Dental CariesNCT04050306
DIMOH: New Digital Methods for Monitoring Oral Health. An in Vivo Assessment
An observational study of Dental Caries and Tooth Wear, run by University of Copenhagen at 2 sites in 2 countries.
Trial summary
The objectives of this study are i) to monitor the oral health of young people over a period of one year and ii) to assess the ability of a new intraoral scanner combining fluorescence with 3D imaging to detect and monitor changes in the dental hard tissues in vivo. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Tooth Wear
- How many people
- 70 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Mar 2019to 18 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The participants in this project will be healthy young people 12-19 years old. The adolescents (12-16 years old) will be recruited in Denmark and they will be students from national public schools in the Capital Region of Denmark. The young adults (18-19 years old) will be recruited in Greece and they will be 1st-year University students at the School of Dentistry of the National and Kapodistrian University of Athens.
Who may be able to join
- Participants 12-19 years old without chronic diseases
Who cannot join
- Participants in need of complex dental treatment (e.g. extensive restorative work, extractions, prosthetic treatment).
- Participants using partial/complete removable dentures or other appliances (i.e. orthodontic).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Denmark1 site, 1 recruiting
- Recruiting
Department of Odontology, Faculty of Health and Medical Sciences, Univeristy of Copenhagen
Copenhagen, 2200
Stavroula Michou, DDS, +4531554266, stmi@sund.ku.dk
Ana R. Benetti, PhD, +4535326800, arbe@sund.ku.dk
Greece1 site
- Completed
School of Dentistry, National and Kapodistrian Univeristy of Athens
Athens, 11527
About this study
The objectives of this study are i) to monitor the oral health of young people over a period of one year and ii) to assess the ability of a new intraoral scanner combining fluorescence with 3D imaging to detect and monitor changes in the dental hard tissues in vivo.
The working hypotheses of this study are that i) the monitoring of oral health will benefit from using a new intraoral scanner combining fluorescence with 3D imaging and ii) the new intraoral scanner combining fluorescence with 3D imaging will aid dentists to identify changes in the dental hard tissues at earlier stages than the traditional diagnostic methods (i.e. visual-tactile, radiographic methods).
Read the detailed description
Currently, monitoring oral health relies mainly on the visual examination of the oral tissues aided electively by radiographic or photographic images. In the context of oral health, monitoring involves detecting changes, sometimes rather subtle, in the soft or hard oral tissues.
The slow rate of change involved in some situations, like loss of mineral tissues due to caries or tooth wear, makes it extremely difficult for the human eye alone to identify them. It is even more challenging to accurately register and recall the original situation on the patient's follow-up visits. Clinical photographs are therefore used to aid the monitoring however, it is difficult to obtain comparable photographs from different points in time and the subjectivity involved in the process cannot be avoided.
Different criteria are used in clinical practice to register and monitor changes in the oral tissues, according to the specific condition under investigation. While identifying significant changes is an easy task, the challenge lies particularly in identifying early, incremental changes. Regarding the detection of caries lesions, a number of initial lesions typically remain unnoticed when visual examination alone is used; or even when radiographs are employed, as the latter are not sensitive to early demineralization in enamel. Concerning tooth wear (i.e. erosion, abrasion, attrition), as the gradual mineral loss occurs progressively and irreversibly, it is usually only noticed when a significant amount of hard dental tissue is already lost.
A promising clinical solution to overcome the challenges involved in the detection of early changes and monitoring of oral tissues is the use of 3D intraoral scans. Obtaining 3D scans directly from the patients (in vivo) using intraoral scanners and by comparing 3D scans obtained from the same patients at different points in time, a less subjective and more reliable comparison of data is expected: the 3D scans can be overlapped and analyzed using specific software. Therefore, it is hypothesized that 3D intraoral scans can be used for more consistent monitoring of oral health in relation to clinical photographs or clinical records.
The current 3D intraoral scanners capture the color of the oral tissues by emitting visible white light. A recently developed 3D intraoral scanner manufactured by 3Shape A/S, Denmark, is also able to emit visible blue light (415 nm wavelength) that allows capturing fluorescence from the oral tissues. Fluorescence is one of the most promising technologies for accurate detection of the early stages of enamel demineralization, but is currently available only in 1D or 2D devices. The main limitation of the existing devices featuring fluorescence, as already mentioned, is the challenge in comparing single images obtained at different points in time, which is at large influenced by imaging artifacts and noise. Imprecision in the comparison of these images compromises the ability to accurately monitor progressive demineralization of the dental hard tissues. There is no intraoral scanner reported in the scientific literature that combines fluorescence with 3D imaging. Thus, the investigators hypothesize that this new intraoral scanner will benefit the monitoring of dental hard tissues and will aid dentists to identify early changes in tissue mineralization. With this method it is only possible to examine the tooth surfaces that are visible and directly exposed into the mouth (i.e. the smooth free surfaces and the occlusal fissures); the areas between the teeth (i.e. the approximal surfaces) cannot be visualized and therefore cannot be examined using the scanner.
