Prediction of Tooth WearPREDITOOTHNCT06681844
Predict Tooth Wear
An observational study of Prediction of Tooth Wear, run by Hospices Civils de Lyon at 5 sites in 5 countries.
Trial summary
Tooth wear, resulting from gradual loss of dental hard tissue due to mechanical and chemical factors, impacts tooth structure, texture, and function. It affects quality of life, with varying prevalence (26.9% to 90.0%), and is traditionally detected visually during check-ups, often at advanced stages. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prediction of Tooth Wear
- What is being tested?
- Tooth Shape assessed using an intraoral scanner one after avulsion
- How many people
- 1,000 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 12 Dec 2023to Dec 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Avulsed teeth at the Oral Surgery Departement of the Lyon Dental University Hospital
Who may be able to join
- teeth avulsed presenting a tooth wear index between 0 and 3
- mature incisor, canine, premolar or molars (1st and 2nd only)
Who cannot join
- teeth avulsed presenting a tooth wear index over 3 (or presenting an oral rehabilitation representative of a similar wear)
- immature teeth or teeth without root edification
- wisdom teeth
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Maxime Ducret, Professor contact
5 sites in 5 countries
United States1 site, 1 recruiting
- Recruiting
Indiana University Hospital
Indianapolis, Indiana, 46202
Anderson Hara
Belgium1 site, 1 recruiting
- Recruiting
KU Leuven University Hospital
Leuven
Pierre Lahoud
France1 site, 1 recruiting
- Recruiting
Lyon Dental Hospital
Lyon, 69007
Raphael Richert, PhD, +33669523314, raphael.richert@univ-lyon1.fr
India1 site, 1 recruiting
- Recruiting
King George Medical University
Lucknow
Akhilanand Chaurasia
About this study
Official title: Prediction of the Tooth Wear Index Based on a Dataset of Dental Shapes:a Retrospective Study
Tooth wear, resulting from gradual loss of dental hard tissue due to mechanical and chemical factors, impacts tooth structure, texture, and function. It affects quality of life, with varying prevalence (26.9% to 90.0%), and is traditionally detected visually during check-ups, often at advanced stages. Monitoring alterations in tooth shape via intraoral scanners aids early detection, but restoration remains challenging. Prevention through early detection is vital, as patients may not fully comprehend tooth structure loss until visible. Recently, statistical shape analysis (SSA) used to learn the tooth anatomy and define a reference shape (biogeneric tooth) using. However, assuring landmark consistency is challenging mostly due to biases of the operator. Recently, a robust method called MEG-IsoQuad offered automated, isotopological remeshing. Combining this with SSA holds promise for diagnostic and simulation purposes. This study aims to assess the reliability of a remeshing-SSA approach for altered and intact premolar analysis and compare machine learning algorithms for simulating the shape of the initially intact tooth or future altered one.
The clinical perspective of the current work offers possibilities to:
- Prevent future tooth wear by detecting it at an early stage; and communicate better to the patient by presenting him/her potential future altered teeth
- Simulate the adapted reconstruction for the altered tooth by simulating the initially intact one
- Conditions
- Prediction of Tooth Wear
- Being tested
- Tooth Shape assessed using an intraoral scanner one after avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth Shape assessed using an intraoral scanner one after avulsionOther
- Tooth Shape assessed using an intraoral scanner one after avulsion and stored as StereoLithography (STL) file
- Age, gender, reason of avulsion, type of tooth taken from the database and stored in a google sheet
| Study group | Role | What they receive |
|---|---|---|
| all mature teeth presenting a tooth wear intact or presenting a tooth wear altered | Scaling of the tooth before scanning by the operator Evaluation of the tooh wear index 0 or 1 (by 2 calibrated experts ) Receives: Other: Tooth Shape assessed using an intraoral scanner one after avulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of the tooth wear index based on a dataset of dental shapes:a retrospective study
Four machine learning (ML) algorithms: a linear discriminant analysis (LDA) a support vector machine (SVM), a random forest (RM) and a gradient boosting machine (GBM) will be used to predict the tooth type and the alteration of the anatomy. The data set will be split into a 60/40 train and holdout test data set and models will be three-fold cross validated. Model performances will be evaluated in confusion matrices leading to define precision, recall, F1 score and accuracy.
