<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/NCT03750708</url>
  </required_header>
  <id_info>
    <org_study_id>APHP180025</org_study_id>
    <secondary_id>2018-A02062-53</secondary_id>
    <nct_id>NCT03750708</nct_id>
  </id_info>
  <brief_title>Oral Hygiene and Connected Toothbrush Before Alveolar Bone Graft for Cleft Lip and Palate</brief_title>
  <acronym>HBD-GPP</acronym>
  <official_title>Assessment of the Impact of the Use of the ARA 2 Connected Toothbrush on Short-term Oral Hygiene During the Pre-operative Period of Alveolar Bone Grafts for Patients With Unilateral or Bilateral Cleft Lip and Palate. Oral Hygiene and Connected Toothbrush Before Alveolar Bone Graft for Cleft Lip and Palate.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      Alveolar bone graft is an essential step in the primary surgical treatment of unilateral or&#xD;
      bilateral cleft lip and palate. The procedure involves repairing the alveolar cleft by an&#xD;
      autologous iliac bone graft.&#xD;
&#xD;
      Clinical experience suggests that a large number of the post-operative complications in this&#xD;
      procedure are related to pre-and post-operative oral hygiene issues.&#xD;
&#xD;
      The main objective of this research is the evaluation of pre-operative oral hygiene in&#xD;
      children benefiting from alveolar bone graft and having a type Quad Helix orthodontic device.&#xD;
&#xD;
      The secondary objectives are to describe the use of the Ara ® Toothbrush by a population of&#xD;
      children with a cleft lip and palate and to know whether the use of the Ara ® toothbrush has&#xD;
      an influence on the occurrence of post-operative complications evaluated at 6 months of&#xD;
      intervention (delays in scarring, suture dehiscence, fistulas, surgical site infections,&#xD;
      total or partial graft loss).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alveolar bone graft is an essential step in the primary surgical treatment of unilateral or&#xD;
      bilateral cleft lip and palate. The procedure involves repairing the alveolar cleft by an&#xD;
      autologous iliac bone graft.&#xD;
&#xD;
      Clinical experience suggests that many post-operative complications in alveolar bone grafts&#xD;
      are related to pre- and post-operative oral hygiene issues. This surgical procedure therefore&#xD;
      requires optimal pre-and post-operative oral hygiene.&#xD;
&#xD;
      In addition, children with cleft lip and palate have a higher risk of oral hygiene issues,&#xD;
      partly due to the systematic use of orthodontic devices such as Quad Helix.&#xD;
&#xD;
      Prevention of post-operative complications (delays in scarring, scar dehiscence, fistulas,&#xD;
      infections of the surgical site, total or partial losses of the graft) requires patient&#xD;
      education efforts in order to improve pre-operative oral hygiene.&#xD;
&#xD;
      Connected devices allow an objective follow-up tooth brushing and could be effective&#xD;
      instruments in the primary and secondary prevention of pre-and post-operative complications&#xD;
      linked to the alveolar bone graft, via a better oral hygiene.&#xD;
&#xD;
      Connected health is a growing and promising technology. It is important for physicians to&#xD;
      demonstrate the efficiency of connected objects. Recent medico-economic studies have&#xD;
      demonstrated the added value of connected devices as part of a general health monitoring, but&#xD;
      more prospective assessments are required, especially in pediatric populations. Also, because&#xD;
      of its importance in terms of public health, the field of oral hygiene is at the forefront of&#xD;
      connected health applications.&#xD;
&#xD;
      The main objective of the research is the evaluation of pre-operative oral hygiene of&#xD;
      children benefiting from an alveolar bone graft and having a type Quad Helix orthodontic&#xD;
      device.&#xD;
&#xD;
      The secondary objectives are to describe the use of the Ara ® Toothbrush by a population of&#xD;
      children with a cleft lip and palate and to know whether the use of the Ara ® toothbrush has&#xD;
      an influence on the occurrence of post-operative complications evaluated at 6 months of&#xD;
      intervention (delays in scarring, scar dehiscence, fistulas, surgical site infections, total&#xD;
      or partial losses of the graft).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unsuccessful study&#xD;
  </why_stopped>
  <start_date type="Actual">January 28, 2019</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oral hygiene score : CAO</measure>
    <time_frame>Consultation 1 month before alveolar bone graft</time_frame>
