Impact of an Artificial Intelligence-Based Chatbot on Implant Patient Management: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Plaque Index (PI) Score at Implant Sites
研究概览
简要总结
Background: Dental implant therapy is a well-established and predictable procedure for replacing missing teeth, with high long-term survival rates. However, poor oral hygiene remains one of the main modifiable risk factors for peri-implant diseases such as mucositis and peri-implantitis.
Objective: The aim of this randomized controlled clinical trial is to evaluate the effectiveness of an artificial intelligence (AI)-based chatbot, developed and validated by dental experts, in improving oral hygiene and clinical outcomes in patients with implant-supported restorations, compared to traditional educational methods such as printed leaflets and dental hygienist sessions.
Methods: A total of 110 adult patients rehabilitated with dental implants were randomly assigned to either an AI chatbot intervention group or a control group receiving standard oral hygiene education. The chatbot provides continuous, personalized education and motivation through natural language interaction. Clinical and radiographic parameters, including plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD), and marginal bone loss (MBL), were recorded at baseline and at follow-up visits.
Expected outcomes: It is hypothesized that the use of an AI-based chatbot will significantly improve oral hygiene compliance and clinical outcomes compared to conventional methods.
Significance: The study aims to demonstrate the potential of AI-assisted patient education in promoting long-term peri-implant health and preventing peri-implant diseases.
详细描述
Rationale and Background:
Dental implant therapy is highly successful, but peri-implant diseases, primarily caused by inadequate plaque control, remain a major cause of implant failure. Conventional oral hygiene education methods, such as verbal instructions and printed materials, often fail to ensure long-term patient compliance. Artificial intelligence (AI)-based chatbots, powered by large language models, offer a new way to provide continuous, personalized education and motivation to patients. Although their potential has been explored in orthodontics, little is known about their role in peri-implant maintenance.
Study Objective:
This randomized controlled clinical trial investigates whether an AI-based chatbot developed by dental experts can improve oral hygiene compliance and peri-implant health compared to traditional educational methods.
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy or with controlled systemic conditions;
- •Good periodontal health on either an intact or reduced periodontium;
- •Regular adherence to supportive periodontal therapy (SPT);
- •Presence of at least one osseointegrated dental implant in the maxilla or mandible, following transmucosal healing for 2-4 months;
- •Daily access to a smartphone.
排除标准
- •Age < 18 years;
- •Untreated or active periodontal disease;
- •Currently undergoing orthodontic therapy;
- •Patients with cognitive deficits;
- •Smoking habit (more than 10 cigarettes per day);
- •History of heavy alcohol consumption;
- •Use of immunosuppressive medication;
- •Pregnancy or lactation.
结局指标
主要结局
Plaque Index (PI) Score at Implant Sites
时间窗: Baseline (prosthetic loading of implant) and 6 months after intervention start.
The PI is considered a direct indicator of the quality of oral hygiene at home and reflects the level of plaque control achieved by each participant. Measurements will be recorded using a standard four-grade scale (0-3) at six sites per implant by a blinded examiner.
Plaque Index (PI) Score at Implant Sites
时间窗: Baseline (prosthetic loading of implant) and 6 months after intervention start.
The PI is considered a direct indicator of the quality of oral hygiene at home and reflects the level of plaque control achieved by each participant. Measurements will be recorded using a standard four-grade scale (0-3) at six sites per implant by a blinded examiner.
次要结局
- Presence of Bleeding on Probing (BOP) at Implant Sites(Baseline (prosthetic loading of implant) and 6 months after intervention start.)
- Presence of Suppuration on Probing (SUP) at Implant Sites(Baseline (prosthetic loading of implant) and 6 months after intervention start.)
- Presence of Bleeding on Probing (BOP) at Implant Sites(Baseline (prosthetic loading of implant) and 6 months after intervention start.)
- Presence of Suppuration on Probing (SUP) at Implant Sites(Baseline (prosthetic loading of implant) and 6 months after intervention start.)
- Marginal Bone Loss (MBL) in Millimeters at Implant Sites(Baseline (prosthetic loading of implant) and 6 months after intervention start.)
研究者
Marco Cicciù
Full Professor
University of Catania