<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/NCT04444154</url>
  </required_header>
  <id_info>
    <org_study_id>35RC20_8945_MAHO</org_study_id>
    <nct_id>NCT04444154</nct_id>
  </id_info>
  <brief_title>Comparison of the Effectiveness of Three Teaching Methods in Oral Hygiene in Adolescent Orthodontic Patients</brief_title>
  <acronym>MAHO</acronym>
  <official_title>Comparison of the Effectiveness of 3 Teaching Methods in Oral Hygiene in Adolescent Orthodontic Patients: Prospective Randomized Controlled Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      Orthodontic appliances have been shown to interfere with oral hygiene maneuvers by providing&#xD;
      many additional sites for formation and retention of biofilm.&#xD;
&#xD;
      Its accumulation is responsible for undesirable effects such as decays and periodontal&#xD;
      pathologies. These lower the benefit / risk ratio of orthodontic treatments. In addition,&#xD;
      their management is not negligible at the macroeconomic level.&#xD;
&#xD;
      As such, it is more than necessary for the orthodontist to teach oral hygiene methods adapted&#xD;
      to each of his patients fitted to limit the risk of appearance of biofilm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients applying for orthodontic treatment with braces in the orthodontic unit of the Rennes&#xD;
      dental center will be offered to participate in the study. For each patient, the inclusion&#xD;
      and non-inclusion criteria will be checked, and consent and a document explaining the course&#xD;
      of the study will be delivered to them personally. The duration of the study will be 6 months&#xD;
      for each of them. Each will be randomized to one of three study groups. Throughout the study,&#xD;
      patients in groups 1 and 2 will have to make 5 appointments. Group 3 patients must honor 6&#xD;
      appointments.&#xD;
&#xD;
      Patients in group 1 (control group) will receive oral hygiene advice given orally in the&#xD;
      chair during the bonding appointment and at each check-up appointment. Patients in group 2&#xD;
      will receive these same oral advice, associated with a demonstration of brushing methods in&#xD;
      the sink with active participation (use of plate developer and then the Oral B electric&#xD;
      toothbrush with special orthodontic head) during the bonding appointment as well than at each&#xD;
      check-up appointment. Patients in group 3 will receive the same treatment as those in group 1&#xD;
      but will have an additional appointment between the device bonding appointment and the first&#xD;
      check-up. This is a 15-minute session dedicated to teaching oral hygiene. This session will&#xD;
      include watching of an educational video followed by a quiz, as well as the application of&#xD;
      the methods taught in the sink (using plate developer and the Oral B electric toothbrush with&#xD;
      special orthodontic head).&#xD;
&#xD;
      At the end of the appliance bonding appointment (first appointment) each patient (from each&#xD;
      group) will leave with a hygiene kit including an electric toothbrush with two orthodontic&#xD;
      heads, an Oral B toothpaste, from orthodontic wax and the analgesic prescription&#xD;
      conventionally performed when installing a device.&#xD;
&#xD;
      The plaque index readings, i.e. the taking of 3 macrophotographic shots (with reflex camera,&#xD;
      allowing the MOP plaque index to be assessed in a second step), and the clinical index of&#xD;
      gingival inflammation will be performed at each appointment (except during the dedicated&#xD;
      session of group 3) by an examiner who will be blind from the group belonging to each&#xD;
      patient.&#xD;
&#xD;
      Exception made for the day of bonding, during which the plate index reading will be made just&#xD;
      before the placement of the multi fasteners via the Loë and Silness plate index (which is an&#xD;
      index adapted to patients not fitted).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 29, 2022</start_date>
  <completion_date type="Anticipated">January 29, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 29, 2025</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>
    <intervention_model_description>prospective, monocentric, controlled, randomized study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The plaque index readings, i.e. the taking of 3 macrophotographic shots (with reflex camera, allowing the MOP plaque index to be assessed in a second step), and the clinical index of gingival inflammation will be performed at each appointment (except during the dedicated session of group 3) by an examiner who will be blind from the group belonging to each patient</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Compare the effectiveness of 3 methods of teaching oral hygiene in terms of controlling biofilm formation: MOP (Modified Orthodnotic Plaque Index) classification</measure>
    <time_frame>6 months of intervention</time_frame>
    <description>The average plaque index at six months after inclusion according to the MOP (Modified Orthodnotic Plaque Index) classification. It is evaluated on macro photography in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare the effectiveness of three teaching methods in oral hygiene for the control of gum inflammation: gingival index at six months after inclusion according to the Loë and Silness scale</measure>