    <description>Individual CAO = C + A + O C : number of teeth decayed. A : number of teeth absent due to caries. O : number of teeth permanently blocked.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral hygiene score : CPITN</measure>
    <time_frame>Consultation 1 month before alveolar bone graft</time_frame>
    <description>CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral hygiene score : Silness-Löe Index</measure>
    <time_frame>Consultation 1 month before alveolar bone graft</time_frame>
    <description>Silness-Löe Index : index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in oral hygiene score : CAO</measure>
    <time_frame>Consultation 1 day before alveolar bone graft</time_frame>
    <description>Individual CAO = C + A + O C : number of teeth decayed. A : number of teeth absent due to caries. O : number of teeth permanently blocked.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in oral hygiene score : CPITN</measure>
    <time_frame>Consultation 1 day before alveolar bone graft</time_frame>
    <description>CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in oral hygiene score : Silness-Löe Index</measure>
    <time_frame>Consultation 1 day before alveolar bone graft</time_frame>
    <description>Silness-Löe Index : index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Description of the use of the Ara ® Toothbrush</measure>
    <time_frame>Consultation at 1 day before alveolar bone graft</time_frame>
    <description>Recorded data from the use of the Ara ® KOLIBREE tooth brush (Kolibree Pro interface)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of post-operative complications</measure>
    <time_frame>Consultation 6 months after alveolar bone graft</time_frame>
    <description>Delays in scarring, scar dehiscence, fistulas, infections of the surgical site, total or partial losses of the graft</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cleft Lip and Palate</condition>
  <arm_group>
    <arm_group_label>Ara® KOLIBREE toothbrush</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The Ara® KOLIBREE tooth brush is given to the child at the usual consultation one month before alveolar bone graft.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without Ara® KOLIBREE tooth brush</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual consultation one month before alveolar bone graft.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ara® KOLIBREE tooth brush</intervention_name>
    <description>Use of the Ara® KOLIBREE tooth brush by the child one month before alveolar bone graft up to the time of surgery.&#xD;
The Ara® KOLIBREE tooth brush saves brush tracking data.</description>
    <arm_group_label>Ara® KOLIBREE toothbrush</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 5 to 12 years.&#xD;
&#xD;
          -  Children benefiting from iliac alveolar bone graft (first side for bilateral clefts)&#xD;
             as part of the surgical management of unilateral a bilateral cleft lip and palate.&#xD;
&#xD;
          -  Children benefiting from a pre-operative orthodontic treatment using Quad Helix type&#xD;
             (usual protocol).&#xD;
&#xD;
          -  Collection of the consent of the persons holding the parental authority and of the&#xD;
             child participating in the study.&#xD;
&#xD;
          -  Affiliation to social security.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment preventing the satisfactory education for the use of the&#xD;
             connected device.&#xD;
&#xD;
          -  Chronic disease potentially favouring dental infections (congenital or acquired&#xD;
             immunosuppression, congenital enamel disease).&#xD;
&#xD;
          -  Children undergoing secondary alveolar bone grafts (after an unsatisfactory first&#xD;
             alveolar bone graft) or undergoing surgery for the second side in bilateral clefts.&#xD;
&#xD;
          -  Children participating in another interventional research.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roman Hossein Khonsari, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Necker - Enfants Malades</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alveolar bone graft complications, oral hygiene, cleft lip and palate, connected health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cleft Lip</mesh_term>
  </condition_browse>
  <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/NCT03750708
org study id: APHP180025
secondary id: 2018-A02062-53
nct id: NCT03750708
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Alveolar bone graft is an essential step in the primary surgical treatment of unilateral or
      bilateral cleft lip and palate. The procedure involves repairing the alveolar cleft by an
      autologous iliac bone graft.

