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Supervised Brushing Programme for Intellectual Disabled Students

NCT ID: NCT03234231

Last Updated: 2018-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

602 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Oral Health Intellectual Disability Randomized Controlled Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized controlled trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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

Study Groups

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Control Group

This group receive nothing during the study period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

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

Group Type EXPERIMENTAL

3-month supervised tooth brushing programme

Intervention Type BEHAVIORAL

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.

oral health education talk

Intervention Type BEHAVIORAL

It is conducted by a dentist, while written materials will be delivered to the students and their carers.

Interventions

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3-month supervised tooth brushing programme

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

oral health education talk

It is conducted by a dentist, while written materials will be delivered to the students and their carers.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MD Equation

INDUSTRY

Sponsor Role lead

Responsible Party

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Cecilia Young

Founder

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cecilia Young, BDS(HK),MPH

Role: PRINCIPAL_INVESTIGATOR

MD Equation

Central Contacts

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Cecilia Young, BDS(HK),MPH

Role: CONTACT

Phone: (+852) 23618684

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 20500706 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20568423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14650557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8208869 (View on PubMed)

Related Links

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http://www.hkjcpmh.org.hk/uploads/books/pdf/178344fa63dc4fa193b998268e345219.pdf

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)

Other Identifiers

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HM01

Identifier Type: -

Identifier Source: org_study_id