DIMOH: New Digital Methods for Monitoring Oral Health. An in Vivo Assessment

NCT04050306 | Unknown

• 1 other identifier: 8053-00005B
• Study Type: observational
• Target: 70
• Locations: 2 countries
• Sites: 2

Brief 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. 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).

Conditions

Dental Caries; Tooth Wear

Keywords

Quantitative Light-Induced Fluorescence; Oral Health; Dental Caries; Tooth Wear; Optical Imaging

Outcome Measures

Primary Outcomes (13)

• 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

• 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), 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).

  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).

  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), 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).

  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).

  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), 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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  Baseline - 12 months

Study Arms (1)

Adolescents and young adults

Participants 12-19 years old without chronic diseases.

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Participants 12-19 years old without chronic diseases

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Copenhagen: lead
• Innovation Fund Denmark: collaborator
• National and Kapodistrian University of Athens: collaborator
• 3Shape A/S: collaborator

Study Sites (2)

Department of Odontology, Faculty of Health and Medical Sciences, Univeristy of Copenhagen

Copenhagen, 2200, Denmark

RECRUITING

School of Dentistry, National and Kapodistrian Univeristy of Athens

Athens, 11527, Greece

COMPLETED

Related Publications (10)

• 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.

  PMID: 28540937 BACKGROUND

• Ganss C, Lussi A. Diagnosis of erosive tooth wear. Monogr Oral Sci. 2014;25:22-31. doi: 10.1159/000359935. Epub 2014 Jun 26.

  PMID: 24993255 BACKGROUND

• 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.

  PMID: 29660487 BACKGROUND

• Pretty 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.

  PMID: 16901606 BACKGROUND

• 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.

  PMID: 23985434 BACKGROUND

• 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.

  PMID: 23146817 BACKGROUND

• 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.

  PMID: 24916677 BACKGROUND

• 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: 18228057 BACKGROUND

• Norrisgaard 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.

  PMID: 26651538 BACKGROUND

• Michou 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.

  PMID: 38412900 DERIVED

MeSH Terms

Conditions

Dental Caries; Tooth Wear

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• STAVROULA MICHOU, DDS

  Department of Odontology, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

STAVROULA MICHOU, DDS

CONTACT

+4531554266; stmi@sund.ku.dk

ANA R. BENETTI, PhD

CONTACT

+4535326800; arbe@sund.ku.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student, Principal Investigator

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 8, 2019
• Study Start: March 27, 2019
• Primary Completion: September 30, 2020
• Study Completion: December 18, 2020
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

GR (1); DK (1)