A total number of 70 participants will be recruited for the study, including adolescents and young adults (12-19 years old). The oral health of all participants will be examined using visual-tactile and radiographic methods. Subsequently, both the upper and lower jaw of the participants will be scanned using the intraoral scanner (TRIOS 4, 3Shape TRIOS A/S, Denmark). All participants will be monitored for 1 year with follow-up intervals of 3 to 12 months according to the risk group that they are classified into (low, moderate, high). The same clinical procedures will be followed on the follow-up examinations (3 or 6 months) as well as on the final examination (1-year follow-up) The clinical registrations from oral examination using the state-of-the-art methods (visual-tactile, radiographic) will be compared with the outcomes from the assessment using the intraoral scanner.
- Conditions
- Dental Caries, Tooth Wear
- Keywords
- Quantitative Light-Induced Fluorescence, Oral Health, Dental Caries, Tooth Wear, Optical Imaging
- Medical subject headings
- Dental Caries, Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents and young adults | Participants 12-19 years old without chronic diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1st Clinical caries score
Caries score registered by conducting the traditional clinical (visual-tactile) and radiographic examination.
The International Caries Detection and Assessment System (ICDAS) codes will be used. Scale ranges from 0 (sound surfaces) to 6 (extensive cavitated caries lesions located into the inner third of the dentin).
Measured: Baseline
1st Scanner caries score
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score.
Scale used:
0 (sound surfaces),
- (initial caries lesions in enamel or into the outer third of dentin),
- (moderate - extensive caries lesions located into the middle - inner third of dentin).
Measured: Baseline
2nd Clinical caries score
Caries score registered by conducting the traditional clinical (visual-tactile) and radiographic examination.
The International Caries Detection and Assessment System (ICDAS) codes will be used.
Scale ranges from 0 (sound surfaces) to 6 (extensive cavitated caries lesions located into the inner third of the dentin).
Measured: 3 or 6 months after the baseline examination dependent on the risk of the patient (i.e. 3 months for high risk, 6 months for moderate risk, NO 2nd clinical caries score for low risk)
2nd Scanner caries score
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score.
Scale used:
0 (sound surfaces),
- (initial caries lesions in enamel or into the outer third of dentin),
- (moderate - extensive caries lesions located into the middle - inner third of dentin).
Measured: 3 or 6 months after the baseline examination dependent on the caries risk of the patient (i.e. 3 months for high risk, 6 months for moderate risk, NO 2nd score for low risk)
3rd Clinical caries score
Caries score registered by conducting the traditional clinical (visual-tactile) and radiographic examination.
The International Caries Detection and Assessment System (ICDAS) codes will be used.
Scale ranges from 0 (sound surfaces) to 6 (extensive cavitated caries lesions located into the inner third of the dentin).
Measured: 12 months after the baseline examination
3rd Scanner caries score
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score.
Scale used:
0 (sound surfaces),
- (initial caries lesions in enamel or into the outer third of dentin),
- (moderate - extensive caries lesions located into the middle - inner third of dentin).
Measured: 12 months after the baseline examination
1st Tooth wear scan score
Tooth wear score is registered by visually examining the 3D scans of the participants and applying the Basic Erosive Wear Examination (BEWE) index.
Scale ranges from 0 (No surface loss) to 3 (Distinct defect, hard tissue loss of more than 50% of the surface area).
Measured: Baseline
1st Clinical tooth wear score
Tooth wear score is registered by examining the participants clinically and applying the Basic Erosive Wear Examination (BEWE) index.
Scale ranges from 0 (No surface loss) to 3 (Distinct defect, hard tissue loss of more than 50% of the surface area).
Measured: Baseline
2nd Tooth wear scan score
Tooth wear score is registered by visually examining the 3D scans of the participants and applying the Basic Erosive Wear Examination (BEWE) index.
Scale ranges from 0 (No surface loss) to 3 (Distinct defect, hard tissue loss of more than 50% of the surface area).