    <time_frame>6 months after bonding the device.</time_frame>
    <description>The mean gingival index at six months after inclusion according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index</measure>
    <time_frame>J0 (during the installation of the device)</time_frame>
    <description>The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The first is the MOP classification plate index. It is evaluated on macrophotographs in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale</measure>
    <time_frame>J0 (during the installation of the device)</time_frame>
    <description>The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The second is the gingival index according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index</measure>
    <time_frame>at 1½ months after installation of the device</time_frame>
    <description>The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The first is the MOP classification plate index. It is evaluated on macrophotographs in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale</measure>
    <time_frame>at 1½ months after installation of the device</time_frame>
    <description>The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The second is the gingival index according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index</measure>
    <time_frame>at 3 months after installation of the device</time_frame>
    <description>The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The first is the MOP classification plate index. It is evaluated on macrophotographs in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale</measure>
    <time_frame>at 3 months after installation of the device</time_frame>
    <description>The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The second is the gingival index according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index</measure>
    <time_frame>at 4½ months after installation of the device</time_frame>
    <description>The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The first is the MOP classification plate index. It is evaluated on macrophotographs in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale</measure>
    <time_frame>at 4½ months after installation of the device</time_frame>
    <description>The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The second is the gingival index according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Orthodontic Appliance</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>oral hygiene advice given orally</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group with active participation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>oral hygiene advice given orally and demonstration of brushing methods in the sink with active participation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group with video and quizz</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral hygiene advice given orally and an additional appointment between the device bonding appointment and the first check-up. This is a 15-minute session dedicated to teaching oral hygiene. This session will include watching of an educational video followed by a quiz, as well as the application of the methods taught in the sink (using plate developer and the Oral B electric toothbrush with special orthodontic head).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>oral hygiene advice given orally in the chair during the bonding appointment and at each check-up appointment.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group with active participation</intervention_name>
    <description>oral hygiene advice given orally in the chair during the bonding appointment and at each check-up appointment with a demonstration of brushing methods in the sink with active participation (use of plate developer and then the Oral B electric toothbrush with special orthodontic head) during the bonding appointment as well than at each check-up appointment.</description>
    <arm_group_label>Group with active participation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group with video and quizz</intervention_name>
    <description>oral hygiene advice given orally in the chair during the bonding appointment and at each check-up appointment with have an additional appointment between the device bonding appointment and the first check-up. This is a 15-minute session dedicated to teaching oral hygiene. This session will include watching of an educational video followed by a quiz, as well as the application of the methods taught in the sink (using plate developer and the Oral B electric toothbrush with special orthodontic head).</description>
    <arm_group_label>Group with video and quizz</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged 11 to 17 * years;&#xD;
&#xD;
          -  Patient with stable adolescent teeth, young adult or adult teeth;&#xD;
&#xD;
          -  Requiring a fixed orthodontic treatment without extraction (other than wisdom teeth)&#xD;
             at least to the maxillary arch;&#xD;
&#xD;
          -  Affiliated, himself or through his parents to a social security scheme;&#xD;
&#xD;
          -  Having received information on the protocol and having given free, informed and&#xD;
             written consent.&#xD;
&#xD;
          -  Whose holders of parental authority have received information on the protocol and have&#xD;
