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Clinical Trials/NCT03234231
NCT03234231UnknownNot Applicable

Supervised Toothbrushing Programme and Oral Health Education for Intellectual Disabled Students: A Cluster Randomised Controlled Trial

MD Equation0 sites602 target enrollmentStarted: May 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
602
Primary Endpoint
Gingivitis score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
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

Eligibility Criteria

Ages
6 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Control Group

No Intervention

This group receive nothing during the study period.

Intervention Group

Experimental

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: 3-month supervised tooth brushing programme (Behavioral)

Intervention Group

Experimental

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: oral health education talk (Behavioral)

Outcomes

Primary Outcomes

Gingivitis score

Time Frame: A study period of 3 months

Measuring the change of oral conditions of the students

Secondary Outcomes

  • Plaque score(A study period of 3 months)

Investigators

Sponsor
MD Equation
Sponsor Class
Industry
Responsible Party
Principal Investigator
Principal Investigator

Cecilia Young

Founder

MD Equation

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