Measured: only once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start12 Dec 2023
- Primary completion12 Dec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediction of Tooth WearStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681844
- Sponsor's protocol ID
- 69HCL23_1046
- Acronym
- PREDITOOTH
- Status last verified
- Nov 2024
- First submitted
- 10 Nov 2023
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of the Tooth Wear Index Based on a Dataset of Dental Shapes:a Retrospective Study
- ClinicalTrials.gov ID
- NCT06681844
- Acronym / sponsor ID
- PREDITOOTH / 69HCL23_1046
- Conditions
- Prediction of Tooth Wear
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 12 Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Nov 2024 (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.
Tooth wear, resulting from gradual loss of dental hard tissue due to mechanical and chemical factors, impacts tooth structure, texture, and function. It affects quality of life, with varying prevalence (26.9% to 90.0%), and is traditionally detected visually during check-ups, often at advanced stages. Monitoring alterations in tooth shape via intraoral scanners aids early detection, but restoration remains challenging. Prevention through early detection is vital, as patients may not fully comprehend tooth structure loss until visible. Recently, statistical shape analysis (SSA) used to learn the tooth anatomy and define a reference shape (biogeneric tooth) using. However, assuring landmark consistency is challenging mostly due to biases of the operator. Recently, a robust method called MEG-IsoQuad offered automated, isotopological remeshing. Combining this with SSA holds promise for diagnostic and simulation purposes. This study aims to assess the reliability of a remeshing-SSA approach for altered and intact premolar analysis and compare machine learning algorithms for simulating the shape of the initially intact tooth or future altered one.
The clinical perspective of the current work offers possibilities to:
- Prevent future tooth wear by detecting it at an early stage; and communicate better to the patient by presenting him/her potential future altered teeth
- Simulate the adapted reconstruction for the altered tooth by simulating the initially intact one
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all mature teeth presenting a tooth wear intact or presenting a tooth wear altered | – | Other: Tooth Shape assessed using an intraoral scanner one after avulsionScaling of the tooth before scanning by the operator Evaluation of the tooh wear index 0 or 1 (by 2 calibrated experts ) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Avulsed teeth at the Oral Surgery Departement of the Lyon Dental University Hospital
Key inclusion criteria (2 listed)
- teeth avulsed presenting a tooth wear index between 0 and 3
- mature incisor, canine, premolar or molars (1st and 2nd only)
Key exclusion criteria (3 listed)
- teeth avulsed presenting a tooth wear index over 3 (or presenting an oral rehabilitation representative of a similar wear)
- immature teeth or teeth without root edification
- wisdom teeth
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 |
|---|---|---|
| Tooth Shape assessed using an intraoral scanner one after avulsion* Tooth Shape assessed using an intraoral scanner one after avulsion and stored as StereoLithography (STL) file * Age, gender, reason of avulsion, type of tooth taken from the database and stored in a google sheet | Other | all mature teeth presenting a tooth wear intact or presenting a tooth wear altered |
Primary outcome
Prediction of the tooth wear index based on a dataset of dental shapes:a retrospective study
Time frame: only once
Four machine learning (ML) algorithms: a linear discriminant analysis (LDA) a support vector machine (SVM), a random forest (RM) and a gradient boosting machine (GBM) will be used to predict the tooth type and the alteration of the anatomy. The data set will be split into a 60/40 train and holdout test data set and models will be three-fold cross validated. Model performances will be evaluated in confusion matrices leading to define precision, recall, F1 score and accuracy.
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 8 Nov 2024.
- Individual participant dataSharing planned: No
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.
Maxime Ducret, Professor contact
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prediction of Tooth Wear, run by Hospices Civils de Lyon at 5 sites in 5 countries.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Belgium, France, India, Israel. 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 Raphael Richet, Clinical Assistant (+33669523314, raphael.richert@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of the tooth wear index based on a dataset of dental shapes:a retrospective study (time frame: only once). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2024.