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临床试验/NCT07295964
NCT07295964尚未招募不适用

Influence of AI Driven Software Programs and Digital Occlusal Collision Corrections on the Occlusal Adjustment of 3D-Printed Restorations: A Clinical Trial

National and Kapodistrian University of Athens2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
2
主要终点
Level of adjustment

研究概览

简要总结

In the last decade, progressive developments in computer hardware, software, manufacturing technologies, and dental materials consistently enhanced the use of digital technologies in dentistry. Traditional prosthodontic techniques have relied on manual fabrication processes, which often resulted in challenges such as suboptimal prosthesis fit, compromised occlusal stability, and limited customization options. However, the advent of 3D printing technology has revolutionized the field, offering new possibilities for patient-specific prosthodontic rehabilitation.

An accurate maxillomandibular relationship between the maxillary and mandibular casts is fundamental to prosthodontic practice. In the integration of intraoral scanners (IOSs) for different dental interventions, the accuracy of the digitizing methods recording the maxillomandibular relationship is similarly essential. The maxillomandibular relationship accuracy recorded by using IOSs has been analyzed in various in vitro and clinical studies.

Intraoral digital scans are recorded in an unload condition, with the mouth open, while acquiring the maxillary and the mandibular intraoral scans. This condition changes when capturing the virtual occlusal records at maximum intercuspation position (MIP). Occlusal collisions are caused by the tooth location discrepancy resulting from the periodontal ligament plasticity between the recording of the intraoral digital scans and the virtual occlusal records, as well as from the intraoral scanning distortion and alignment procedures.

Artificial intelligence driven program software and occlusal collisions or mesh interpenetrations tools have been proposed to improve the maxillomandibular relationship of the scanned models. The software programs of the IOSs can automatically eliminate the occlusal collisions present in virtual articulated casts. Similarly, dental computer-aided design (CAD) programs can automatically detect and eliminate occlusal collisions among the articulated intraoral digital scans imported. However, the effect of the occlusal collision corrections performed by using IOSs or CAD programs on the occlusal adjustment of the restorations is unknown.

详细描述

Objectives The goal of this clinical investigation is to assess the impact of occlusal collision corrections performed by the software program of 2 intraoral scanners (TRIOS 4; 3Shape A/S, i700; Medit) and two dental CAD programs (DentalCAD, Rijeka; exocad & Dental System ;3Shape), for maxillomandibular relationship acquired at maximum intercuspation position, on the intraoral occlusal adjustment of 3D-printed restorations. The null hypothesis was that no difference would be found for the intraoral occlusal adjustment of the assessed 3D-printed restorations, designed by the different collision correction methods, independently of the IOS and the dental CAD software.

Materials and methods In total 30 patients are going to be enrolled in the present study. Initially, two intraoral scanners will be used to record the experimental digital scans: TRIOS 4 (TRIOS 4, wireless, v. 22.2.3; 3Shape A/S) and i700 (i700, Medit). Two groups will be established depending on the correction of the occlusal collisions performed by using the IOS software program: not corrected and corrected group. Moreover, 3 subgroups will be established based on the following correction procedures performed in a dental CAD program (DentalCAD, Rijeka; exocad GmbH): no changes, cast trimming (trimming subgroup), opening of the vertical dimension (opening subgroup).

For each record a model-free complete digital workflow will be employed to print a crown using a 3D printer (Pro 2, Sprintray) with a compatible resin (KeyDenture Try-in, KeystoneIndustries). Each restoration is going to be tried and fit intraorally. The sequence of try-in will be randomized. Initially, after adjusting for distal and mesial approximal contact areas, the internal fit will be checked and adjusted to eliminate any interferences in order to ensure the optimal fitting of the restorations. After ensuring optimal fitting, the investigator will take an intraoral quadrant scan including the crown.

The occlusal adjustment strategy will be as follows: Under normal occlusal forces, 8 μm articulating film (AccuFilm, FastCheck, Parkell) will be used consecutively, followed by occlusal contact check using 8 μm articulation foil (Shimstock-foil, Bausch, Cologne, Germany) under strong occlusal forces. Then the occlusal adjustments will be made with fine diamond burs and will polished. After that, the same investigator will take in intraoral digital quadrant scan to record the post-adjustment volume of the each crown.

For the qualitative analysis, color-coded maps of the superimposed pre- and post-adjustment .STL files will be used, utilizing metrology software (Geomagic, 3DSystems). The primary outcome measure will be the volumetric measurement (mm3) of occlusal adjustment amount of the tested 3D printed restorations. The color codes will be standardized in every evaluation, and the occlusal views of color-coded maps will be evaluated by two investigators independently. Less than 0.3 mm differences which were presented in green and yellow, are going to be considered clinically as irrelevant. Meanwhile, turquoise (0.3-04mm), dark blue (0.4-0.5 mm), and red (>0.5 mm) will be taken into consideration for the evaluation. The investigators will rate the adjustment amount 0-4 scores based on the adjustment surface, and the geometrical characteristics of the adjustment. Grade 4 adjustments will be considered to require renewal of the restoration due to a change in the anatomical contour of the reconstructions, whereas Grade 0 will be considered as perfect.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, 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

入选标准

  • Age > 18 years old Absence of painful temporomandibular disorder Presence of opposing teeth Presence of a stable maximum intercuspation relationship

排除标准

  • - Pain in orofacial region Visible periapical lesion < Class II mobility

结局指标

主要结局

Level of adjustment

时间窗: Baseline, after the adjustment of the try-in restorations

The investigators will rate the adjustment amount 0-4 scores based on the adjustment surface, and the geometrical characteristics of the adjustment. Grade 4 adjustments will be considered to require renewal of the restoration due to a change in the anatomical contour of the reconstructions, whereas Grade 0 will be considered as perfect.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Panagiotis Ntovas

PhD Canditate, Department of Operative Dentistry, School of Dentistry, Greece

National and Kapodistrian University of Athens

研究点 (2)

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