Measured: 3 or 6 months after the baseline examination dependent on the risk of the patient (i.e. 3 months for high risk, 6 months for moderate risk, NO 2nd score for low risk)
2nd Clinical tooth wear score
Tooth wear score is registered by examining the participants clinically and applying the Basic Erosive Wear Examination (BEWE) index.
Scale ranges from 0 (No surface loss) to 3 (Distinct defect, hard tissue loss of more than 50% of the surface area).
Measured: 3 or 6 months after the baseline examination dependent on the risk of the patient (i.e. 3 months for high risk, 6 months for moderate risk, NO 2nd score for low risk)
3rd Tooth wear scan score
Tooth wear score is registered by visually examining the 3D scans of the participants and applying the Basic Erosive Wear Examination (BEWE) index.
Scale ranges from 0 (No surface loss) to 3 (Distinct defect, hard tissue loss of more than 50% of the surface area).
Measured: 12 months after the baseline examination
3rd clinical tooth wear score
Tooth wear score is registered by examining the participants clinically and applying the Basic Erosive Wear Examination (BEWE) index.
Scale ranges from 0 (No surface loss) to 3 (Distinct defect, hard tissue loss of more than 50% of the surface area).
Measured: 12 months after the baseline examination
Tooth surface change due to tooth wear at 12 months
The 3D models of the same participants at two different points in time (baseline and 12-month follow-up examination) will be supperimposed and possible tooth surface differences between the 2 models will be quantified using specific software (Trios Patient Monitoring, 3Shape TRIOS A/S, Denmark).
The maximum difference value per tooth will be registered in mm (measurement error 0.05 mm).
Measured: Baseline - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start27 Mar 2019
- Primary completion30 Sep 2020 (estimated)
- Study completion18 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund Denmark, National and Kapodistrian University of Athens, 3Shape A/S
- Responsible party
- Principal investigator, Stavroula Michou, University of Copenhagen
- Investigators
- STAVROULA MICHOU, DDS, Principal investigator, Department of Odontology, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050306
- Sponsor's protocol ID
- 8053-00005B
- Status last verified
- Aug 2019
- First submitted
- 5 Aug 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pitts NB, Zero DT, Marsh PD, Ekstrand K, Weintraub JA, Ramos-Gomez F, Tagami J, Twetman S, Tsakos G, Ismail A. Dental caries. Nat Rev Dis Primers. 2017 May 25;3:17030. doi: 10.1038/nrdp.2017.30.
PubMed 28540937Ganss C, Lussi A. Diagnosis of erosive tooth wear. Monogr Oral Sci. 2014;25:22-31. doi: 10.1159/000359935. Epub 2014 Jun 26.
PubMed 24993255Marro F, De Lat L, Martens L, Jacquet W, Bottenberg P. Monitoring the progression of erosive tooth wear (ETW) using BEWE index in casts and their 3D images: A retrospective longitudinal study. J Dent. 2018 Jun;73:70-75. doi: 10.1016/j.jdent.2018.04.008. Epub 2018 Apr 13.
PubMed 29660487Pretty IA. Caries detection and diagnosis: novel technologies. J Dent. 2006 Nov;34(10):727-39. doi: 10.1016/j.jdent.2006.06.001. Epub 2006 Aug 9.
PubMed 16901606Pretty IA, Ellwood RP. The caries continuum: opportunities to detect, treat and monitor the re-mineralization of early caries lesions. J Dent. 2013 Aug;41 Suppl 2:S12-21. doi: 10.1016/j.jdent.2010.04.003.
PubMed 23985434Gomez J, Zakian C, Salsone S, Pinto SC, Taylor A, Pretty IA, Ellwood R. In vitro performance of different methods in detecting occlusal caries lesions. J Dent. 2013 Feb;41(2):180-6. doi: 10.1016/j.jdent.2012.11.003. Epub 2012 Nov 9.
PubMed 23146817Pitts NB, Ekstrand KR; ICDAS Foundation. International Caries Detection and Assessment System (ICDAS) and its International Caries Classification and Management System (ICCMS) - methods for staging of the caries process and enabling dentists to manage caries. Community Dent Oral Epidemiol. 2013 Feb;41(1):e41-52. doi: 10.1111/cdoe.12025.
