Tooth WearSTSLDSNCT05791175
Stress and Tooth Structure Loss in Dental Students.
An observational study of Tooth Wear, run by Technische Universität Dresden at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Wear
- What is being tested?
- Teeth scan with intraoral scanner (Trios, 3 Shape, Denmark)
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 20 Mar 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Study participants will be dental students enrolled in Dental Prosthetics Course I at the beginning of the observation period.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Department of Dental Prosthetics, Dental Division of the University Hospital Carl Gustav Carus at the Technische Universität Dresden
Dresden, Saxony, 01307
Jana Gursinsky, 00493514582706, jana.gursinky@ukdd.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Tooth Wear
- Being tested
- Teeth scan with intraoral scanner (Trios, 3 Shape, Denmark)
- Medical subject headings
- Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teeth scan with intraoral scanner (Trios, 3 Shape, Denmark)Device
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of tooth structure loss and its' progression under stressfull conditons and diverse dietary habits.
Tooth wear will be mesaured in micrometers (µm).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start20 Mar 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Tooth WearStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Passia, Prof. Dr., Study director, Department of Dental Prosthetics, University Hospital at the Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791175
- Sponsor's protocol ID
- DresdenStressDentalStudents
- Acronym
- STSLDS
- Status last verified
- Mar 2023
- First submitted
- 17 Mar 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32810097Al-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.
PubMed 33235511Bartlett 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.
PubMed 18228057Bartlett 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.
PubMed 9524373Elani 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.
PubMed 24489030Kuhn M, Turp JC. Risk factors for bruxism. Swiss Dent J. 2018 Feb 12;128(2):118-124. doi: 10.61872/sdj-2018-02-369.
PubMed 29533049Mangano 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.
PubMed 29233132Marro 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.
PubMed 31834944Mekhemar 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.
PubMed 34356466Milosevic 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.
PubMed 21904350Milosevic 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.
PubMed 36360939Picos 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.
PubMed 30564013Polmann 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.
PubMed 33377534Schlenz 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.
PubMed 34498100Shellis 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.
PubMed 24993256
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Tooth Structure Loss in Dental Students. A Prospective, Longitudinal Pilot - Observational Study.
- ClinicalTrials.gov ID
- NCT05791175
- Acronym / sponsor ID
- STSLDS / DresdenStressDentalStudents
- Conditions
- Tooth Wear
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 20 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study participants will be dental students enrolled in Dental Prosthetics Course I at the beginning of the observation period.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teeth scan with intraoral scanner (Trios, 3 Shape, Denmark)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. | Device | – |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Background: PubMed 32810097Abbasi 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.
- Background: PubMed 33235511Al-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.
- Background: PubMed 18228057Bartlett 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.
- Background: PubMed 9524373Bartlett 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.
- Background: PubMed 24489030Elani 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.
- Background: PubMed 29533049Kuhn M, Turp JC. Risk factors for bruxism. Swiss Dent J. 2018 Feb 12;128(2):118-124. doi: 10.61872/sdj-2018-02-369.
- Background: PubMed 29233132Mangano 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.
- Background: PubMed 31834944Marro 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.
- Background: PubMed 34356466Mekhemar 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.
- Background: PubMed 21904350Milosevic 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.
- Background: PubMed 36360939Milosevic 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.
- Background: PubMed 30564013Picos 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Passia, Prof. Dr. study director
Department of Dental Prosthetics, University Hospital at the Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Wear, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elzbieta Pacek, Dr. (00493514585184, elzbieta.pacek@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of tooth structure loss and its' progression under stressfull conditons and diverse dietary habits. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05791175, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.