<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/NCT04464941</url>
  </required_header>
  <id_info>
    <org_study_id>RD103035018</org_study_id>
    <nct_id>NCT04464941</nct_id>
  </id_info>
  <brief_title>Oral Health Promotion Program for Persons With Severe Mental Illness</brief_title>
  <official_title>Oral Health Promotion Program for Persons With Severe Mental Illness: A Cluster Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Bing Show Chwan Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Bing Show Chwan Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A cluster randomized controlled study was carried out in chronic psychiatric wards of a&#xD;
      general hospital in central Taiwan. Sixty-eight eligible male individuals admitted to 2 wards&#xD;
      were randomly assigned to an experimental and a control group. Participants in the&#xD;
      experimental group underwent an oral health promotion program that consisted of biweekly&#xD;
      group education sessions, and a 12-week individual behavioral modification for oral hygiene&#xD;
      course. The participants in the control group received usual care only. Dental plaque&#xD;
      (measured by the Plaque Control Index) was examined by a single dentist before and after the&#xD;
      experiment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 21, 2016</start_date>
  <completion_date type="Actual">July 10, 2016</completion_date>
  <primary_completion_date type="Actual">June 30, 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>
    <intervention_model_description>Cluster Randomized Controlled Study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Assessment of dental plaque was carried out by a single dentist, who was blind to group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Dental Plaque Index</measure>
    <time_frame>12-week</time_frame>
    <description>Plaque Control Index (PCI) developed by O'Leary et al. to score the primary outcome, plaque accumulation, on the surfaces of the teeth. The score was computed by the existence of plaque divided by all examined surfaces; a higher plaque index indicated poor oral hygiene. We calculated a person-level plaque score by averaging plaque scores for all teeth at each examination.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Evaluate the Effects of an Oral Health Promotion Program</condition>
  <arm_group>
    <arm_group_label>oral health promotion program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The oral health promotion program was a composite intervention with both group and individual components. The group intervention consisted of:&#xD;
1. Group oral health education 2. Display of Bass tooth-brushing methods 3. Broadcasting of songs as tooth-brushing reminders; The individual interventions included:&#xD;
1. Instruction in the Bass tooth-brushing method 2. Individual behavioral modification method</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>a composite intervention with both group and individual components for oral health promotion program</intervention_name>
    <description>The group intervention consisted of:&#xD;
1. Group oral health education 2. Display of Bass tooth-brushing methods 3. Broadcasting of songs as tooth-brushing reminders; The individual interventions included:&#xD;
1. Instruction in the Bass tooth-brushing method, 2. Individual behavioral modification method</description>
    <arm_group_label>oral health promotion program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted in chronic psychiatric wards were eligible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  significant cognitive disabilities, severe hearing impairment, orthodontic appliances,&#xD;
             an edentulous status, or a handicap when tooth-brushing&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Bing Show Chwan Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Po-Ren Teng</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>oral health, promotion program, plaque index, mental illness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_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/NCT04464941
org study id: RD103035018
nct id: NCT04464941
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A cluster randomized controlled study was carried out in chronic psychiatric wards of a
      general hospital in central Taiwan. Sixty-eight eligible male individuals admitted to 2 wards
      were randomly assigned to an experimental and a control group. Participants in the
      experimental group underwent an oral health promotion program that consisted of biweekly
      group education sessions, and a 12-week individual behavioral modification for oral hygiene
      course. The participants in the control group received usual care only. Dental plaque
      (measured by the Plaque Control Index) was examined by a single dentist before and after the
      experiment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cluster Randomized Controlled Study
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Assessment of dental plaque was carried out by a single dentist, who was blind to group assignment.
measure: Dental Plaque Index
time frame: 12-week
description: Plaque Control Index (PCI) developed by O'Leary et al. to score the primary outcome, plaque accumulation, on the surfaces of the teeth. The score was computed by the existence of plaque divided by all examined surfaces; a higher plaque index indicated poor oral hygiene. We calculated a person-level plaque score by averaging plaque scores for all teeth at each examination.
arm group label: oral health promotion program
arm group type: Experimental
description: The oral health promotion program was a composite intervention with both group and individual components. The group intervention consisted of:
1. Group oral health education 2. Display of Bass tooth-brushing methods 3. Broadcasting of songs as tooth-brushing reminders; The individual interventions included:
1. Instruction in the Bass tooth-brushing method 2. Individual behavioral modification method
arm group label: Usual care group
arm group type: No Intervention
intervention type: Behavioral
intervention name: a composite intervention with both group and individual components for oral health promotion program
description: The group intervention consisted of:
1. Group oral health education 2. Display of Bass tooth-brushing methods 3. Broadcasting of songs as tooth-brushing reminders; The individual interventions included:
1. Instruction in the Bass tooth-brushing method, 2. Individual behavioral modification method
arm group label: oral health promotion program
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Chang Bing Show Chwan Memorial Hospital
investigator full name: Po-Ren Teng
investigator title: MD, PhD
mesh term: Mental Disorders