Dental Caries Clinical Trial
Official title:
DIMOH: New Digital Methods for Monitoring Oral Health. An in Vivo Assessment
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).
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 18, 2020 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 19 Years |
Eligibility |
Inclusion Criteria: - Participants 12-19 years old without chronic diseases Exclusion Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Odontology, Faculty of Health and Medical Sciences, Univeristy of Copenhagen | Copenhagen | |
Greece | School of Dentistry, National and Kapodistrian Univeristy of Athens | Athens |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen | 3Shape A/S, Innovation Fund Denmark, National and Kapodistrian University of Athens |
Denmark, Greece,
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:S65-8. doi: 10.1007/s00784-007-0181-5. Epub 2008 Jan 29. — View Citation
Ganss C, Lussi A. Diagnosis of erosive tooth wear. Monogr Oral Sci. 2014;25:22-31. doi: 10.1159/000359935. Epub 2014 Jun 26. Review. — View Citation
Gomez 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. — View Citation
Marro 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. — View Citation
Nørrisgaard 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. — View Citation
Pitts 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. Review. — View Citation
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. Review. — View Citation
Pretty 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. Review. — View Citation
Pretty IA. Caries detection and diagnosis: novel technologies. J Dent. 2006 Nov;34(10):727-39. Epub 2006 Aug 9. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). |
Baseline | |
Primary | 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). |
Baseline | |
Primary | 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). |
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) | |
Primary | 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). |
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) | |
Primary | 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). |
12 months after the baseline examination | |
Primary | 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). |
12 months after the baseline examination | |
Primary | 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). |
Baseline | |
Primary | 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). |
Baseline | |
Primary | 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). |
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) | |
Primary | 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). |
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) | |
Primary | 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). |
12 months after the baseline examination | |
Primary | 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). |
12 months after the baseline examination | |
Primary | 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). |
Baseline - 12 months |
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