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临床试验/NCT07814794
NCT07814794尚未招募不适用

Augmented Reality-assisted Dental Treatments

University of Bari Aldo Moro1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
Accuracy of Osteotomies and Odontotomies Assessed by Linear and Angular Deviation from the Preoperative Surgical Plan

研究概览

简要总结

This study aims to evaluate the accuracy of augmented reality (AR)-assisted dental procedures. Patient-specific anatomical data will be acquired using cone-beam computed tomography (CBCT) and intraoral scanning and integrated to create a three-dimensional virtual model for treatment planning. Different dental procedures, including tooth extractions, dental implant placement, and orthodontic procedures, will be virtually planned before treatment. During the clinical procedure, the planned anatomical and procedural information will be visualized through an AR system, providing real-time guidance to the operator. The accuracy of AR-assisted treatment will be assessed by comparing the preoperative virtual plan with the postoperative clinical outcome, evaluating deviations between planned and achieved results.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Good health according to the System of the American Society of Anesthesiology
  • Aged older than 18 years
  • No general medical contraindication for surgery or orthodontics

排除标准

  • Smoking more than 15 cigarettes a day
  • Pregnancy
  • Acute infections

研究组 & 干预措施

Patients requiring dental treatment

Experimental

Patients requiring dental treatment, including tooth extraction, dental implant placement, or orthodontic treatment, for whom CBCT imaging and intraoral scanning are clinically indicated and who are eligible for augmented reality-assisted treatment.

干预措施: Surgery (Procedure)

Patients requiring dental treatment

Experimental

Patients requiring dental treatment, including tooth extraction, dental implant placement, or orthodontic treatment, for whom CBCT imaging and intraoral scanning are clinically indicated and who are eligible for augmented reality-assisted treatment.

干预措施: Patients requiring orthodontic treatment. (Procedure)

结局指标

主要结局

Accuracy of Osteotomies and Odontotomies Assessed by Linear and Angular Deviation from the Preoperative Surgical Plan

时间窗: 1 month

Postoperative imaging will be superimposed on the preoperative virtual surgical plan, and the deviation between the planned and achieved osteotomy/odontotomy will be quantified. Accuracy will be assessed using linear deviation, expressed in millimeters (mm), and, where applicable, angular deviation, expressed in degrees (°). Measurements will include the discrepancy in the position, extent, and orientation of the performed surgical cuts relative to the corresponding planned cuts. For each osteotomy or odontotomy, the measured deviations will be recorded and summarized using descriptive statistics, including mean, standard deviation, median, range, and 95% confidence intervals, as appropriate.

Accuracy of Freehand Three-Dimensional Orthodontic Bracket Positioning Assessed by Linear and Angular Deviations from the Planned Position

时间窗: 1 month

The accuracy of freehand orthodontic bracket placement will be evaluated by comparing the clinically achieved bracket position with the predefined three-dimensional virtual bracket position. Digital models obtained after bracket placement will be superimposed on the corresponding preoperative digital models or virtual treatment plan. Three-dimensional discrepancies between the planned and achieved bracket positions will be quantified for each bracket. Accuracy will be assessed using linear deviations, expressed in millimeters (mm), along the mesiodistal, occlusogingival, and buccolingual axes, as well as angular deviations, expressed in degrees (°), including tip, torque, and rotational discrepancies. For each bracket, the measured deviations will be recorded and summarized using descriptive statistics, including mean, standard deviation, median, range, and 95% confidence intervals, as appropriate. Aggregate values may also be calculated at the patient and study-group levels.

次要结局

未报告次要终点

研究者

发起方
University of Bari Aldo Moro
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe D'Albis

Principal investigator

University of Bari Aldo Moro

研究点 (1)

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