      Clinical experience suggests that a large number of the post-operative complications in this
      procedure are related to pre-and post-operative oral hygiene issues.

      The main objective of this research is the evaluation of pre-operative oral hygiene in
      children benefiting from alveolar bone graft and having a type Quad Helix orthodontic device.

      The secondary objectives are to describe the use of the Ara ® Toothbrush by a population of
      children with a cleft lip and palate and to know whether the use of the Ara ® toothbrush has
      an influence on the occurrence of post-operative complications evaluated at 6 months of
      intervention (delays in scarring, suture dehiscence, fistulas, surgical site infections,
      total or partial graft loss).
Alveolar bone graft is an essential step in the primary surgical treatment of unilateral or
      bilateral cleft lip and palate. The procedure involves repairing the alveolar cleft by an
      autologous iliac bone graft.

      Clinical experience suggests that many post-operative complications in alveolar bone grafts
      are related to pre- and post-operative oral hygiene issues. This surgical procedure therefore
      requires optimal pre-and post-operative oral hygiene.

      In addition, children with cleft lip and palate have a higher risk of oral hygiene issues,
      partly due to the systematic use of orthodontic devices such as Quad Helix.

      Prevention of post-operative complications (delays in scarring, scar dehiscence, fistulas,
      infections of the surgical site, total or partial losses of the graft) requires patient
      education efforts in order to improve pre-operative oral hygiene.

      Connected devices allow an objective follow-up tooth brushing and could be effective
      instruments in the primary and secondary prevention of pre-and post-operative complications
      linked to the alveolar bone graft, via a better oral hygiene.

      Connected health is a growing and promising technology. It is important for physicians to
      demonstrate the efficiency of connected objects. Recent medico-economic studies have
      demonstrated the added value of connected devices as part of a general health monitoring, but
      more prospective assessments are required, especially in pediatric populations. Also, because
      of its importance in terms of public health, the field of oral hygiene is at the forefront of
      connected health applications.

      The main objective of the research is the evaluation of pre-operative oral hygiene of
      children benefiting from an alveolar bone graft and having a type Quad Helix orthodontic
      device.

      The secondary objectives are to describe the use of the Ara ® Toothbrush by a population of
      children with a cleft lip and palate and to know whether the use of the Ara ® toothbrush has
      an influence on the occurrence of post-operative complications evaluated at 6 months of
      intervention (delays in scarring, scar dehiscence, fistulas, surgical site infections, total
      or partial losses of the graft).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Oral hygiene score : CAO
time frame: Consultation 1 month before alveolar bone graft
description: Individual CAO = C + A + O C : number of teeth decayed. A : number of teeth absent due to caries. O : number of teeth permanently blocked.
measure: Oral hygiene score : CPITN
time frame: Consultation 1 month before alveolar bone graft
description: CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).
measure: Oral hygiene score : Silness-Löe Index
time frame: Consultation 1 month before alveolar bone graft
description: Silness-Löe Index : index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).
measure: Changes in oral hygiene score : CAO
time frame: Consultation 1 day before alveolar bone graft
description: Individual CAO = C + A + O C : number of teeth decayed. A : number of teeth absent due to caries. O : number of teeth permanently blocked.
measure: Changes in oral hygiene score : CPITN
time frame: Consultation 1 day before alveolar bone graft
description: CPITN : Community Periodontal Index of Treatment Needs : assessment of the periodontal status (index 0 (healthy) to 4).
measure: Changes in oral hygiene score : Silness-Löe Index
time frame: Consultation 1 day before alveolar bone graft
description: Silness-Löe Index : index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).
measure: Description of the use of the Ara ® Toothbrush
time frame: Consultation at 1 day before alveolar bone graft
description: Recorded data from the use of the Ara ® KOLIBREE tooth brush (Kolibree Pro interface)
measure: Occurrence of post-operative complications
time frame: Consultation 6 months after alveolar bone graft
description: Delays in scarring, scar dehiscence, fistulas, infections of the surgical site, total or partial losses of the graft
arm group label: Ara® KOLIBREE toothbrush
arm group type: Other
description: The Ara® KOLIBREE tooth brush is given to the child at the usual consultation one month before alveolar bone graft.
arm group label: Without Ara® KOLIBREE tooth brush
arm group type: No Intervention
description: Usual consultation one month before alveolar bone graft.
intervention type: Device
intervention name: Ara® KOLIBREE tooth brush
description: Use of the Ara® KOLIBREE tooth brush by the child one month before alveolar bone graft up to the time of surgery.
The Ara® KOLIBREE tooth brush saves brush tracking data.
arm group label: Ara® KOLIBREE toothbrush
criteria: 
gender: All
minimum age: 4 Years
maximum age: 11 Years
healthy volunteers: No
last name: Roman Hossein Khonsari, MD PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Cleft Lip
sharing ipd: No