<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03780270</url>
  </required_header>
  <id_info>
    <org_study_id>500</org_study_id>
    <nct_id>NCT03780270</nct_id>
  </id_info>
  <brief_title>Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization</brief_title>
  <official_title>Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Dentistry Clinical Center of Kosovo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Dentistry Clinical Center of Kosovo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate&#xD;
&#xD;
        1. the additional therapeutic benefit of Curodont Repair for the treatment early occlusal&#xD;
           carious lesions on permanent teeth in children compared fluoride varnish alone&#xD;
&#xD;
        2. the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride&#xD;
           varnish&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: The purpose of this study is to evaluate&#xD;
&#xD;
        1. the additional therapeutic benefit of Curodont Repair for the treatment early occlusal&#xD;
           carious lesions on permanent teeth in children compared fluoride varnish alone&#xD;
&#xD;
        2. the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride&#xD;
           varnish&#xD;
&#xD;
      Methods: 90 patients with early occlusal lesions (ICDAS-II:2-3) on permanent molars and&#xD;
      pre-molars will be allocated in this randomized, controlled, single blinded study to one of&#xD;
      the two test groups (Test1: Curodont™ Repair+Fluoride Varnish; Test2: Curodont&#xD;
      Repair+Curodont Protect) or control (Fluoride Varnish) group.&#xD;
&#xD;
      Lesions will be assessed at baseline and recalls after 3, 6 and 12 months regarding caries&#xD;
      activity (Nyvad), clinical status (ICDAS-II) and with Diagnodent®. Visual Analog Scale (VAS)&#xD;
      in addition to the Global Impression of Change Questionnaire will also be used for the&#xD;
      evaluation of the outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2014</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group</measure>
    <time_frame>Day 180</time_frame>
    <description>Diagnodent values for fissure caries:&#xD;
0-5: no demineralization, sound. 6-14: outer enamel demineralization. 15-20: inner enamel demineralization. 21-99: dentine demineralization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group</measure>
    <time_frame>Day 90 and Day 360</time_frame>
    <description>Diagnodent values for fissure caries:&#xD;
0-5: no demineralization, sound. 6-14: outer enamel demineralization. 15-20: inner enamel demineralization. 21-99: dentine demineralization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of change in ICDAS-II (International caries detection and assessment system) codes for each study group</measure>
    <time_frame>Day 90, Day 180, Day 360</time_frame>
    <description>Code 0: Sound tooth surface, no evidence of caries after prolonged air drying (5 sec).&#xD;
Code 1: First visual change in enamel. Code 2: Distinct visual change in enamel. Code 3: Localized enamel breakdown due to caries with no visible dentine or underlying shadow.&#xD;
Code 4: Underlying dark shadow from dentine with or without enamel breakdown. Code 5: Distinct cavity with visible dentine. Code 6: Extensive distinct cavity with visible dentine (involving more than half of the dentine).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of change in caries lesion activity and severity assessed by Nyvad criteria for each study group</measure>
    <time_frame>Day 90, Day 180, Day 360</time_frame>
    <description>Score 0: Sound. Score 1: Active caries - intact surface. Score 2: Active caries - surface discontinuity. Score 3: Active caries - cavity. Score 4: Inactive caries - intact surface. Score 5: Inactive caries - surface discontinuity. Score 6: Inactive caries - cavity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean of VAS values (Visual analogue scale) for each study group</measure>
    <time_frame>Day 90, Day 180, Day 360</time_frame>
    <description>Range: from -50 (strongly remineralizing) to +50 (stronlgy progressing)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Evaluation Outcome of Global Impression of Change Questionnaire for each study group</measure>
    <time_frame>Day 90, Day 180, Day 360</time_frame>
    <description>Investigator Questionnaire: evaluation ranging from &quot;very much worse&quot; to &quot;very much better&quot;; 7-point scale</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Tooth Decay</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fluoride Varnish (Fluor Protector S; Ivoclar, 7'700 ppm F-) application at Day 0 and Day180.&#xD;
=&gt; Group: Fluoride Varnish</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single application of Curodont Repair (P11-4) at Day 0 followed by a Fluoride Varnish (Fluor Protector S; Ivoclar, 7'700 ppm F-) application. Another fluoride Varnish application at Day180.&#xD;
=&gt; Group: Curodont Repair + Fluoride Varnish</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single application of Curodont Repair (P11-4) at Day 0. Curodont Protect (tooth gel containing P11-4 matrix) is handed out and subjects are asked to apply it 2x weekly at home after regular teeth cleaning in the evening for the whole study period (Day 360).&#xD;
=&gt; Group: Curodont Repair + Curodont Protect</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fluoride Varnish</intervention_name>
    <description>Fluor Protector S (Ivoclar, 7'700 ppm F-)</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Test1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Curodont Repair</intervention_name>
    <description>P11-4 (monomeric peptide) - for professional use</description>
    <arm_group_label>Test1</arm_group_label>
    <arm_group_label>Test2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Curodont Protect</intervention_name>
    <description>Tooth gel (containing P11-4 assembled to a fibrillary matrix) - for home use (OTC)</description>
    <arm_group_label>Test2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Early occlusal carious lesion which does not require an invasive treatment (ICDAS-II&#xD;
             scores: 2 and 3)&#xD;
&#xD;
          -  Size and form of the lesion: the lesion must both be fully visible and assessable and&#xD;
             accessible&#xD;
&#xD;
          -  Willing and able to attend the on-study visits and to observe good oral hygiene&#xD;
             throughout the study&#xD;
&#xD;
          -  Written informed consent before participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of tooth Erosion&#xD;
&#xD;
          -  Fluoride varnish application &lt; 3 months prior to study treatment&#xD;
&#xD;
          -  History of head and neck illnesses (e.g. head/neck cancer)&#xD;
&#xD;
          -  Any pathology or concomitant medication affecting salivary flow or dry mouth&#xD;
&#xD;
          -  Any metabolic disorders affecting bone turnover&#xD;
&#xD;
          -  Concurrent participation in another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dafina Doberdoli, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Dentistry Clinical Center of Kosovo</affiliation>
  </overall_official>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Clinical Centre of Kosova</investigator_affiliation>
    <investigator_full_name>Dafina Doberdoli</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Fluorides, Topical</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03780270
org study id: 500
nct id: NCT03780270
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate

