- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03234231
Supervised Brushing Programme for Intellectual Disabled Students
29. marts 2018 opdateret af: Cecilia Young, MD Equation
Supervised Toothbrushing Programme and Oral Health Education for Intellectual Disabled Students: A Cluster Randomised Controlled Trial
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.
Studieoversigt
Status
Ukendt
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
602
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
6 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Control Group
This group receive nothing during the study period.
|
|
|
Eksperimentel: 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
|
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.
It is conducted by a dentist, while written materials will be delivered to the students and their carers.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Gingivitis score
Tidsramme: A study period of 3 months
|
Measuring the change of oral conditions of the students
|
A study period of 3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Plaque score
Tidsramme: A study period of 3 months
|
Measuring the change of oral conditions of the students
|
A study period of 3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Cecilia Young, BDS(HK),MPH, MD Equation
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. maj 2018
Primær færdiggørelse (Forventet)
30. november 2018
Studieafslutning (Forventet)
31. december 2018
Datoer for studieregistrering
Først indsendt
25. juli 2017
Først indsendt, der opfyldte QC-kriterier
28. juli 2017
Først opslået (Faktiske)
31. juli 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. marts 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. marts 2018
Sidst verificeret
1. marts 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HM01
Plan for individuelle deltagerdata (IPD)
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