<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/NCT03234231</url>
  </required_header>
  <id_info>
    <org_study_id>HM01</org_study_id>
    <nct_id>NCT03234231</nct_id>
  </id_info>
  <brief_title>Supervised Brushing Programme for Intellectual Disabled Students</brief_title>
  <official_title>Supervised Toothbrushing Programme and Oral Health Education for Intellectual Disabled Students: A Cluster Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MD Equation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MD Equation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intellectual disabled persons faced more dental problems. According to a medical review paper&#xD;
      of international and local studies, this group has poorer dental hygiene, more severe gum&#xD;
      disease and more untreated caries. In 2010, a report from the guardians in Hong Kong&#xD;
      mentioned that most adults with intellectual disability cannot clean their teeth, the have&#xD;
      dental problems and it is very difficult for intellectually disabled students to co-operate&#xD;
      during the dental treatment. In order to alleviate their dental problems, supervised&#xD;
      toothbrushing programme and an oral health education talk are proposed. The investigators&#xD;
      investigate the effectiveness of the supervised toothbrushing programme and an oral health&#xD;
      education talk. The target group of the study is mild to moderate grade intellectual disabled&#xD;
      students of special schools in Hong Kong. A clustered randomised controlled trial design is&#xD;
      adopted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intellectual disabled persons faced more dental problems. According to a medical review paper&#xD;
      of international and local studies, this group has poorer dental hygiene, more severe gum&#xD;
      disease and more untreated caries. In 2010, a report from the guardians in Hong Kong&#xD;
      mentioned that most adults with intellectual disability cannot clean their teeth, the have&#xD;
      dental problems and it is very difficult for intellectually disabled students to co-operate&#xD;
      during the dental treatment. In order to alleviate their dental problems, supervised&#xD;
      toothbrushing programme and an oral health education talk are proposed. The investigators&#xD;
      investigate the effectiveness of the supervised toothbrushing programme and an oral health&#xD;
      education talk. The target group of the study is mild to moderate grade intellectual disabled&#xD;
      students of special schools in Hong Kong. A clustered randomised controlled trial design is&#xD;
      adopted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2018</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 trial</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>data entered by independent clerical staff with no information of the detail of the study outcomes assessor will not be told which group of subjects are examined but there is a chance that the subjects tell him/her</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Gingivitis score</measure>
    <time_frame>A study period of 3 months</time_frame>
    <description>Measuring the change of oral conditions of the students</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plaque score</measure>
    <time_frame>A study period of 3 months</time_frame>
    <description>Measuring the change of oral conditions of the students</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">602</enrollment>
  <condition>Oral Health</condition>
  <condition>Intellectual Disability</condition>
  <condition>Randomized Controlled Trial</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group receive nothing during the study period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 3-month supervised tooth brushing programme will be provided to the students. An oral health education talk with written material delivered to the carers and the students</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>3-month supervised tooth brushing programme</intervention_name>
    <description>One or a few dental hygienists, who are trained to teach how to brush and provide scaling, will supervise the students to brush daily in school for three months.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>oral health education talk</intervention_name>
    <description>It is conducted by a dentist, while written materials will be delivered to the students and their carers.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild and moderate grade intellectual disabled students in special schools.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Those students who have simultaneously joined other oral health programme during&#xD;
             the study period.&#xD;
&#xD;
          -  2. Those students with the presence of conditions rendering a need of antibiotic&#xD;
             prophylaxis prior to periodontal examination e.g. rheumatic heart disease.&#xD;
&#xD;
          -  3. Uncooperative students that oral examination is not possible.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cecilia Young, BDS(HK),MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>MD Equation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cecilia Young, BDS(HK),MPH</last_name>
    <phone>(+852) 23618684</phone>
    <email>ceciliatyp@yahoo.com.hk</email>
  </overall_contact>
  <link>
    <url>http://www.hkjcpmh.org.hk/uploads/books/pdf/178344fa63dc4fa193b998268e345219.pdf</url>
    <description>A report from the guardians in Hong Kong mentioned that most adults with intellectual disability cannot clean their teeth, the have dental problems and it is very difficult for them to co-operate during the dental treatment. (Chinese only)</description>
  </link>
  <reference>
    <citation>Anders PL, Davis EL. Oral health of patients with intellectual disabilities: a systematic review. Spec Care Dentist. 2010 May-Jun;30(3):110-7. doi: 10.1111/j.1754-4505.2010.00136.x.</citation>
    <PMID>20500706</PMID>
  </reference>
  <reference>
    <citation>Stefanovska E, Nakova M, Radojkova-Nikolovska V, Ristoska S. Tooth-brushing intervention programme among children with mental handicap. Bratisl Lek Listy. 2010;111(5):299-302.</citation>
    <PMID>20568423</PMID>
  </reference>
  <reference>
    <citation>Shyama M, Al-Mutawa SA, Honkala S, Honkala E. Supervised toothbrushing and oral health education program in Kuwait for children and young adults with Down syndrome. Spec Care Dentist. 2003;23(3):94-9. doi: 10.1111/j.1754-4505.2003.tb01668.x.</citation>
    <PMID>14650557</PMID>
  </reference>
  <reference>
    <citation>Rabe-Jablonska J, Bienkiewicz W. [Anxiety disorders in the fourth edition of the classification of mental disorders prepared by the American Psychiatric Association: diagnostic and statistical manual of mental disorders (DMS-IV -- options book]. Psychiatr Pol. 1994 Mar-Apr;28(2):255-68. Polish.</citation>
    <PMID>8208869</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>March 29, 2018</last_update_submitted>
  <last_update_submitted_qc>March 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>MD Equation</investigator_affiliation>
    <investigator_full_name>Cecilia Young</investigator_full_name>
    <investigator_title>Founder</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intellectual Disability</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/NCT03234231
org study id: HM01
nct id: NCT03234231
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Intellectual disabled persons faced more dental problems. According to a medical review paper
      of international and local studies, this group has poorer dental hygiene, more severe gum
      disease and more untreated caries. In 2010, a report from the guardians in Hong Kong
      mentioned that most adults with intellectual disability cannot clean their teeth, the have
      dental problems and it is very difficult for intellectually disabled students to co-operate
      during the dental treatment. In order to alleviate their dental problems, supervised
      toothbrushing programme and an oral health education talk are proposed. The investigators
      investigate the effectiveness of the supervised toothbrushing programme and an oral health
      education talk. The target group of the study is mild to moderate grade intellectual disabled
      students of special schools in Hong Kong. A clustered randomised controlled trial design is
      adopted.
