<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/NCT03827551</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2018/44</org_study_id>
    <nct_id>NCT03827551</nct_id>
  </id_info>
  <brief_title>Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients</brief_title>
  <acronym>PARKIDENT</acronym>
  <official_title>Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Capionis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>France Parkinson Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Bordeaux</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>
      This is a prospective interventional clinical study whose main objective is to determine the&#xD;
      impact of oral hygiene guidance on the oral health status of patients with Parkinson disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Caries and periodontitis are infectious diseases that can eventually lead to the loss of the&#xD;
      dental organ. The masticatory deficit engendered will have repercussions on the general state&#xD;
      of the subject and on his quality of life (pains, difficulties of feeding which can cause&#xD;
      nutritional deficiencies ...). The systematic review of the literature, despite low levels of&#xD;
      evidence, shows that there is an influence of Parkinson's disease on oral health. Our goal is&#xD;
      therefore to determine the impact of implementing appropriate oral hygiene measures on&#xD;
      improving the quality of life of patients with Parkinson's disease.&#xD;
&#xD;
      This is a 40-patient, interventional, preliminary study that will rely on indicators of oral&#xD;
      health status (DMF, Periodontal Index, presence of pathogenic bacteria), as well as a&#xD;
      questionnaire measuring impact of oral conditions on patient well-being (OHIP-14). These data&#xD;
      will be collected before and after the implementation of the hygiene measures, within a&#xD;
      period of 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 29, 2019</start_date>
  <completion_date type="Actual">April 6, 2021</completion_date>
  <primary_completion_date type="Actual">April 6, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decayed Missing Filled (DMF) index score</measure>
    <time_frame>6 months after inclusion</time_frame>
    <description>Min value : 0 (good oral health), Max value : 32</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of cariogenic bacteria in saliva and dental film</measure>
    <time_frame>6 months after inclusion</time_frame>
    <description>Streptococcus mutans and Lactobacillus</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of periodontopathogenic bacteria in saliva and dental film</measure>
    <time_frame>6 months after inclusion</time_frame>
    <description>Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Peptostreptococcus micros, Eikenella corrodens, Campylobacter rectus</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decayed Missing Filled (DMF) index score</measure>
    <time_frame>Inclusion visit (Day 0)</time_frame>
    <description>Min value : 0 (good oral health), Max value : 32</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of cariogenic bacteria in saliva and dental film</measure>
    <time_frame>Inclusion visit (Day 0)</time_frame>
    <description>Streptococcus mutans and Lactobacillus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of periodontopathogenic bacteria in saliva and dental film</measure>
    <time_frame>Inclusion visit (Day 0)</time_frame>
    <description>Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Peptostreptococcus micros, Eikenella corrodens, Campylobacter rectus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Oral Health Impact Profile-14 (OHIP-14)</measure>
    <time_frame>Inclusion Visit (Day 0) and 6 month after</time_frame>
    <description>Min value : 14, Max value : 70 (satisfactory oral health)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Geriatric/General Oral Health Assessment Index (GOHAI)</measure>
    <time_frame>Inclusion Visit (Day 0) and 6 month after</time_frame>
    <description>Min value : 12, Max value : 60 (satisfactory oral health)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saliva pH</measure>
    <time_frame>Inclusion Visit (Day 0) and 6 month after</time_frame>
    <description>Normal / Acid / Very acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantification of saliva flow</measure>
    <time_frame>Inclusion Visit (Day 0) and 6 month after</time_frame>
    <description>Normal / Low</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Community Periodontal Index of Treatment Needs (CPITN)</measure>
    <time_frame>Inclusion Visit (Day 0) and 6 month after</time_frame>
    <description>CPI Min value : 0 (healthy periodontium), Max value : 4 ; TN Min value : 0 (No periodontal treatment needed), Max value : 3</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Oral Health</condition>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Parkinson's Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Delivery of oral hygiene advices</intervention_name>
