern Sciences and Arts (MSA)
- スタディディレクター：Mahmoud Ibrahim Nassar, PhD、October University for Modern Sciences and Arts (MSA)
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- REC-D 6206-5
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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