NCT05791175

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Mar 2023Dec 2026

First Submitted

Initial submission to the registry

March 17, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

2.8 years

First QC Date

March 17, 2023

Last Update Submit

March 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Tooth wear will be mesaured in micrometers (µm).

    2 years

Interventions

Intraoral scanner will be use to monitor the changes of the teeth over time. Intraoral scanners are devices that capture three-dimensional images of teeth and are used as an alternative to conventional dental impressions.

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dental Prosthetics, Dental Division of the University Hospital Carl Gustav Carus at the Technische Universität Dresden

Dresden, Saxony, 01307, Germany

Location

Related Publications (22)

  • Abbasi SZ, Mubeen N, Ayub T, Khan MA, Abbasi Z, Baig N. Comparison of stress levels among medical and dental students in the clinical years of training and their coping strategies. J Pak Med Assoc. 2020 Jun;70(6):1006-1008. doi: 10.5455/JPMA.294959.

    PMID: 32810097BACKGROUND
  • Al-Khalifa KS. The Prevalence of Tooth Wear in an Adult Population from the Eastern Province of Saudi Arabia. Clin Cosmet Investig Dent. 2020 Nov 17;12:525-531. doi: 10.2147/CCIDE.S286500. eCollection 2020.

    PMID: 33235511BACKGROUND
  • Bartlett D, Ganss C, Lussi A. Basic Erosive Wear Examination (BEWE): a new scoring system for scientific and clinical needs. Clin Oral Investig. 2008 Mar;12 Suppl 1(Suppl 1):S65-8. doi: 10.1007/s00784-007-0181-5. Epub 2008 Jan 29.

    PMID: 18228057BACKGROUND
  • Bartlett DW, Coward PY, Nikkah C, Wilson RF. The prevalence of tooth wear in a cluster sample of adolescent schoolchildren and its relationship with potential explanatory factors. Br Dent J. 1998 Feb 14;184(3):125-9. doi: 10.1038/sj.bdj.4809560.

    PMID: 9524373BACKGROUND
  • Elani HW, Allison PJ, Kumar RA, Mancini L, Lambrou A, Bedos C. A systematic review of stress in dental students. J Dent Educ. 2014 Feb;78(2):226-42.

    PMID: 24489030BACKGROUND
  • Kuhn M, Turp JC. Risk factors for bruxism. Swiss Dent J. 2018 Feb 12;128(2):118-124. doi: 10.61872/sdj-2018-02-369.

    PMID: 29533049BACKGROUND
  • Mangano F, Gandolfi A, Luongo G, Logozzo S. Intraoral scanners in dentistry: a review of the current literature. BMC Oral Health. 2017 Dec 12;17(1):149. doi: 10.1186/s12903-017-0442-x.

    PMID: 29233132BACKGROUND
  • Marro ML, Aranguiz V, Ramirez V, Lussi A. Prevalence of erosive tooth wear in Chilean adults, 2016: A cross-sectional study. J Oral Rehabil. 2020 Apr;47(4):467-472. doi: 10.1111/joor.12922. Epub 2019 Dec 25.

    PMID: 31834944BACKGROUND
  • Mekhemar M, Attia S, Dorfer C, Conrad J. Dental Students in Germany throughout the COVID-19 Pandemic: A Psychological Assessment and Cross-Sectional Survey. Biology (Basel). 2021 Jul 1;10(7):611. doi: 10.3390/biology10070611.

    PMID: 34356466BACKGROUND
  • Milosevic A. The problem with an epidemiological index for dental erosion. Br Dent J. 2011 Sep 9;211(5):201-3. doi: 10.1038/sj.bdj.2011.722.

    PMID: 21904350BACKGROUND
  • Milosevic Markovic M, Latas MB, Milovanovic S, Poznanovic ST, Lazarevic MM, Karisik MJ, Dordevic J, Mandinic Z, Jovanovic S. Mental Health and Quality of Life among Dental Students during COVID-19 Pandemic: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Oct 28;19(21):14061. doi: 10.3390/ijerph192114061.