    <description>Patients will benefit from hygiene advice and maintenance of good oral health. No treatment will be administered as part of this study. Patients will continue their usual treatment according to the contraindications. Patients will benefit from salivary sampling and a collection of oral bacteria contained in the dental plaque using paper tips. These reviews will be conducted during the Inclusion Visit and the 6 month Follow-Up Visit.</description>
    <arm_group_label>Parkinson's Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major patient&#xD;
&#xD;
          -  Patient with Parkinson disease&#xD;
&#xD;
          -  Able to give written informed consent&#xD;
&#xD;
          -  Affiliated to French health care system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under tutorship and curatorship&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patient wearing subtotal or total dental prosthesis&#xD;
&#xD;
          -  Antibiotic treatment or antiseptic mouthwashes in the month prior to sampling&#xD;
&#xD;
          -  Patient with less than 6 teeth distributed on maxilla and mandible&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral Health</keyword>
  <keyword>Parkinson Disease</keyword>
  <keyword>Tooth cavities</keyword>
  <keyword>Saliva</keyword>
  <keyword>Mucosa</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT03827551
org study id: CHUBX 2018/44
nct id: NCT03827551
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective interventional clinical study whose main objective is to determine the
      impact of oral hygiene guidance on the oral health status of patients with Parkinson disease
Caries and periodontitis are infectious diseases that can eventually lead to the loss of the
      dental organ. The masticatory deficit engendered will have repercussions on the general state
      of the subject and on his quality of life (pains, difficulties of feeding which can cause
      nutritional deficiencies ...). The systematic review of the literature, despite low levels of
      evidence, shows that there is an influence of Parkinson's disease on oral health. Our goal is
      therefore to determine the impact of implementing appropriate oral hygiene measures on
      improving the quality of life of patients with Parkinson's disease.

      This is a 40-patient, interventional, preliminary study that will rely on indicators of oral
      health status (DMF, Periodontal Index, presence of pathogenic bacteria), as well as a
      questionnaire measuring impact of oral conditions on patient well-being (OHIP-14). These data
      will be collected before and after the implementation of the hygiene measures, within a
      period of 6 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Decayed Missing Filled (DMF) index score
time frame: 6 months after inclusion
description: Min value : 0 (good oral health), Max value : 32
measure: Presence of cariogenic bacteria in saliva and dental film
time frame: 6 months after inclusion
description: Streptococcus mutans and Lactobacillus
measure: Presence of periodontopathogenic bacteria in saliva and dental film
time frame: 6 months after inclusion
description: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Peptostreptococcus micros, Eikenella corrodens, Campylobacter rectus
measure: Decayed Missing Filled (DMF) index score
time frame: Inclusion visit (Day 0)
description: Min value : 0 (good oral health), Max value : 32
measure: Presence of cariogenic bacteria in saliva and dental film
time frame: Inclusion visit (Day 0)
description: Streptococcus mutans and Lactobacillus
measure: Presence of periodontopathogenic bacteria in saliva and dental film
time frame: Inclusion visit (Day 0)
description: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Peptostreptococcus micros, Eikenella corrodens, Campylobacter rectus
measure: Change of Oral Health Impact Profile-14 (OHIP-14)
time frame: Inclusion Visit (Day 0) and 6 month after
description: Min value : 14, Max value : 70 (satisfactory oral health)
measure: Change of Geriatric/General Oral Health Assessment Index (GOHAI)
time frame: Inclusion Visit (Day 0) and 6 month after
description: Min value : 12, Max value : 60 (satisfactory oral health)
measure: Saliva pH
time frame: Inclusion Visit (Day 0) and 6 month after
description: Normal / Acid / Very acid
measure: Quantification of saliva flow
time frame: Inclusion Visit (Day 0) and 6 month after
description: Normal / Low
measure: Change of Community Periodontal Index of Treatment Needs (CPITN)
time frame: Inclusion Visit (Day 0) and 6 month after
description: CPI Min value : 0 (healthy periodontium), Max value : 4 ; TN Min value : 0 (No periodontal treatment needed), Max value : 3
arm group label: Parkinson's Patients
arm group type: Experimental
intervention type: Behavioral
intervention name: Delivery of oral hygiene advices
description: Patients will benefit from hygiene advice and maintenance of good oral health. No treatment will be administered as part of this study. Patients will continue their usual treatment according to the contraindications. Patients will benefit from salivary sampling and a collection of oral bacteria contained in the dental plaque using paper tips. These reviews will be conducted during the Inclusion Visit and the 6 month Follow-Up Visit.
arm group label: Parkinson's Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No