Oral HealthNCT06855693
Involving Parents to Improve Tooth Brushing for Autistic Children.
A study testing Delivering better oral health: an evidence-based toolkit for prevention and Mini Mouth Care Matters guide for special Education Settings in people with Oral Health, run by Sussex Community NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Parents of autistic children have reported a lack of understanding by oral health care staff around delivery of oral health preventive habits for their children. This study aims to investigate if oral healthcare training utilising the Mini Mouth Care Matters (MCM) programme designed for Special Education Settings… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Health
- What is being tested?
- Delivering better oral health: an evidence-based toolkit for prevention and Mini Mouth Care Matters guide for special Education Settings
- 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
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jan 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parent/Carer of an autistic child aged between 3 and 15 years Parent/Carer of an autistic child attending a Special Education Setting Parent/Carer with capacity to provide consent
Who cannot join
- Parent/Carer that cannot adequately understand verbal explanations or information written in English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sussex Community NHS Foundation Trust
Brighton, East Sussex, BN2 3EW
About this study
Official title: Oral Health Care Guidance to Enhance Parent Confidence and Ability to Improve Toothbrushing Performance for Autistic Children
Parents of autistic children have reported a lack of understanding by oral health care staff around delivery of oral health preventive habits for their children.
This study aims to investigate if oral healthcare training utilising the Mini Mouth Care Matters (MCM) programme designed for Special Education Settings (SES) enhances parent confidence in their ability to influence their child's oral health, increases toothbrushing episodes and reduces challenging toothbrushing behaviour of autistic children.
Read more
The participants of this study will be parents of children who have a confirmed professional diagnosis of Autistic Spectrum Disorder. Parents will be recruited via healthcare professionals who provide oral health promotion within SES. Special Education Settings will be randomised into one of two groups. Group one will receive 'delivering better oral health' advice. Group two will receive the MCM user intervention guide for oral healthcare.
A maximum of 30 parents will be recruited into each intervention arm. A maximum of 60 parents will be recruited to the study.
Read the detailed description
Description of the Intervention:
The first national dental health survey for special schools in England shows that:
- At ages 5 and 12, compared to previous surveys in mainstream education, the proportion of children in special education with substantial plaque visible is almost double.
- Children aged 5 in special schools were twice as likely to have had one or more teeth extracted.
The Office of the Chief Dental Officer Special Education Settings Team has developed resources which focus on prevention for better oral health for children with learning disabilities, autism or both. Resources include information and tips to help parents and carers with frequent concerns such as: Am I using the right toothpaste? Have I got the right toothbrush? Is the environment right? Am I doing it right? The resources are available on the HEE hub e- Learning for Healthcare (e-LfH) through the link Mini Mouth Care Matters (Mini MCM) Special Education Settings (SES).
The participants of this study will be parents recruited through contact with Special Educational Settings designated for oral health promotion activity from the Special Care Dental Service. Parents invited to be included in the study will be parents of children aged 3 to 15 years, with a confirmed professional diagnosis of Autistic Spectrum Disorder.
Participants will be divided by schools into two groups of parents. Each group will be randomly assigned to either the mini MCM intervention or the 'Delivering Better Oral Health' intervention. A written consent form will be provided for participants. After receiving the information regarding the study participants will be given a minimum of 48 hours to consider the information supplied before deciding whether they would like to participate. Sample size calculation based on the measure of toothbrushing performance indicates a minimum requirement of 24 participants in each group. Two groups of 30 parents will be recruited considering that children may be lost to follow-up. Group 1 parents will receive the typical model of oral health education i.e. 'Delivering Better Oral Health' intervention, providing facts about why toothbrushing should occur and advice for their child aligned with the Public Health England and Department of Health document: "Delivering better oral health: an evidence-based toolkit for prevention".
Group 2 parents will be provided with a training session using the resources developed for Mini Mouth Care Matters SES, which include specific strategies to be considered and adopted for children who are resistant to toothbrushing. The training sessions for both groups will be followed up with weekly telephone sessions for three weeks, with the option of a face-to-face visit in place of one or more telephone sessions. Both groups will receive the same Tooth Care Pack containing a selection of toothbrushes and toothpastes.
A baseline of parental attitudes using the Oral Health Behaviours Questionnaire will be recorded.
Occurrence and severity of toothbrushing behaviour problems will be recorded at baseline and at the post training intervention three week follow-up using the 13-step assessment tool identifying steps completed by parents or children, or steps not possible to complete. Parents will also be asked to record time spent toothbrushing.
Results will be analysed to examine any inter- and intra-group differences in toothbrushing behaviour and parent confidence regarding their ability to influence their child's oral health by successfully delivering twice daily toothbrushing episodes for their autistic child.
- Conditions
- Oral Health
- Being tested
- Delivering better oral health: an evidence-based toolkit for prevention, Mini Mouth Care Matters guide for special Education Settings
- Keywords
- oral health, children, autism
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delivering better oral health: an evidence-based toolkit for preventionBehavioural
The PHE Delivering Better Oral Health toolkit has been developed with the support of the 4 UK Chief Dental Officers. This is a general population approach to Oral Hygiene advice and includes the following:
Effective toothbrushing with a fluoride toothpaste is important to support oral health. The physical action of brushing removes plaque, which prevents gingivitis and periodontitis, and the fluoride in toothpaste is effective against tooth decay. The following key messages for the population include when and how to brush, specific habits associated with brushing, and, where necessary, assistance with brushing. There may be adaptations of toothbrushes, such as special grip handles, that are helpful to people who have limited manual dexterity.
Mini Mouth Care Matters guide for special Education SettingsBehavioural
- Oral hygiene guidance from a Clinical standard for autistic children and young people and/or those with a learning disability in special educational settings (Mini Mouth Care Matters Special Education Settings resources.
This is a specific approach to providing Oral Hygiene for children with sensory challenges.
This clinical standard supports the vision of universal access whereby everyone receives quality health services that meet their specific needs.
The clinical standard is designed to be used by all those involved in improving health outcomes and quality of life, including eating, speaking and socialising, for autistic children and young people, and those with a learning disability in England.
It is accompanied by a supporting package of tools, resources, and modules to support the delivery of the oral healthcare assessment (either face to face or remote) and to support teams in the development of complementary tailored mouthcare plans.
| Study group | Role | What they receive |
|---|---|---|
| Delivering better oral health: an evidence-based toolkit for prevention | Experimental | The PHE Delivering Better Oral Health toolkit has been developed with the support of the 4 UK Chief Dental Officers. This is a general population approach to Oral Hygiene advice and includes the following: Effective toothbrushing with a fluoride toothpaste is important to support oral health. The physical action of brushing removes plaque, which prevents gingivitis and periodontitis, and the fluoride in toothpaste is effective against tooth decay. The following key messages for the population include when and how to brush, specific habits associated with brushing, and, where necessary, assistance with brushing. There may be adaptations of toothbrushes, such as special grip handles, that are helpful to people who have limited manual dexterity. Receives: Behavioral: Delivering better oral health: an evidence-based toolkit for prevention |
| Mini Mouth Care Matters guide for special Education Settings | Experimental | Oral hygiene guidance from a Clinical standard for autistic children and young people and/or those with a learning disability in special educational settings (Mini Mouth Care Matters Special Education Settings resources. This is a specific approach to providing Oral Hygiene for children with sensory challenges. This clinical standard supports the vision of universal access whereby everyone receives quality health services that meet their specific needs. The clinical standard is designed to be used by all those involved in improving health outcomes and quality of life, including eating, speaking and socialising, for autistic children and young people, and those with a learning disability in England. It is accompanied by a supporting package of tools, resources, and modules to support the delivery of the oral healthcare assessment (either face to face or remote) and to support teams in the development o Receives: Behavioral: Mini Mouth Care Matters guide for special Education Settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 13-step toothbrushing assessment tool
The 13-step assessment tool identifies steps completed by parents or children, or steps not possible to complete. Parents will also be asked to record time spent toothbrushing.
Measured: baseline and immediately after the intervention
The validated Parental-Caregiver Current Oral Health Behaviours Questionnaire (OHBQ).
The OHBQ has been developed to measure attitudes and beliefs of parents around their child's dental health. A section to capture demographic data, with questions utilised in previous studies, has been incorporated in the questionnaire sheet above the OHBQ to explore oral health inequalities associated with socioeconomic status, which are widely observed in the literature6.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start3 Jan 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sussex Community NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Parry, FDS RCS(Paeds) MDentSci BDS, Principal investigator, Sussex Community NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855693
- Sponsor's protocol ID
- 331171
- Status last verified
- Mar 2025
- First submitted
- 19 Feb 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Care Guidance to Enhance Parent Confidence and Ability to Improve Toothbrushing Performance for Autistic Children
- ClinicalTrials.gov ID
- NCT06855693
- Acronym / sponsor ID
- 331171
- Conditions
- Oral Health
- Keywords
- oral health, children, autism
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sussex Community NHS Foundation TrustUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 4 Mar 2025 (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.
Parents of autistic children have reported a lack of understanding by oral health care staff around delivery of oral health preventive habits for their children.
This study aims to investigate if oral healthcare training utilising the Mini Mouth Care Matters (MCM) programme designed for Special Education Settings (SES) enhances parent confidence in their ability to influence their child's oral health, increases toothbrushing episodes and reduces challenging toothbrushing behaviour of autistic children.
The participants of this study will be parents of children who have a confirmed professional diagnosis of Autistic Spectrum Disorder. Parents will be recruited via healthcare professionals who provide oral health promotion within SES. Special Education Settings will be randomised into one of two groups. Group one will receive 'delivering better oral health' advice. Group two will receive the MCM user intervention guide for oral healthcare.
A maximum of 30 parents will be recruited into each intervention arm. A maximum of 60 parents will be recruited to the study.
Detailed description
Description of the Intervention:
The first national dental health survey for special schools in England shows that:
- At ages 5 and 12, compared to previous surveys in mainstream education, the proportion of children in special education with substantial plaque visible is almost double.
- Children aged 5 in special schools were twice as likely to have had one or more teeth extracted.
The Office of the Chief Dental Officer Special Education Settings Team has developed resources which focus on prevention for better oral health for children with learning disabilities, autism or both. Resources include information and tips to help parents and carers with frequent concerns such as: Am I using the right toothpaste? Have I got the right toothbrush? Is the environment right? Am I doing it right? The resources are available on the HEE hub e- Learning for Healthcare (e-LfH) through the link Mini Mouth Care Matters (Mini MCM) Special Education Settings (SES).
The participants of this study will be parents recruited through contact with Special Educational Settings designated for oral health promotion activity from the Special Care Dental Service. Parents invited to be included in the study will be parents of children aged 3 to 15 years, with a confirmed professional diagnosis of Autistic Spectrum Disorder.
Participants will be divided by schools into two groups of parents. Each group will be randomly assigned to either the mini MCM intervention or the 'Delivering Better Oral Health' intervention. A written consent form will be provided for participants. After receiving the information regarding the study participants will be given a minimum of 48 hours to consider the information supplied before deciding whether they would like to participate. Sample size calculation based on the measure of toothbrushing performance indicates a minimum requirement of 24 participants in each group. Two groups of 30 parents will be recruited considering that children may be lost to follow-up. Group 1 parents will receive the typical model of oral health education i.e. 'Delivering Better Oral Health' intervention, providing facts about why toothbrushing should occur and advice for their child aligned with the Public Health England and Department of Health document: "Delivering better oral health: an evidence-based toolkit for prevention".
Group 2 parents will be provided with a training session using the resources developed for Mini Mouth Care Matters SES, which include specific strategies to be considered and adopted for children who are resistant to toothbrushing. The training sessions for both groups will be followed up with weekly telephone sessions for three weeks, with the option of a face-to-face visit in place of one or more telephone sessions. Both groups will receive the same Tooth Care Pack containing a selection of toothbrushes and toothpastes.
A baseline of parental attitudes using the Oral Health Behaviours Questionnaire will be recorded.
Occurrence and severity of toothbrushing behaviour problems will be recorded at baseline and at the post training intervention three week follow-up using the 13-step assessment tool identifying steps completed by parents or children, or steps not possible to complete. Parents will also be asked to record time spent toothbrushing.
