Exploration of Diagnosis, Etiology, and Prognosis Prediction of Cracked Teeth in Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity of NIRI for Detecting Cracked Teeth
研究概览
简要总结
Cracked teeth are a common dental problem where tiny cracks form in the teeth. These cracks can be hard to find early, and if not treated, they may cause the tooth to break. This study aims to see if a new, non-invasive imaging method called Near-Infrared Imaging (NIRI) can help us find these cracks better in young adults aged 18 to 30 years. Participants will attend a single dental visit where they will receive a standard dental examination, including checks for pain when biting or when the tooth is tapped or exposed to cold. Additionally, pictures of their teeth will be taken using a special NIRI camera that uses a safe, painless light, and their teeth will be examined closely using a dental operating microscope, which is the current standard method for comparison. The main goals are to evaluate how accurate the NIRI method is compared to the microscope, to determine if NIRI can serve as a reliable alternative or helpful supplement for dentists, and to identify patterns and factors such as tooth position, wear, and bite that may be linked to cracked teeth, helping dentists recognize patients at higher risk. The study enrolled participants from September 2025 to March 2026 at the School and Hospital of Stomatology, Fujian Medical University.
详细描述
The diagnosis of cracked teeth relies heavily on subjective clinical findings, including patient-reported pain upon biting, cold sensitivity, and visual inspection under magnification. However, these methods lack objective quantifiable measures, often leading to delayed or missed diagnoses. Near-Infrared Imaging (NIRI) has emerged as a promising non-invasive imaging modality that can detect subtle structural changes in tooth hard tissues. This study is designed to systematically evaluate the diagnostic utility of NIRI in detecting cracked teeth among young adults, using the dental operating microscope (OM) combined with clinical examination as the reference standard. This study was designed as a prospective, self-controlled, diagnostic accuracy trial. All participants underwent both diagnostic examinations: the index test was near-infrared imaging (NIRI) and the reference standard was operating microscope (OM) combined with conventional clinical examination.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 30 years old Presence of ≥20 natural teeth that are either unrestored or have minor restorations Willingness to provide written informed consent Capability to cooperate with clinical oral examination and NIRI scanning
排除标准
- •Presence of <20 natural teeth History of radiotherapy or surgery in the maxillofacial region Inability to cooperate with clinical examinations or questionnaire surveys History of facial trauma Undergoing orthodontic treatment
研究组 & 干预措施
Young Adult Study Cohort
This group includes young adults aged 18 to 30 years who are enrolled in this diagnostic study. All participants will undergo a comprehensive baseline oral examination, including assessment of occlusion, tooth wear, restoration status, and clinical symptoms such as biting pain, cold-stimulus pain, and percussion pain. Each participant's teeth will be examined sequentially using Near-Infrared Imaging (NIRI) and a dental operating microscope (OM), with examiners blinded to each other's results. No intervention is administered; all assessments are observational and non-invasive.
干预措施: Observational Assessment Only (Other)
结局指标
主要结局
Sensitivity and Specificity of NIRI for Detecting Cracked Teeth
时间窗: At baseline upon completion of oral examinations
Sensitivity and specificity of Near-Infrared Imaging (NIRI) for detecting cracked teeth, using dental operating microscope (OM) examination as the reference standard. Calculated at both the tooth level and the patient level with 95% confidence intervals.
Positive and Negative Predictive Values of NIRI for Detecting Cracked Teeth
时间窗: At baseline upon completion of oral examinations
Positive predictive value (PPV) and negative predictive value (NPV) of Near-Infrared Imaging (NIRI) for detecting cracked teeth, using dental operating microscope (OM) examination as the reference standard. Calculated at both the tooth level and the patient level with 95% confidence intervals.
Area Under the ROC Curve (AUC) of NIRI for Detecting Cracked Teeth
时间窗: At baseline upon completion of oral examinations
Overall discriminative ability of Near-Infrared Imaging (NIRI) assessed by the area under the receiver operating characteristic curve (AUC), with 95% confidence intervals at both the tooth and patient levels.
次要结局
- Diagnostic Agreement Between NIRI and Operating Microscope（OM）(At baseline upon completion of oral examinations)
- Patient-Level Prevalence of Cracked Teeth(At baseline upon completion of oral examinations)
- Crack Status and NIRI Diagnostic Performance by Tooth Position(At baseline upon completion of oral examinations)
- Crack Status and NIRI Diagnostic Performance by Tooth Wear(At baseline upon completion of oral examinations)
- Crack Status and NIRI Diagnostic Performance by Clinical Symptoms(At baseline upon completion of oral examinations)
- Crack Status and NIRI Diagnostic Performance by Caries and Restoration Status(At baseline upon completion of oral examinations)
- Crack Status and NIRI Diagnostic Performance by Special Dental Conditions(At baseline upon completion of oral examinations)
- Patient-Level Crack Status and NIRI Diagnostic Performance by Occlusal Factors(At baseline upon completion of oral examinations)
研究者
Hao Yu
Chief Physician Associate Professor
Fujian Medical University