Oral HealthNCT03234231
Supervised Brushing Programme for Intellectual Disabled Students
A study testing 3-month supervised tooth brushing programme and oral health education talk in people with Oral Health and Intellectual Disability, run by MD Equation.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Oral Health, Intellectual Disability, Randomized Controlled Trial
- What is being tested?
- 3-month supervised tooth brushing programme and oral health education talk
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Mild and moderate grade intellectual disabled students in special schools.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- 3-month supervised tooth brushing programme, oral health education talk
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-month supervised tooth brushing programmeBehavioural
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 talkBehavioural
It is conducted by a dentist, while written materials will be delivered to the students and their carers.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: 3-month supervised tooth brushing programme; Behavioral: oral health education talk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingivitis score
Measuring the change of oral conditions of the students
Measured: A study period of 3 months
Secondary outcomes (1)
Plaque score
Measuring the change of oral conditions of the students
Measured: A study period of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start1 May 2018 (estimated)
- Primary completion30 Nov 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 602 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MD Equation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Cecilia Young, MD Equation
- Investigators
- Cecilia Young, BDS(HK),MPH, Principal investigator, MD Equation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234231
- Sponsor's protocol ID
- HM01
- Status last verified
- Mar 2018
- First submitted
- 25 Jul 2017
- Last updated
- 30 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20500706Stefanovska 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.
PubMed 20568423Shyama 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.
PubMed 14650557Rabe-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.
PubMed 8208869
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Toothbrushing Programme and Oral Health Education for Intellectual Disabled Students: A Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03234231
- Acronym / sponsor ID
- HM01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 602 participants (estimated)
- Lead sponsor
- MD EquationIndustry (pharma, biotech, devices)
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This group receive nothing during the study period. |
| Intervention Group | Experimental | Behavioral: 3-month supervised tooth brushing programme, Behavioral: oral health education talkA 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 |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Mild and moderate grade intellectual disabled students in special schools.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-month supervised tooth brushing programmeOne 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. | Behavioural | Intervention Group |
| oral health education talkIt is conducted by a dentist, while written materials will be delivered to the students and their carers. | Behavioural | Intervention Group |
Primary outcome
Gingivitis score
Time frame: A study period of 3 months
Measuring the change of oral conditions of the students
1 secondary outcome
Plaque score
Time frame: A study period of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Background: PubMed 20500706Anders 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.
- Background: PubMed 20568423Stefanovska 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.
- Background: PubMed 14650557Shyama 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.
- Background: PubMed 8208869Rabe-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.
- 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)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilia Young, BDS(HK),MPH principal investigator
MD Equation
Questions about this trial
What is this clinical trial studying?
A study testing 3-month supervised tooth brushing programme and oral health education talk in people with Oral Health and Intellectual Disability, run by MD Equation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecilia Young, BDS(HK),MPH ((+852) 23618684, ceciliatyp@yahoo.com.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingivitis score (time frame: A study period of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03234231, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018.