    PMID: 36360939BACKGROUND
  • Picos A, Badea ME, Dumitrascu DL. Dental erosion in gastro-esophageal reflux disease. A systematic review. Clujul Med. 2018 Oct;91(4):387-390. doi: 10.15386/cjmed-1017. Epub 2018 Oct 30.

    PMID: 30564013BACKGROUND
  • Polmann H, Reus JC, Massignan C, Serra-Negra JM, Dick BD, Flores-Mir C, Lavigne GJ, De Luca Canto G. Association between sleep bruxism and stress symptoms in adults: A systematic review and meta-analysis. J Oral Rehabil. 2021 May;48(5):621-631. doi: 10.1111/joor.13142. Epub 2021 Jan 28.

    PMID: 33377534BACKGROUND
  • Schlenz MA, Schlenz MB, Wostmann B, Jungert A, Ganss C. Intraoral scanner-based monitoring of tooth wear in young adults: 12-month results. Clin Oral Investig. 2022 Feb;26(2):1869-1878. doi: 10.1007/s00784-021-04162-6. Epub 2021 Sep 8.

    PMID: 34498100BACKGROUND
  • Shellis RP, Addy M. The interactions between attrition, abrasion and erosion in tooth wear. Monogr Oral Sci. 2014;25:32-45. doi: 10.1159/000359936. Epub 2014 Jun 26.

    PMID: 24993256BACKGROUND
  • Smith BG, Knight JK. An index for measuring the wear of teeth. Br Dent J. 1984 Jun 23;156(12):435-8. doi: 10.1038/sj.bdj.4805394. No abstract available.

    PMID: 6590081BACKGROUND
  • Son K, Lee WS, Lee KB. Effect of Different Software Programs on the Accuracy of Dental Scanner Using Three-Dimensional Analysis. Int J Environ Res Public Health. 2021 Aug 10;18(16):8449. doi: 10.3390/ijerph18168449.

    PMID: 34444195BACKGROUND
  • Travassos da Rosa Moreira Bastos R, Teixeira da Silva P, Normando D. Reliability of qualitative occlusal tooth wear evaluation using an intraoral scanner: A pilot study. PLoS One. 2021 Mar 25;16(3):e0249119. doi: 10.1371/journal.pone.0249119. eCollection 2021.

    PMID: 33765042BACKGROUND
  • Wetselaar P, Lobbezoo F. The tooth wear evaluation system: a modular clinical guideline for the diagnosis and management planning of worn dentitions. J Oral Rehabil. 2016 Jan;43(1):69-80. doi: 10.1111/joor.12340. Epub 2015 Sep 1.

    PMID: 26333037BACKGROUND
  • Wetselaar P, Manfredini D, Ahlberg J, Johansson A, Aarab G, Papagianni CE, Reyes Sevilla M, Koutris M, Lobbezoo F. Associations between tooth wear and dental sleep disorders: A narrative overview. J Oral Rehabil. 2019 Aug;46(8):765-775. doi: 10.1111/joor.12807. Epub 2019 May 12.

    PMID: 31038764BACKGROUND
  • Wetselaar P, Wetselaar-Glas MJM, Katzer LD, Ahlers MO. Diagnosing tooth wear, a new taxonomy based on the revised version of the Tooth Wear Evaluation System (TWES 2.0). J Oral Rehabil. 2020 Jun;47(6):703-712. doi: 10.1111/joor.12972. Epub 2020 May 14.

    PMID: 32274827BACKGROUND
  • Yu T, Tao DY, Lu HX, Zhu JL, Xie CY, Bartlett D, Feng XP. Prevalence and Associated Factors of Tooth Wear in Shanghai. Chin J Dent Res. 2021 Jun 23;24(2):95-103. doi: 10.3290/j.cjdr.b1530421.

    PMID: 34219442BACKGROUND

MeSH Terms

Conditions

Tooth Wear

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Nicole Passia, Prof. Dr.

    Department of Dental Prosthetics, University Hospital at the Technische Universität Dresden

    STUDY DIRECTOR

Central Study Contacts

Elzbieta Pacek, Dr.

CONTACT

Katarzyna Kresse-Walczak, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2023

First Posted

March 30, 2023

Study Start

March 20, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations