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

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ClinicalTrials.gov Identifier: NCT04050306
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : August 15, 2019
Sponsor:
Collaborators:
Innovation Fund Denmark
National and Kapodistrian University of Athens
3Shape A/S
Information provided by (Responsible Party):
Stavroula Michou, University of Copenhagen

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).


Condition or disease
Dental Caries Tooth Wear

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DIMOH: New Digital Methods for Monitoring Oral Health. An in Vivo Assessment
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Group/Cohort
Adolescents and young adults
Participants 12-19 years old without chronic diseases.



Primary Outcome Measures :
  1. 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).


  2. 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).

  3. 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).


  4. 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).

  5. 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).


  6. 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).

  7. 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).


  8. 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).


  9. 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).


  10. 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).


  11. 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).


  12. 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).


  13. 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).




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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050306


Contacts
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Contact: STAVROULA MICHOU, DDS +4531554266 stmi@sund.ku.dk
Contact: ANA R. BENETTI, PhD +4535326800 arbe@sund.ku.dk

Locations
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Denmark
Department of Odontology, Faculty of Health and Medical Sciences, Univeristy of Copenhagen Recruiting
Copenhagen, Denmark, 2200
Contact: Stavroula Michou, DDS    +4531554266    stmi@sund.ku.dk   
Contact: Ana R. Benetti, PhD    +4535326800    arbe@sund.ku.dk   
Greece
School of Dentistry, National and Kapodistrian Univeristy of Athens Completed
Athens, Greece, 11527
Sponsors and Collaborators
University of Copenhagen
Innovation Fund Denmark
National and Kapodistrian University of Athens
3Shape A/S
Investigators
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Principal Investigator: STAVROULA MICHOU, DDS Department of Odontology, University of Copenhagen
  Study Documents (Full-Text)

Documents provided by Stavroula Michou, University of Copenhagen:

Publications:

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Responsible Party: Stavroula Michou, PhD Student, Principal Investigator, University of Copenhagen
ClinicalTrials.gov Identifier: NCT04050306     History of Changes
Other Study ID Numbers: 8053-00005B
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stavroula Michou, University of Copenhagen:
Quantitative Light-Induced Fluorescence
Oral Health
Dental Caries
Tooth Wear
Optical Imaging

Additional relevant MeSH terms:
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Dental Caries
Tooth Wear
Tooth Attrition
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases