Artificial Intelligence Integrated Planning and Evaluation of Novel Fully Guided Autogenous Root Slice Replantation and Fully Guided Socket Shielding in Immediate Esthetic Implant Placement (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Labial Bone Thickness
研究概览
简要总结
The goal of this clinical trial is to learn whether two different tooth-preservation techniques work equally well when placing a dental implant right after a tooth is removed in the front of the mouth (the "esthetic zone"). It will also learn whether using artificial intelligence (AI) to help plan the surgery improves the results.
The main questions it aims to answer are:
- Does keeping part of the root in place using a technique called autogenous root slice replantation work as well as a similar technique called socket shielding, in terms of appearance and gum health around the implant?
- Does AI-guided surgical planning improve accuracy, appearance, and gum health compared with traditional planning?
Researchers will compare participants who receive autogenous root slice replantation to participants who receive the socket-shield technique to see if one produces better outcomes than the other. Both groups will have their implants placed using a 3D-printed surgical guide made from AI-assisted digital planning.
Participants will:
- Have a tooth removed and an implant placed on the same day, using one of the two techniques
- Have their surgery guided by a custom surgical guide, planned with AI assistance
- Return for follow-up visits so researchers can check healing, gum appearance, and how well the implant fits with their smile
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 双盲 (受试者、结局评估者)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Selected patients of both sexes are 20-40 years old.
- Patients are systemically healthy based on questionnaire dental modification of Cornell index.
- Clinical gingival health either on intact or reduced periodontium according to the new classification system (2017). (Lang, N. P. et al., 2018)
- The recipient site of the implant is free from any active pathological conditions.
- Class II extraction socket according to Sabri and Barootchi classification ( Sabri, H. et al., 2024)
- Adequate interocclusal space to accommodate the available restorative components.
- Adequate native/apical bone to achieve primary implant stability.
排除标准
- Pregnant female.
- Parafunctional habits such as bruxism and clenching Patients suffering from periodontitis.
- Smokers.
研究组 & 干预措施
Fully Single Guided Socket Shield
Participants in this arm will undergo the socket-shield technique for immediate implant placement using a single, fully guided digital protocol. Following artificial intelligence (AI)-assisted digital planning, a single surgical guide will direct both the sectioning of the facial root fragment (shield preparation) and the immediate implant osteotomy and placement in one continuous, fully guided sequence. The facial root fragment will be retained to support the labial bone plate and peri-implant soft tissues, while immediate provisionalization will be performed. Participants will be followed to assess implant accuracy, esthetic outcomes, and peri-implant tissue health.
干预措施: Guided socket shield with immediate implant (Procedure)
Fully Single Guided Socket Shield
Participants in this arm will undergo the socket-shield technique for immediate implant placement using a single, fully guided digital protocol. Following artificial intelligence (AI)-assisted digital planning, a single surgical guide will direct both the sectioning of the facial root fragment (shield preparation) and the immediate implant osteotomy and placement in one continuous, fully guided sequence. The facial root fragment will be retained to support the labial bone plate and peri-implant soft tissues, while immediate provisionalization will be performed. Participants will be followed to assess implant accuracy, esthetic outcomes, and peri-implant tissue health.
干预措施: Guided Immediate Implant (Procedure)
Fully Guided Autogenous Root Slicing Replantation
Participants in this arm will undergo the autogenous root slice replantation (ARSR) technique for immediate implant placement using a single, fully guided digital protocol. Following artificial intelligence (AI)-assisted digital planning, a single surgical guide will direct both the sectioning and preparation of the autogenous root slice and the immediate implant osteotomy and placement in one continuous, fully guided sequence. The prepared root slice will be replanted and retained facially within the socket to support the labial bone plate and peri-implant soft tissues, while immediate provisionalization will be performed. Participants will be followed to assess implant accuracy, esthetic outcomes, and peri-implant tissue health.
干预措施: Guided Autogenous Root Slicing Replantation with Immediate Implant (Procedure)
Fully Guided Autogenous Root Slicing Replantation
Participants in this arm will undergo the autogenous root slice replantation (ARSR) technique for immediate implant placement using a single, fully guided digital protocol. Following artificial intelligence (AI)-assisted digital planning, a single surgical guide will direct both the sectioning and preparation of the autogenous root slice and the immediate implant osteotomy and placement in one continuous, fully guided sequence. The prepared root slice will be replanted and retained facially within the socket to support the labial bone plate and peri-implant soft tissues, while immediate provisionalization will be performed. Participants will be followed to assess implant accuracy, esthetic outcomes, and peri-implant tissue health.
干预措施: Guided Immediate Implant (Procedure)
Conventional Bone Augmentation
Participants in this arm will undergo immediate implant placement combined with conventional guided bone grafting to manage any labial bone defects (dehiscence or fenestration), rather than a partial extraction therapy technique. Following artificial intelligence (AI)-assisted digital planning, a single surgical guide will direct the immediate implant osteotomy and placement. Bone graft material and a barrier membrane will be used to restore the labial bone defect at the time of implant placement, and immediate provisionalization will be performed. Participants will be followed to assess implant accuracy, esthetic outcomes, and peri-implant tissue health.
干预措施: Conventional Bone Augmentation with Immediate Implant (Procedure)
Conventional Bone Augmentation
Participants in this arm will undergo immediate implant placement combined with conventional guided bone grafting to manage any labial bone defects (dehiscence or fenestration), rather than a partial extraction therapy technique. Following artificial intelligence (AI)-assisted digital planning, a single surgical guide will direct the immediate implant osteotomy and placement. Bone graft material and a barrier membrane will be used to restore the labial bone defect at the time of implant placement, and immediate provisionalization will be performed. Participants will be followed to assess implant accuracy, esthetic outcomes, and peri-implant tissue health.
干预措施: Guided Immediate Implant (Procedure)
结局指标
主要结局
Labial Bone Thickness
时间窗: through study completion, an average of 1 year
Labial bone plate thickness measured via cone-beam computed tomography (CBCT) to evaluate preservation of the labial bone contour following autogenous root slice replantation (ARSR), socket shield, or conventional bone augmentation.
Marginal Bone Level
时间窗: through study completion, an average of 1 year
Radiographic marginal bone level around the implant, assessed via CBCT, to evaluate crestal bone stability across the three treatment groups.
Accuracy of AI-Assisted Digital Planning
时间窗: through study completion, an average of 1 year
AI-based segmentation of the tooth/root to be sectioned will be compared against human (manual) segmentation using a heat map to quantify the average discrepancy between the two, assessing the accuracy and reliability of AI integration in surgical planni
次要结局
- Bone Density(through study completion, an average of 1 year)
- Peri-Implant Probing Depth(through study completion, an average of 1 year)
- Modified Gingival Index(through study completion, an average of 1 year)
- Modified Plaque Index(through study completion, an average of 1 year)
- Keratinized Tissue Width and Thickness(through study completion, an average of 1 year)
- Pink Esthetic Score (PES) scaled from 0 to 2(through study completion, an average of 1 year)
- White Esthetic Score (WES)(through study completion, an average of 1 year)
- Postoperative Pain (Visual Analog Scale)(through study completion, an average of 1 year)
- AI Utility in Postoperative Follow-Up(through study completion, an average of 1 year)
研究者
Hussein Fathy Mohammad Hussein Abo Elkheir
Assistant Lecturer
Minia University
研究点 (1)
标识符
- NCT 编号
- NCT07845019
- 其他研究编号
- MiniaU128-1322
日期
- 首次提交
- (26天前)
- 首次发布
- (前天)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否