Artificial Intelligence-Guided Versus Manual CBCT Planning for Immediate Implant Placement in Molar Extraction Sites: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Immediate implant feasability
研究概览
简要总结
This study evaluates whether artificial intelligence (AI)-based analysis of cone-beam computed tomography (CBCT) scans can support clinical decision-making for immediate dental implant placement in molar extraction sites.
When a molar tooth is removed, placing a dental implant immediately may reduce treatment time and preserve surrounding bone. However, immediate implant placement is not always possible and depends on the anatomy of the extraction socket, particularly the interradicular septum (the bone between the roots). CBCT imaging is routinely used to assess this anatomy before surgery. Traditionally, radiologists manually evaluate these scans. Recently, AI-based tools have been developed to automatically analyze CBCT images.
In this randomized controlled trial, patients requiring molar extraction and potential immediate implant placement will be assigned to one of two planning approaches: AI-guided CBCT assessment or conventional manual CBCT assessment. The operating surgeon will use the assigned planning report to guide treatment decisions.
The primary outcome of the study is the feasibility of immediate implant placement, defined as successful implant placement with achievement of primary stability during surgery. Secondary outcomes include surgical time, need for changes to the treatment plan, and implant stability measurements.
The goal of this study is to determine whether AI-assisted CBCT analysis performs similarly to, or improves upon, conventional manual radiologic assessment in supporting safe and effective immediate implant placement.
详细描述
This study is a prospective, parallel-arm, randomized controlled clinical trial designed to evaluate the clinical impact of artificial intelligence (AI)-based CBCT analysis on decision-making for immediate implant placement in molar extraction sites.
Following eligibility confirmation and informed consent, participants requiring molar extraction with potential immediate implant placement will undergo standardized preoperative cone-beam computed tomography (CBCT) imaging. Participants will be randomly allocated in a 1:1 ratio to one of two planning workflows:
AI-guided planning arm: CBCT scans will be analyzed using a pre-specified, locked AI-based segmentation and socket assessment model. The AI system will quantify interradicular septum dimensions and generate a feasibility classification based on predefined anatomical criteria.
Manual planning arm: CBCT scans will undergo conventional manual segmentation and assessment by an experienced radiologist using the same predefined anatomical criteria for feasibility determination.
In both arms, feasibility recommendations will be based on identical, prospectively defined decision thresholds to ensure comparability between planning methods. The operating surgeon will receive only the planning report corresponding to the assigned allocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults≥18 years are able to provide informed consent. Indicated for the extraction of a molar tooth (maxillary or mandibular) with planned implant-supported rehabilitation.
- •Candidate for immediate implant placement attempt based on preoperative clinical evaluation and CBCT availability.
- •Preoperative CBCT will be acquired using the study imaging protocol within a defined window (e.g., ≤4 weeks before surgery).
- •Adequate oral hygiene and periodontal condition compatible with implant surgery (e.g., treated/stable periodontal status per clinician judgement).
排除标准
- •Pregnancy or breastfeeding (due to imaging/surgical considerations).
- •Uncontrolled systemic disease or medical contraindication to oral surgery/implant placement (e.g., uncontrolled diabetes, immunosuppression as judged by clinician).
- •History of head and neck radiotherapy in the implant region. Use of medications associated with compromised bone healing where immediate implant placement is not advised (e.g., high-dose antiresorptives/IV bisphosphonates; you can specify per your clinic policy).
- •Acute uncontrolled infection at the site requiring staged management (e.g., spreading cellulitis/abscess) or other condition precluding immediate placement per surgeon judgement.
- •Need for simultaneous major augmentation that precludes immediate implant placement (e.g., extensive ridge reconstruction planned at the same surgery rather than socket-level grafting).
- •Inadequate CBCT quality for segmentation/measurement (motion artifacts, incomplete field of view, or metal artifact obscuring the septum).
研究组 & 干预措施
AI assisted CBCT
Participants randomized to this arm will undergo preoperative cone-beam computed tomography (CBCT) imaging as part of standard diagnostic workup for molar extraction with potential immediate implant placement.
CBCT datasets will be processed using a pre-specified, locked artificial intelligence (AI)-based segmentation and socket assessment model. The AI system will automatically segment the extraction socket anatomy, quantify interradicular septum dimensions, and generate a structured feasibility assessment according to predefined anatomical decision thresholds established in the study protocol.
A standardized AI-generated planning report, including septum measurements and feasibility classification, will be provided to the operating surgeon prior to surgery. The surgeon will use this report to guide preoperative planning and intraoperative decision-making.
Surgical procedures will be performed according to a standardized surgical protocol. Immediate implant placement will be attempte
干预措施: AI assisted CBCt (Device)
Manual CBCT segmented
Participants randomized to this arm will undergo preoperative CBCT imaging as part of the standard diagnostic workup for molar extraction with potential immediate implant placement.
CBCT datasets will be evaluated using conventional manual segmentation and radiologic assessment performed by an experienced radiologist. Interradicular septum dimensions and socket morphology will be assessed according to predefined anatomical criteria specified in the study protocol. Feasibility for immediate implant placement will be determined using the same prospectively defined decision thresholds applied in the intervention arm.
A standardized manual planning report, including septum measurements and feasibility classification, will be provided to the operating surgeon before surgery. The surgeon will use this report to guide preoperative planning and intraoperative decision-making.
Surgical procedures will be performed according to the same standardized surgical protocol
干预措施: Manual CBCT segmentation (Procedure)
结局指标
主要结局
Immediate implant feasability
时间窗: During the implant surgery-intra operative after flap elevation
Proportion of sites with successful immediate implant placement with primary stability at the index surgery (feasible vs not feasible).
次要结局
- Planning time (minutes)(Preoperative before the surgery)
研究者
Mihad Ibrahim
Clinical researcher
Shalash Dental education