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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03234231
Other study ID # HM01
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 25, 2017
Last updated March 29, 2018
Start date May 1, 2018
Est. completion date December 31, 2018

Study information

Verified date March 2018
Source MD Equation
Contact Cecilia Young, BDS(HK),MPH
Phone (+852) 23618684
Email ceciliatyp@yahoo.com.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 602
Est. completion date December 31, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
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.
oral health education talk
It is conducted by a dentist, while written materials will be delivered to the students and their carers.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
MD Equation

References & Publications (4)

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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Gingivitis score Measuring the change of oral conditions of the students A study period of 3 months
Secondary Plaque score Measuring the change of oral conditions of the students A study period of 3 months
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