Intellectual disabled persons faced more dental problems. According to a medical review paper
      of international and local studies, this group has poorer dental hygiene, more severe gum
      disease and more untreated caries. In 2010, a report from the guardians in Hong Kong
      mentioned that most adults with intellectual disability cannot clean their teeth, the have
      dental problems and it is very difficult for intellectually disabled students to co-operate
      during the dental treatment. In order to alleviate their dental problems, supervised
      toothbrushing programme and an oral health education talk are proposed. The investigators
      investigate the effectiveness of the supervised toothbrushing programme and an oral health
      education talk. The target group of the study is mild to moderate grade intellectual disabled
      students of special schools in Hong Kong. A clustered randomised controlled trial design is
      adopted.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cluster randomized controlled trial
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
masking description: data entered by independent clerical staff with no information of the detail of the study outcomes assessor will not be told which group of subjects are examined but there is a chance that the subjects tell him/her
measure: Gingivitis score
time frame: A study period of 3 months
description: Measuring the change of oral conditions of the students
measure: Plaque score
time frame: A study period of 3 months
description: Measuring the change of oral conditions of the students
arm group label: Control Group
arm group type: No Intervention
description: This group receive nothing during the study period.
arm group label: Intervention Group
arm group type: Experimental
description: A 3-month supervised tooth brushing programme will be provided to the students. An oral health education talk with written material delivered to the carers and the students
intervention type: Behavioral
intervention name: 3-month supervised tooth brushing programme
description: One or a few dental hygienists, who are trained to teach how to brush and provide scaling, will supervise the students to brush daily in school for three months.
arm group label: Intervention Group
intervention type: Behavioral
intervention name: oral health education talk
description: It is conducted by a dentist, while written materials will be delivered to the students and their carers.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
last name: Cecilia Young, BDS(HK),MPH
role: Principal Investigator
affiliation: MD Equation
last name: Cecilia Young, BDS(HK),MPH
phone: (+852) 23618684
email: ceciliatyp@yahoo.com.hk
url: http://www.hkjcpmh.org.hk/uploads/books/pdf/178344fa63dc4fa193b998268e345219.pdf
description: A report from the guardians in Hong Kong mentioned that most adults with intellectual disability cannot clean their teeth, the have dental problems and it is very difficult for them to co-operate during the dental treatment. (Chinese only)
citation: Anders PL, Davis EL. Oral health of patients with intellectual disabilities: a systematic review. Spec Care Dentist. 2010 May-Jun;30(3):110-7. doi: 10.1111/j.1754-4505.2010.00136.x.
PMID: 20500706
citation: Stefanovska E, Nakova M, Radojkova-Nikolovska V, Ristoska S. Tooth-brushing intervention programme among children with mental handicap. Bratisl Lek Listy. 2010;111(5):299-302.
PMID: 20568423
citation: Shyama M, Al-Mutawa SA, Honkala S, Honkala E. Supervised toothbrushing and oral health education program in Kuwait for children and young adults with Down syndrome. Spec Care Dentist. 2003;23(3):94-9. doi: 10.1111/j.1754-4505.2003.tb01668.x.
PMID: 14650557
citation: Rabe-Jablonska J, Bienkiewicz W. [Anxiety disorders in the fourth edition of the classification of mental disorders prepared by the American Psychiatric Association: diagnostic and statistical manual of mental disorders (DMS-IV -- options book]. Psychiatr Pol. 1994 Mar-Apr;28(2):255-68. Polish.
PMID: 8208869
responsible party type: Principal Investigator
investigator affiliation: MD Equation
investigator full name: Cecilia Young
investigator title: Founder
mesh term: Intellectual Disability
sharing ipd: No