PubMed 24916677Bartlett 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 18228057Norrisgaard PE, Qvist V, Ekstrand K. Prevalence, risk surfaces and inter-municipality variations in caries experience in Danish children and adolescents in 2012. Acta Odontol Scand. 2016;74(4):291-7. doi: 10.3109/00016357.2015.1119306. Epub 2015 Dec 14.
PubMed 26651538Michou S, Tsakanikou A, Bakhshandeh A, Ekstrand KR, Rahiotis C, Benetti AR. Occlusal caries detection and monitoring using a 3D intraoral scanner system. An in vivo assessment. J Dent. 2024 Apr;143:104900. doi: 10.1016/j.jdent.2024.104900. Epub 2024 Feb 25.
PubMed 38412900
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIMOH: New Digital Methods for Monitoring Oral Health. An in Vivo Assessment
- ClinicalTrials.gov ID
- NCT04050306
- Acronym / sponsor ID
- 8053-00005B
- Conditions
- Dental Caries, Tooth Wear
- Keywords
- Quantitative Light-Induced Fluorescence, Oral Health, Dental Caries, Tooth Wear, Optical Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark, National and Kapodistrian University of Athens, 3Shape A/S
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 18 Dec 2020 (estimated)
- First posted
- 8 Aug 2019 (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 objectives of this study are i) to monitor the oral health of young people over a period of one year and ii) to assess the ability of a new intraoral scanner combining fluorescence with 3D imaging to detect and monitor changes in the dental hard tissues in vivo.
The working hypotheses of this study are that i) the monitoring of oral health will benefit from using a new intraoral scanner combining fluorescence with 3D imaging and ii) the new intraoral scanner combining fluorescence with 3D imaging will aid dentists to identify changes in the dental hard tissues at earlier stages than the traditional diagnostic methods (i.e. visual-tactile, radiographic methods).
Detailed description
Currently, monitoring oral health relies mainly on the visual examination of the oral tissues aided electively by radiographic or photographic images. In the context of oral health, monitoring involves detecting changes, sometimes rather subtle, in the soft or hard oral tissues.
The slow rate of change involved in some situations, like loss of mineral tissues due to caries or tooth wear, makes it extremely difficult for the human eye alone to identify them. It is even more challenging to accurately register and recall the original situation on the patient's follow-up visits. Clinical photographs are therefore used to aid the monitoring however, it is difficult to obtain comparable photographs from different points in time and the subjectivity involved in the process cannot be avoided.
Different criteria are used in clinical practice to register and monitor changes in the oral tissues, according to the specific condition under investigation. While identifying significant changes is an easy task, the challenge lies particularly in identifying early, incremental changes. Regarding the detection of caries lesions, a number of initial lesions typically remain unnoticed when visual examination alone is used; or even when radiographs are employed, as the latter are not sensitive to early demineralization in enamel. Concerning tooth wear (i.e. erosion, abrasion, attrition), as the gradual mineral loss occurs progressively and irreversibly, it is usually only noticed when a significant amount of hard dental tissue is already lost.
A promising clinical solution to overcome the challenges involved in the detection of early changes and monitoring of oral tissues is the use of 3D intraoral scans. Obtaining 3D scans directly from the patients (in vivo) using intraoral scanners and by comparing 3D scans obtained from the same patients at different points in time, a less subjective and more reliable comparison of data is expected: the 3D scans can be overlapped and analyzed using specific software. Therefore, it is hypothesized that 3D intraoral scans can be used for more consistent monitoring of oral health in relation to clinical photographs or clinical records.
The current 3D intraoral scanners capture the color of the oral tissues by emitting visible white light. A recently developed 3D intraoral scanner manufactured by 3Shape A/S, Denmark, is also able to emit visible blue light (415 nm wavelength) that allows capturing fluorescence from the oral tissues. Fluorescence is one of the most promising technologies for accurate detection of the early stages of enamel demineralization, but is currently available only in 1D or 2D devices. The main limitation of the existing devices featuring fluorescence, as already mentioned, is the challenge in comparing single images obtained at different points in time, which is at large influenced by imaging artifacts and noise. Imprecision in the comparison of these images compromises the ability to accurately monitor progressive demineralization of the dental hard tissues. There is no intraoral scanner reported in the scientific literature that combines fluorescence with 3D imaging. Thus, the investigators hypothesize that this new intraoral scanner will benefit the monitoring of dental hard tissues and will aid dentists to identify early changes in tissue mineralization. With this method it is only possible to examine the tooth surfaces that are visible and directly exposed into the mouth (i.e. the smooth free surfaces and the occlusal fissures); the areas between the teeth (i.e. the approximal surfaces) cannot be visualized and therefore cannot be examined using the scanner.
