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
About this trial
This is an interventional health services research trial for Oral Health
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.
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
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)
Learn more about this trial
Supervised Brushing Programme for Intellectual Disabled Students
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