             given free, informed and written consent.&#xD;
&#xD;
               -  Aged under 18 at the end of the 6 months of participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with periodontal disease or progressive carious lesions;&#xD;
&#xD;
          -  Patient with a prosthetic crown or composite restoration on the central and / or&#xD;
             lateral maxillary incisor;&#xD;
&#xD;
          -  Patient with systemic disease, major syndrome or cleft palate;&#xD;
&#xD;
          -  Patient with an abnormal dental structure (eg fluorosis, MIH, imperfect amelogenesis,&#xD;
             etc.);&#xD;
&#xD;
          -  Patients taking long-term medication influencing periodontal health (corticosteroids,&#xD;
             anti-epileptics, etc.);&#xD;
&#xD;
          -  Patient with a physical or mental handicap preventing him from carrying out oral&#xD;
             hygiene maneuvers independently;&#xD;
&#xD;
          -  Patient refusing to use the products and instruments prescribed for the study;&#xD;
&#xD;
          -  Patients with dental agenesis;&#xD;
&#xD;
          -  Patients with poor command of the French language&#xD;
&#xD;
          -  Patient deprived of liberty by judicial or administrative decision or subject to a&#xD;
             legal protection measure;&#xD;
&#xD;
          -  Pregnant patient;&#xD;
&#xD;
          -  Smoking patient.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Damien BREZULIER, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Damien BREZULIER, Dr</last_name>
    <phone>02 99 28 24 00</phone>
    <email>damien.brezulier@chu-rennes.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de RENNES</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Damien BREZULIER, Dr</last_name>
      <phone>02 99 28 24 00</phone>
      <email>damien.brezulier@chu-rennes.fr</email>
    </contact>
    <investigator>
      <last_name>Damien BREZULIER, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>January 17, 2023</last_update_submitted>
  <last_update_submitted_qc>January 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>orthodontic appliance</keyword>
  <keyword>oral hygiene</keyword>
  <keyword>modified orthodontic plaque index</keyword>
  <keyword>Loë and Silness</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04444154
org study id: 35RC20_8945_MAHO
nct id: NCT04444154
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Orthodontic appliances have been shown to interfere with oral hygiene maneuvers by providing
      many additional sites for formation and retention of biofilm.

      Its accumulation is responsible for undesirable effects such as decays and periodontal
      pathologies. These lower the benefit / risk ratio of orthodontic treatments. In addition,
      their management is not negligible at the macroeconomic level.

      As such, it is more than necessary for the orthodontist to teach oral hygiene methods adapted
      to each of his patients fitted to limit the risk of appearance of biofilm.
Patients applying for orthodontic treatment with braces in the orthodontic unit of the Rennes
      dental center will be offered to participate in the study. For each patient, the inclusion
      and non-inclusion criteria will be checked, and consent and a document explaining the course
      of the study will be delivered to them personally. The duration of the study will be 6 months
      for each of them. Each will be randomized to one of three study groups. Throughout the study,
      patients in groups 1 and 2 will have to make 5 appointments. Group 3 patients must honor 6
      appointments.

      Patients in group 1 (control group) will receive oral hygiene advice given orally in the
      chair during the bonding appointment and at each check-up appointment. Patients in group 2
      will receive these same oral advice, associated with a demonstration of brushing methods in
      the sink with active participation (use of plate developer and then the Oral B electric
      toothbrush with special orthodontic head) during the bonding appointment as well than at each
      check-up appointment. Patients in group 3 will receive the same treatment as those in group 1
      but will have an additional appointment between the device bonding appointment and the first
      check-up. This is a 15-minute session dedicated to teaching oral hygiene. This session will
      include watching of an educational video followed by a quiz, as well as the application of
      the methods taught in the sink (using plate developer and the Oral B electric toothbrush with
      special orthodontic head).

      At the end of the appliance bonding appointment (first appointment) each patient (from each
      group) will leave with a hygiene kit including an electric toothbrush with two orthodontic
      heads, an Oral B toothpaste, from orthodontic wax and the analgesic prescription
      conventionally performed when installing a device.

      The plaque index readings, i.e. the taking of 3 macrophotographic shots (with reflex camera,
      allowing the MOP plaque index to be assessed in a second step), and the clinical index of
      gingival inflammation will be performed at each appointment (except during the dedicated
      session of group 3) by an examiner who will be blind from the group belonging to each
      patient.

