Stress and Tooth Structure Loss in Dental Students. (STSLDS)

March 17, 2023 updated by: Technische Universität Dresden

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Department of Dental Prosthetics, Dental Division of the University Hospital Carl Gustav Carus at the Technische Universität Dresden
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study participants will be dental students enrolled in Dental Prosthetics Course I at the beginning of the observation period.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of tooth structure loss and its' progression under stressfull conditons and diverse dietary habits.
Time Frame: 2 years
Tooth wear will be mesaured in micrometers (µm).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Investigators

  • Study Director: Nicole Passia, Prof. Dr., Department of Dental Prosthetics, University Hospital at the Technische Universität Dresden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 20, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DresdenStressDentalStudents

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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