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临床试验/NCT05791175
NCT05791175尚未招募不适用

Stress and Tooth Structure Loss in Dental Students. A Prospective, Longitudinal Pilot - Observational Study.

Technische Universität Dresden1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
试验地点
1
主要终点
Evaluation of tooth structure loss and its' progression under stressfull conditons and diverse dietary habits.

研究概览

简要总结

The study is designed as a pilot study. The primary objective of the current study is to collect data on the expression and progression of tooth structure loss in dental students under stressful conditions and different dietary habits using intraoral scanners (IOS). Stress levels will be evaluated using Percived Stress Scale (PSS-10). Eating habits will be queried using reflux and dietary questionnaires. The data obtained will later be used in the case-control design of a multicenter study on the same topic. Conducting the pilot study will allow for a critical evaluation of the study's design, participant retention rate, and recruitment process.

详细描述

The first scan (baseline: T0) is performed during the Dental Prosthetics I course, at the beginning of the 8th semester. Follow-up scans T1 and T2 are performed at the beginning of the 10th semester and after completion of the state examination. The scans are performed by a study doctor or doctoral student using a digital intraoral scanner (Trios, 3 Shape, Denmark). Accompanying the scanning process, study participants will be asked to complete a questionnaire regarding stress levels (PSS) and dietary habits. A medical history and dental findings are also collected. Each scan will take no longer than 10 minutes. The entire examination will take no longer than 45 minutes. The T0 and T1, T2 scans will be overlaid with evaluation software and compared in terms of tooth wear.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • At the time of the baseline examination of the study the participants must be dental students and participate in the Dental Prosthetics Course I in the summer semester 2023, at the Dental School of Medical Faculty Carl Gustav Carus at the Technical University of Dresden
  • Presence of study teeth (at least one antagonist pair of first molars (16/46 or 26/36).
  • Complete dentition, if necessary, dentition with complete gap closure up to the first molar in the maxilla and mandible
  • Presence of a canine guidence
  • Written informed consent of the participating persons

排除标准

  • Age <18 and >40
  • Study teeth restored with dentures
  • Extensive restorations over 1/3 of the occlusal surface on the study teeth
  • Removable dentures
  • Ongoing orthodontic treatment
  • Existing pregnancy/lactation
  • Addiction or other medical conditions that do not allow the subject to understand the nature and scope and possible consequences of the clinical study
  • Indications that the participant is unlikely to comply with the protocol.

结局指标

主要结局

Evaluation of tooth structure loss and its' progression under stressfull conditons and diverse dietary habits.

时间窗: 2 years

Tooth wear will be mesaured in micrometers (µm).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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