        1. the additional therapeutic benefit of Curodont Repair for the treatment early occlusal
           carious lesions on permanent teeth in children compared fluoride varnish alone

        2. the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride
           varnish
Objectives: The purpose of this study is to evaluate

        1. the additional therapeutic benefit of Curodont Repair for the treatment early occlusal
           carious lesions on permanent teeth in children compared fluoride varnish alone

        2. the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride
           varnish

      Methods: 90 patients with early occlusal lesions (ICDAS-II:2-3) on permanent molars and
      pre-molars will be allocated in this randomized, controlled, single blinded study to one of
      the two test groups (Test1: Curodont™ Repair+Fluoride Varnish; Test2: Curodont
      Repair+Curodont Protect) or control (Fluoride Varnish) group.

      Lesions will be assessed at baseline and recalls after 3, 6 and 12 months regarding caries
      activity (Nyvad), clinical status (ICDAS-II) and with Diagnodent®. Visual Analog Scale (VAS)
      in addition to the Global Impression of Change Questionnaire will also be used for the
      evaluation of the outcome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group
time frame: Day 180
description: Diagnodent values for fissure caries:
0-5: no demineralization, sound. 6-14: outer enamel demineralization. 15-20: inner enamel demineralization. 21-99: dentine demineralization.
measure: Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group
time frame: Day 90 and Day 360
description: Diagnodent values for fissure caries:
0-5: no demineralization, sound. 6-14: outer enamel demineralization. 15-20: inner enamel demineralization. 21-99: dentine demineralization.
measure: Frequency of change in ICDAS-II (International caries detection and assessment system) codes for each study group
time frame: Day 90, Day 180, Day 360
description: Code 0: Sound tooth surface, no evidence of caries after prolonged air drying (5 sec).
Code 1: First visual change in enamel. Code 2: Distinct visual change in enamel. Code 3: Localized enamel breakdown due to caries with no visible dentine or underlying shadow.
Code 4: Underlying dark shadow from dentine with or without enamel breakdown. Code 5: Distinct cavity with visible dentine. Code 6: Extensive distinct cavity with visible dentine (involving more than half of the dentine).
measure: Frequency of change in caries lesion activity and severity assessed by Nyvad criteria for each study group
time frame: Day 90, Day 180, Day 360
description: Score 0: Sound. Score 1: Active caries - intact surface. Score 2: Active caries - surface discontinuity. Score 3: Active caries - cavity. Score 4: Inactive caries - intact surface. Score 5: Inactive caries - surface discontinuity. Score 6: Inactive caries - cavity.
measure: Mean of VAS values (Visual analogue scale) for each study group
time frame: Day 90, Day 180, Day 360
description: Range: from -50 (strongly remineralizing) to +50 (stronlgy progressing)
measure: Frequency of Evaluation Outcome of Global Impression of Change Questionnaire for each study group
time frame: Day 90, Day 180, Day 360
description: Investigator Questionnaire: evaluation ranging from "very much worse" to "very much better"; 7-point scale
arm group label: Control
arm group type: Active Comparator
description: Fluoride Varnish (Fluor Protector S; Ivoclar, 7'700 ppm F-) application at Day 0 and Day180.
=> Group: Fluoride Varnish
arm group label: Test1
arm group type: Experimental
description: Single application of Curodont Repair (P11-4) at Day 0 followed by a Fluoride Varnish (Fluor Protector S; Ivoclar, 7'700 ppm F-) application. Another fluoride Varnish application at Day180.
=> Group: Curodont Repair + Fluoride Varnish
arm group label: Test2
arm group type: Experimental
description: Single application of Curodont Repair (P11-4) at Day 0. Curodont Protect (tooth gel containing P11-4 matrix) is handed out and subjects are asked to apply it 2x weekly at home after regular teeth cleaning in the evening for the whole study period (Day 360).
=> Group: Curodont Repair + Curodont Protect
intervention type: Device
intervention name: Fluoride Varnish
description: Fluor Protector S (Ivoclar, 7'700 ppm F-)
arm group label: Control
arm group label: Test1
intervention type: Device
intervention name: Curodont Repair
description: P11-4 (monomeric peptide) - for professional use
arm group label: Test1
arm group label: Test2
intervention type: Device
intervention name: Curodont Protect
description: Tooth gel (containing P11-4 assembled to a fibrillary matrix) - for home use (OTC)
arm group label: Test2
criteria: 
gender: All
minimum age: 6 Years
maximum age: 15 Years
healthy volunteers: No
last name: Dafina Doberdoli, Dr.
role: Principal Investigator
affiliation: University Dentistry Clinical Center of Kosovo
responsible party type: Principal Investigator
investigator affiliation: University Clinical Centre of Kosova
investigator full name: Dafina Doberdoli
investigator title: Principal Investigator
mesh term: Dental Caries
mesh term: Fluorides
mesh term: Fluorides, Topical