Trial document




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  DRKS00020123

Trial Description

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Title

Use of the bioluminescence technology to monitor active caries lesions - A clinical study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Background and objective: In addition to the visual control of caries extent and activity, digital procedures can be used for further diagnostic on occlusal surfaces. Recently, an intraoral device has been introduced that uses the so-called bioluminescence technology and can digitally visualize active caries lesions on the occlusal surface of teeth. The aim of this study was to evaluate the correlation between visual assessment and bioluminescence over a time period.

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Brief Summary in Scientific Language

Background and objective: In addition to the visual detection of initial and moderate caries lesions and activity assessement digital technologies can be used to subjectify the findings on occlusal surfaces. Recently, an intraoral device has been introduced that uses the bioluminescence technology in order to digitally visualize active caries lesions on the occlusal surface of teeth. The aim of this study was to evaluate the correlation between visual assessment and bioluminescence measurements and to monitor the findings.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

The study protocol is designed specifically for the location, so there is no relevance to making the study protocol available.

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Organizational Data

  •   DRKS00020123
  •   2019/12/03
  •   [---]*
  •   yes
  •   Approved
  •   156/19, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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Health Condition or Problem studied

  •   K02.0 -  Caries limited to enamel
  •   K02.1 -  Caries of dentine
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Interventions/Observational Groups

  •   Visit 1:
    Baseline: visual diagnosis, single visit in the following order:
    1. Visual assessment of tooth surface (method: ICDAS), one time each patient
    2. if applicable: assessment of radiographs, one time each patient
    3. Treatment decision
    4. Bioluminescence measurements (Calcivis imaging system), one time each patient


    Visit 2:
    Six months after baseline, same participants: visual diagnosis, single visit in the following order:
    1. Visual assessment of tooth surface (method: ICDAS), one time each patient
    2. if applicable: assessment of radiographs, one time each patient
    3. Treatment decision
    4. Bioluminescence measurements (Calcivis imaging system), one time each Patient

    Visit 3:
    Twelve months after baseline, same participants: visual diagnosis, single visit in the following order:
    1. Visual assessment of tooth surface (method: ICDAS), one time each patient
    2. if applicable: assessment of radiographs, one time each patient
    3. Treatment decision
    4. Bioluminescence measurements (Calcivis imaging system), one time each patient
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Primary Outcome: Agreement of visual activity assessement of caries lesions / active lesions in bioluminescence Image

Method: observation. Classification: active lesion caries yes/no

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Secondary Outcome

Ability of the bioluminescence method to monitor caries lesions over time.
Method: observation. Classification: 6 and 12 month after baseline examination

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2020/01/22
  •   12
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Signed, written consent before participation in the study
- Patients who are willing to attend all study-related appointments
- Patients with at least 6 posterior teeth (premolars / molars) without crowns
- Patients with at least one occlusal caries on the (premolars / molars)
- sound occlusal surfaces and occlusal surfaces with initial and moderate lesions

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Exclusion Criteria

- Patients with hypersensitivity or allergy to proteins (no separate allergy testing planned for the study)
- Patients without adequate cooperation during the dental examinations
- Patients who do not follow follow-up appointments
- pregnant women (no separate pregnancy test planned for the study)
- patients with bleached teeth (<2 weeks before measurements)
- Patients with acute toothache
- Patients with crowns on all premolars and molars
- Patients without premolars and molars
- Occlusal surfaces with extensive carious lesions (visible dentin caries)
- teeth with anomalies, tooth fluorosis or hypomineralisation

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Addresses

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    • Philipps-Universität Marburg, Medizinisches Zentrum für ZMK, Abteilung für Kieferorthopädie
    • Ms.  Prof. Dr.  Anahita  Jablonski-Momeni 
    • Georg-Voigt Straße 3
    • 35039  Marburg
    • Germany
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    • Philipps-Universität Marburg, Medizinisches Zentrum für ZMK, Abteilung für Kieferorthopädie
    • Ms.  Prof. Dr.  Anahita  Jablonski-Momeni 
    • Georg-Voigt Straße 3
    • 35039  Marburg
    • Germany
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    • Philipps-Universität Marburg, Medizinisches Zentrum für ZMK, Abteilung für Kieferorthopädie
    • Ms.  Prof. Dr.  Anahita  Jablonski-Momeni 
    • Georg-Voigt Straße 3
    • 35039  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Philipps-Universität Marburg, Medizinisches Zentrum für ZMK, Abteilung für Kieferorthopädie
    • Ms.  Prof. Dr.  Anahita  Jablonski-Momeni 
    • Georg-Voigt Straße 3
    • 35039  Marburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.