A total number of 70 participants will be recruited for the study, including adolescents and young adults (12-19 years old). The oral health of all participants will be examined using visual-tactile and radiographic methods. Subsequently, both the upper and lower jaw of the participants will be scanned using the intraoral scanner (TRIOS 4, 3Shape TRIOS A/S, Denmark). All participants will be monitored for 1 year with follow-up intervals of 3 to 12 months according to the risk group that they are classified into (low, moderate, high). The same clinical procedures will be followed on the follow-up examinations (3 or 6 months) as well as on the final examination (1-year follow-up) The clinical registrations from oral examination using the state-of-the-art methods (visual-tactile, radiographic) will be compared with the outcomes from the assessment using the intraoral scanner.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents and young adults | – | –Participants 12-19 years old without chronic diseases. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The participants in this project will be healthy young people 12-19 years old. The adolescents (12-16 years old) will be recruited in Denmark and they will be students from national public schools in the Capital Region of Denmark. The young adults (18-19 years old) will be recruited in Greece and they will be 1st-year University students at the School of Dentistry of the National and Kapodistrian University of Athens.
Key inclusion criteria (1 listed)
- Participants 12-19 years old without chronic diseases
Key exclusion criteria (2 listed)
- Participants in need of complex dental treatment (e.g. extensive restorative work, extractions, prosthetic treatment).
- Participants using partial/complete removable dentures or other appliances (i.e. orthodontic).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1st Clinical caries score
Time frame: Baseline
Caries score registered by conducting the traditional clinical (visual-tactile) and radiographic examination. The International Caries Detection and Assessment System (ICDAS) codes will be used. Scale ranges from 0 (sound surfaces) to 6 (extensive cavitated caries lesions located into the inner third of the dentin).
1st Scanner caries score
Time frame: Baseline
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
2nd Clinical caries score
Time frame: 3 or 6 months after the baseline examination dependent on the risk of the patient (i.e. 3 months for high risk, 6 months for moderate risk, NO 2nd clinical caries score for low risk)
Caries score registered by conducting the traditional clinical (visual-tactile) and radiographic examination. The International Caries Detection and Assessment System (ICDAS) codes will be used. Scale ranges from 0 (sound surfaces) to 6 (extensive cavitated caries lesions located into the inner third of the dentin).
2nd Scanner caries score
Time frame: 3 or 6 months after the baseline examination dependent on the caries risk of the patient (i.e. 3 months for high risk, 6 months for moderate risk, NO 2nd score for low risk)
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
3rd Clinical caries score
Time frame: 12 months after the baseline examination
Caries score registered by conducting the traditional clinical (visual-tactile) and radiographic examination. The International Caries Detection and Assessment System (ICDAS) codes will be used. Scale ranges from 0 (sound surfaces) to 6 (extensive cavitated caries lesions located into the inner third of the dentin).
3rd Scanner caries score
Time frame: 12 months after the baseline examination
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
1st Tooth wear scan score
Time frame: Baseline
Tooth wear score is registered by visually examining the 3D scans of the participants and applying the Basic Erosive Wear Examination (BEWE) index. Scale ranges from 0 (No surface loss) to 3 (Distinct defect, hard tissue loss of more than 50% of the surface area).
1st Clinical tooth wear score
Time frame: Baseline
Tooth wear score is registered by examining the participants clinically and applying the Basic Erosive Wear Examination (BEWE) index. Scale ranges from 0 (No surface loss) to 3 (Distinct defect, hard tissue loss of more than 50% of the surface area).
2nd Tooth wear scan score
Time frame: 3 or 6 months after the baseline examination dependent on the risk of the patient (i.e. 3 months for high risk, 6 months for moderate risk, NO 2nd score for low risk)
Tooth wear score is registered by visually examining the 3D scans of the participants and applying the Basic Erosive Wear Examination (BEWE) index. Scale ranges from 0 (No surface loss) to 3 (Distinct defect, hard tissue loss of more than 50% of the surface area).
2nd Clinical tooth wear score
Time frame: 3 or 6 months after the baseline examination dependent on the risk of the patient (i.e. 3 months for high risk, 6 months for moderate risk, NO 2nd score for low risk)
Tooth wear score is registered by examining the participants clinically and applying the Basic Erosive Wear Examination (BEWE) index. Scale ranges from 0 (No surface loss) to 3 (Distinct defect, hard tissue loss of more than 50% of the surface area).
