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Supervised Brushing Programme for Intellectual Disabled Students

Primary Purpose

Oral Health, Intellectual Disability, Randomized Controlled Trial

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3-month supervised tooth brushing programme
oral health education talk
Sponsored by
MD Equation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Oral Health

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mild and moderate grade intellectual disabled students in special schools.

Exclusion Criteria:

  • 1. Those students who have simultaneously joined other oral health programme during the study period.
  • 2. Those students with the presence of conditions rendering a need of antibiotic prophylaxis prior to periodontal examination e.g. rheumatic heart disease.
  • 3. Uncooperative students that oral examination is not possible.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control Group

    Intervention Group

    Arm Description

    This group receive nothing during the study period.

    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

    Outcomes

    Primary Outcome Measures

    Gingivitis score
    Measuring the change of oral conditions of the students

    Secondary Outcome Measures

    Plaque score
    Measuring the change of oral conditions of the students

    Full Information

    First Posted
    July 25, 2017
    Last Updated
    March 29, 2018
    Sponsor
    MD Equation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03234231
    Brief Title
    Supervised Brushing Programme for Intellectual Disabled Students
    Official Title
    Supervised Toothbrushing Programme and Oral Health Education for Intellectual Disabled Students: A Cluster Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2018 (Anticipated)
    Primary Completion Date
    November 30, 2018 (Anticipated)
    Study Completion Date
    December 31, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    MD Equation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Health, Intellectual Disability, Randomized Controlled Trial

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Cluster randomized controlled trial
    Masking
    InvestigatorOutcomes 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
    Allocation
    Randomized
    Enrollment
    602 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    This group receive nothing during the study period.
    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm 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(s)
    3-month supervised tooth brushing programme
    Intervention 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    oral health education talk
    Intervention Description
    It is conducted by a dentist, while written materials will be delivered to the students and their carers.
    Primary Outcome Measure Information:
    Title
    Gingivitis score
    Description
    Measuring the change of oral conditions of the students
    Time Frame
    A study period of 3 months
    Secondary Outcome Measure Information:
    Title
    Plaque score
    Description
    Measuring the change of oral conditions of the students
    Time Frame
    A study period of 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Mild and moderate grade intellectual disabled students in special schools. Exclusion Criteria: 1. Those students who have simultaneously joined other oral health programme during the study period. 2. Those students with the presence of conditions rendering a need of antibiotic prophylaxis prior to periodontal examination e.g. rheumatic heart disease. 3. Uncooperative students that oral examination is not possible.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cecilia Young, BDS(HK),MPH
    Phone
    (+852) 23618684
    Email
    ceciliatyp@yahoo.com.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cecilia Young, BDS(HK),MPH
    Organizational Affiliation
    MD Equation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20500706
    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.
    Results Reference
    background
    PubMed Identifier
    20568423
    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.
    Results Reference
    background
    PubMed Identifier
    14650557
    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.
    Results Reference
    background
    PubMed Identifier
    8208869
    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.
    Results Reference
    background
    Links:
    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)

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