      Exception made for the day of bonding, during which the plate index reading will be made just
      before the placement of the multi fasteners via the Loë and Silness plate index (which is an
      index adapted to patients not fitted).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective, monocentric, controlled, randomized study
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: The plaque index readings, i.e. the taking of 3 macrophotographic shots (with reflex camera, allowing the MOP plaque index to be assessed in a second step), and the clinical index of gingival inflammation will be performed at each appointment (except during the dedicated session of group 3) by an examiner who will be blind from the group belonging to each patient
measure: Compare the effectiveness of 3 methods of teaching oral hygiene in terms of controlling biofilm formation: MOP (Modified Orthodnotic Plaque Index) classification
time frame: 6 months of intervention
description: The average plaque index at six months after inclusion according to the MOP (Modified Orthodnotic Plaque Index) classification. It is evaluated on macro photography in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit.
measure: Compare the effectiveness of three teaching methods in oral hygiene for the control of gum inflammation: gingival index at six months after inclusion according to the Loë and Silness scale
time frame: 6 months after bonding the device.
description: The mean gingival index at six months after inclusion according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit.
measure: Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index
time frame: J0 (during the installation of the device)
description: The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The first is the MOP classification plate index. It is evaluated on macrophotographs in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit.
measure: Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale
time frame: J0 (during the installation of the device)
description: The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The second is the gingival index according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit.
measure: Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index
time frame: at 1½ months after installation of the device
description: The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The first is the MOP classification plate index. It is evaluated on macrophotographs in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit.
measure: Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale
time frame: at 1½ months after installation of the device
description: The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The second is the gingival index according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit.
measure: Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index
time frame: at 3 months after installation of the device
description: The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The first is the MOP classification plate index. It is evaluated on macrophotographs in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit.
measure: Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale
time frame: at 3 months after installation of the device
description: The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The second is the gingival index according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit.
measure: Compare the effectiveness of three methods of teaching oral hygiene over time: MOP classification plate index
time frame: at 4½ months after installation of the device
description: The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The first is the MOP classification plate index. It is evaluated on macrophotographs in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit.
measure: Compare the effectiveness of three methods of teaching oral hygiene over time: gingival index according to the Loë and Silness scale
time frame: at 4½ months after installation of the device
description: The comparison of the three treatment groups as a function of time will be based on two judgment criteria. The second is the gingival index according to the Loë and Silness scale. It will be evaluated in the mouth in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 3 for each side of each tooth, which makes an average score of 0 to 144 for the maxillary arch. 0 corresponds to no bleeding on probing whereas 3 characterizes a situation of spontaneous bleeding of the gum, worst situation. The score is expressed in absolute value without unit.
arm group label: Control group
arm group type: Active Comparator
description: oral hygiene advice given orally
arm group label: Group with active participation
arm group type: Active Comparator
description: oral hygiene advice given orally and demonstration of brushing methods in the sink with active participation
arm group label: Group with video and quizz
arm group type: Experimental
description: oral hygiene advice given orally and an additional appointment between the device bonding appointment and the first check-up. This is a 15-minute session dedicated to teaching oral hygiene. This session will include watching of an educational video followed by a quiz, as well as the application of the methods taught in the sink (using plate developer and the Oral B electric toothbrush with special orthodontic head).
intervention type: Behavioral
intervention name: Control group
description: oral hygiene advice given orally in the chair during the bonding appointment and at each check-up appointment.
arm group label: Control group
intervention type: Behavioral
intervention name: Group with active participation
description: oral hygiene advice given orally in the chair during the bonding appointment and at each check-up appointment with a demonstration of brushing methods in the sink with active participation (use of plate developer and then the Oral B electric toothbrush with special orthodontic head) during the bonding appointment as well than at each check-up appointment.
arm group label: Group with active participation
intervention type: Behavioral
intervention name: Group with video and quizz
description: oral hygiene advice given orally in the chair during the bonding appointment and at each check-up appointment with have an additional appointment between the device bonding appointment and the first check-up. This is a 15-minute session dedicated to teaching oral hygiene. This session will include watching of an educational video followed by a quiz, as well as the application of the methods taught in the sink (using plate developer and the Oral B electric toothbrush with special orthodontic head).
arm group label: Group with video and quizz
criteria: 
gender: All
minimum age: 11 Years
maximum age: 17 Years
healthy volunteers: No
last name: Damien BREZULIER, Dr
role: Principal Investigator
affiliation: Rennes University Hospital
last name: Damien BREZULIER, Dr
phone: 02 99 28 24 00
email: damien.brezulier@chu-rennes.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
sharing ipd: No