NCT07092592尚未招募不适用
Developing an Optical Coherence Tomography (OCT) Based Handheld Intraoral Scanner for Dentistry
Perceptive Technologies, Inc1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年8月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Intra-method reliability/repeatability testing
研究概览
简要总结
The goal of this study is to optimize the matching between Optical Coherence Tomography (OCT) imaging and the true anatomy of the tooth. It also non-invasively tests how reliable the OCT scanner can access tissue integrity, measure depth, and detect texture features. These features will be important to plan for treatment. The specific aims of this study are:
- to correct for distortion caused by internal refractive indices to restore true tooth anatomy
- to test the feasibility and usability of the full-motion OCT scanner in volunteers.
Participants may be in one of the following groups
- Some teeth that are extracted according standard treatment plan will be scanned with OCT.
- Some participants will have their teeth and gum in the mouths scanned by OCT
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Willing and able to agree by the terms of the consent form and sign the Informed Consent form
- •Aged 18 years old and older
- •Individuals with a minimum of 18 natural teeth present including teeth from distinct groups (molar, premolar and anterior teeth).
- •Having healthy dentition (small carious lesions and dental restorations not covering the entire surface of the tooth will be accepted) as determined by the dental clinician
- •Willing to have a retraction cord placed under the gumline for a duration of 2 min.
- •Having a tooth that requires crown procedure according to treatment planning by the patients' clinician (for real-time scanning)
排除标准
- •Pregnant women
- •Generalized gingivitis and periodontal disease
- •Extensive dental work including dental fillings, crowns and implants and extensive tooth damage (i.e., fracture, large dental caries, etc.)
- •Presence of fixed orthodontic braces, or lingual bars (only for in vivo studies)
- •Presence of generalized (or on target teeth) supra and subgingival calculus
结局指标
主要结局
Intra-method reliability/repeatability testing
时间窗: Up to 24 weeks
Intra-class correlation coefficients will be calculated for tissue characteristics listed above will be determined by the OCT scanner on group of teeth (full-arch), single tooth and subgingival surfaces.
次要结局
- Structure assessments(Up to 24 weeks)
研究者
研究点 (1)
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