Investigation of the Orthodontic and Articular Effects of the One-Step No-Prep Protocol
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
- Three-dimensional orthodontic tooth movements (linear)
研究概览
简要总结
This study investigates how the One-Step No-Prep protocol with orthodontic assistance affects dental and jaw function in adults treated for localized tooth wear. It focuses on the predictability and extent of orthodontic tooth movements, the impact on temporomandibular joint position and function, and the quality and long-term stability of the restored bite.
Participants will receive minimally invasive bonded restorations combined with simple orthodontic mechanics. The study will evaluate changes in tooth position, bite contacts, facial vertical height, and temporomandibular joint function using digital scans, low-dose 3D imaging, jaw-tracking, and clinical examinations. Patient comfort, function, and satisfaction will also be assessed through questionnaires.
The goal is to better understand how this conservative treatment performs over time.
详细描述
This study evaluates the clinical, orthodontic, and functional outcomes of the One-Step No-Prep protocol with orthodontic assistance (OSNPO) in adult patients presenting with localized tooth wear. The OSNPO approach combines bonded restorations placed without tooth preparation and controlled orthodontic extrusion to re-establish posterior occlusion. Although the protocol has shown promising clinical results, several key aspects have not yet been quantified or documented systematically.
The study includes both prospective and retrospective participants treated at the University Hospital of Liège. Prospective cases undergo standardized digital assessments, including intraoral scanning, low-dose cone-beam CT, and 3D jaw-tracking, while retrospective cases contribute long-term clinical and occlusal data. Follow-up extends to 5 years, with an additional evaluation at 10 years.
The primary focus is to characterize the nature and magnitude of orthodontic tooth movements, the time required to regain full occlusion, and the short- and long-term stability of occlusal contacts after treatment. Additional analyses examine changes in vertical facial dimensions, as well as temporomandibular joint position and function before and after treatment. Secondary outcomes include the clinical performance of PICN restorations and patient-reported measures of comfort, function, esthetics, and quality of life.
By integrating digital imaging, functional analysis, and patient-centered outcomes, this study aims to clarify the biological mechanisms underlying OSNPO, identify predictors of treatment duration and stability, and support evidence-based use of this minimally invasive protocol in the management of tooth wear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Localized tooth wear that will be treated, or has already been treated, using the OSNPO protocol.
- •Age 18 years or older.
- •Sufficient cognitive ability to understand the study procedures and complete the required assessments.
- •Ability to read and complete the study questionnaires in French.
- •Written informed consent provided.
排除标准
- •No exclusion criteria.
研究组 & 干预措施
Post-Treatment CBCT, Intraoral Scan, and Modjaw Assessment
All participants treated with the OSNPO protocol undergo additional diagnostic assessments performed specifically for research purposes after completion of their routine clinical treatment.
These research-only procedures include:
- a low-dose, large-field CBCT scan to evaluate tooth movements, vertical facial dimensions, and temporomandibular joint position;
- a digital intraoral scan to document occlusal contacts and dental morphology;
- a Modjaw 3D jaw-tracking recording to assess mandibular function and occlusal dynamics.
干预措施: Low-dose Cone-Beam Computed Tomography (Radiation)
结局指标
主要结局
Three-dimensional orthodontic tooth movements (linear)
时间窗: Baseline and end of OSNPO treatment (approximately 1 month)
Quantification of three-dimensional dental movements induced by the OSNPO protocol, including linear changes assessed on cone-beam computed tomography. Unit of measure : Millimeters (mm).
Three-dimensional orthodontic tooth movements (angular)
时间窗: Baseline and end of OSNPO treatment (approximately 1 month)
Quantification of three-dimensional dental movements induced by the OSNPO protocol, including angular changes assessed on cone-beam computed tomography. Unit of measure : Degrees (°).
Time required to re-establish functional occlusion
时间窗: Baseline and end of OSNPO treatment (approximately 1 month)
Assessment of the duration needed to re-establish a functional occlusion following OSNPO, considering the initial posterior open bite and the orthodontic mechanics applied.
Occlusal contacts
时间窗: Baseline; 1 month; annually up to 5 years; and at 10 years.
Assessment of the number of occlusal contacts
Occlusal contacts stability
时间窗: Baseline; 1 month; annually up to 5 years; and at 10 years.
Assessment of the stability of occlusal contacts over time
Changes in vertical facial height
时间窗: Baseline and end of OSNPO treatment (approximately 1 month)
Assessment of the variation in vertical facial height induced by the OSNPO protocol, measured on cone-beam computed tomography. The assessment includes linear measurements between anatomical landmarks.
Temporomandibular joint position
时间窗: Baseline and end of OSNPO treatment (approximately 1 month)
Assessment of the changes in temporomandibular joint position following the OSNPO protocol. Joint position is evaluated using cone-beam computed tomography, with measurements between anatomical landmarks.
Temporomandibular joint function
时间窗: Baseline and end of OSNPO treatment (approximately 1 month)
Assessment of the changes in temporomandibular joint function following the OSNPO protocol assessed using the Modjaw jaw-tracking system. Functional evaluation includes three-dimensional mandibular dynamics recorded during different mandibular movements, captured in real time. Unit of measure : Movement amplitudes in millimeters (mm)
次要结局
- Clinical performance of PICN partial restorations(1 month; annually up to 5 years; 10 years.)
- Longevity of PICN partial restorations(1 month; annually up to 5 years; 10 years.)
- Oral health-related quality of life (OHIP-49)(Baseline; weekly during orthodontic treatment; 1 month; annually up to 5 years; 10 years.)
- Musculoskeletal symptoms(Baseline; 1 month; annually up to 5 years; 10 years.)
- Patient satisfaction(1 month)
研究者
Mainjot Amélie
Professor
Centre Hospitalier Universitaire de Liege