3rd Tooth wear scan score
Time frame: 12 months after the baseline examination
Tooth wear score is registered by visually examining the 3D scans of the participants and applying the Basic Erosive Wear Examination (BEWE) index. Scale ranges from 0 (No surface loss) to 3 (Distinct defect, hard tissue loss of more than 50% of the surface area).
3rd clinical tooth wear score
Time frame: 12 months after the baseline examination
Tooth wear score is registered by examining the participants clinically and applying the Basic Erosive Wear Examination (BEWE) index. Scale ranges from 0 (No surface loss) to 3 (Distinct defect, hard tissue loss of more than 50% of the surface area).
Tooth surface change due to tooth wear at 12 months
Time frame: Baseline - 12 months
The 3D models of the same participants at two different points in time (baseline and 12-month follow-up examination) will be supperimposed and possible tooth surface differences between the 2 models will be quantified using specific software (Trios Patient Monitoring, 3Shape TRIOS A/S, Denmark). The maximum difference value per tooth will be registered in mm (measurement error 0.05 mm).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Background: PubMed 28540937Pitts NB, Zero DT, Marsh PD, Ekstrand K, Weintraub JA, Ramos-Gomez F, Tagami J, Twetman S, Tsakos G, Ismail A. Dental caries. Nat Rev Dis Primers. 2017 May 25;3:17030. doi: 10.1038/nrdp.2017.30.
- Background: PubMed 24993255Ganss C, Lussi A. Diagnosis of erosive tooth wear. Monogr Oral Sci. 2014;25:22-31. doi: 10.1159/000359935. Epub 2014 Jun 26.
- Background: PubMed 29660487Marro F, De Lat L, Martens L, Jacquet W, Bottenberg P. Monitoring the progression of erosive tooth wear (ETW) using BEWE index in casts and their 3D images: A retrospective longitudinal study. J Dent. 2018 Jun;73:70-75. doi: 10.1016/j.jdent.2018.04.008. Epub 2018 Apr 13.
- Background: PubMed 16901606Pretty IA. Caries detection and diagnosis: novel technologies. J Dent. 2006 Nov;34(10):727-39. doi: 10.1016/j.jdent.2006.06.001. Epub 2006 Aug 9.
- Background: PubMed 23985434Pretty IA, Ellwood RP. The caries continuum: opportunities to detect, treat and monitor the re-mineralization of early caries lesions. J Dent. 2013 Aug;41 Suppl 2:S12-21. doi: 10.1016/j.jdent.2010.04.003.
- Background: PubMed 23146817Gomez J, Zakian C, Salsone S, Pinto SC, Taylor A, Pretty IA, Ellwood R. In vitro performance of different methods in detecting occlusal caries lesions. J Dent. 2013 Feb;41(2):180-6. doi: 10.1016/j.jdent.2012.11.003. Epub 2012 Nov 9.
- Background: PubMed 24916677Pitts NB, Ekstrand KR; ICDAS Foundation. International Caries Detection and Assessment System (ICDAS) and its International Caries Classification and Management System (ICCMS) - methods for staging of the caries process and enabling dentists to manage caries. Community Dent Oral Epidemiol. 2013 Feb;41(1):e41-52. doi: 10.1111/cdoe.12025.
- 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 26651538Norrisgaard PE, Qvist V, Ekstrand K. Prevalence, risk surfaces and inter-municipality variations in caries experience in Danish children and adolescents in 2012. Acta Odontol Scand. 2016;74(4):291-7. doi: 10.3109/00016357.2015.1119306. Epub 2015 Dec 14.
- Derived from this study: PubMed 38412900Michou S, Tsakanikou A, Bakhshandeh A, Ekstrand KR, Rahiotis C, Benetti AR. Occlusal caries detection and monitoring using a 3D intraoral scanner system. An in vivo assessment. J Dent. 2024 Apr;143:104900. doi: 10.1016/j.jdent.2024.104900. Epub 2024 Feb 25.
- 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. This study is not recruiting at the moment.
STAVROULA MICHOU, DDS principal investigator
Department of Odontology, University of Copenhagen
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries and Tooth Wear, run by University of Copenhagen at 2 sites in 2 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact STAVROULA MICHOU, DDS (+4531554266, stmi@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1st Clinical caries score (time frame: Baseline). The study lists 13 primary outcomes in all. 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 NCT04050306, which also lists 10 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 15 Aug 2019.