Results will be analysed to examine any inter- and intra-group differences in toothbrushing behaviour and parent confidence regarding their ability to influence their child's oral health by successfully delivering twice daily toothbrushing episodes for their autistic child.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Delivering better oral health: an evidence-based toolkit for prevention | Experimental | Behavioral: Delivering better oral health: an evidence-based toolkit for preventionThe PHE Delivering Better Oral Health toolkit has been developed with the support of the 4 UK Chief Dental Officers. This is a general population approach to Oral Hygiene advice and includes the following: Effective toothbrushing with a fluoride toothpaste is important to support oral health. The physical action of brushing removes plaque, which prevents gingivitis and periodontitis, and the fluoride in toothpaste is effective against tooth decay. The following key messages for the population include when and how to brush, specific habits associated with brushing, and, where necessary, assistance with brushing. There may be adaptations of toothbrushes, such as special grip handles, that are helpful to people who have limited manual dexterity. |
| Mini Mouth Care Matters guide for special Education Settings | Experimental | Behavioral: Mini Mouth Care Matters guide for special Education SettingsOral hygiene guidance from a Clinical standard for autistic children and young people and/or those with a learning disability in special educational settings (Mini Mouth Care Matters Special Education Settings resources. This is a specific approach to providing Oral Hygiene for children with sensory challenges. This clinical standard supports the vision of universal access whereby everyone receives quality health services that meet their specific needs. The clinical standard is designed to be used by all those involved in improving health outcomes and quality of life, including eating, speaking and socialising, for autistic children and young people, and those with a learning disability in England. It is accompanied by a supporting package of tools, resources, and modules to support the delivery of the oral healthcare assessment (either face to face or remote) and to support teams in the development o |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parent/Carer of an autistic child aged between 3 and 15 years Parent/Carer of an autistic child attending a Special Education Setting Parent/Carer with capacity to provide consent
Key exclusion criteria (1 listed)
- Parent/Carer that cannot adequately understand verbal explanations or information written in English
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 |
|---|---|---|
| Delivering better oral health: an evidence-based toolkit for preventionThe PHE Delivering Better Oral Health toolkit has been developed with the support of the 4 UK Chief Dental Officers. This is a general population approach to Oral Hygiene advice and includes the following: Effective toothbrushing with a fluoride toothpaste is important to support oral health. The physical action of brushing removes plaque, which prevents gingivitis and periodontitis, and the fluoride in toothpaste is effective against tooth decay. The following key messages for the population include when and how to brush, specific habits associated with brushing, and, where necessary, assistance with brushing. There may be adaptations of toothbrushes, such as special grip handles, that are helpful to people who have limited manual dexterity. | Behavioural | Delivering better oral health: an evidence-based toolkit for prevention |
| Mini Mouth Care Matters guide for special Education Settings2. Oral hygiene guidance from a Clinical standard for autistic children and young people and/or those with a learning disability in special educational settings (Mini Mouth Care Matters Special Education Settings resources. This is a specific approach to providing Oral Hygiene for children with sensory challenges. This clinical standard supports the vision of universal access whereby everyone receives quality health services that meet their specific needs. The clinical standard is designed to be used by all those involved in improving health outcomes and quality of life, including eating, speaking and socialising, for autistic children and young people, and those with a learning disability in England. It is accompanied by a supporting package of tools, resources, and modules to support the delivery of the oral healthcare assessment (either face to face or remote) and to support teams in the development of complementary tailored mouthcare plans. | Behavioural | Mini Mouth Care Matters guide for special Education Settings |
Primary outcome
The 13-step toothbrushing assessment tool
Time frame: baseline and immediately after the intervention
The 13-step assessment tool identifies steps completed by parents or children, or steps not possible to complete. Parents will also be asked to record time spent toothbrushing.
The validated Parental-Caregiver Current Oral Health Behaviours Questionnaire (OHBQ).
Time frame: baseline
The OHBQ has been developed to measure attitudes and beliefs of parents around their child's dental health. A section to capture demographic data, with questions utilised in previous studies, has been incorporated in the questionnaire sheet above the OHBQ to explore oral health inequalities associated with socioeconomic status, which are widely observed in the literature6.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- 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.
Jennifer Parry, FDS RCS(Paeds) MDentSci BDS principal investigator
Sussex Community NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delivering better oral health: an evidence-based toolkit for prevention and Mini Mouth Care Matters guide for special Education Settings in people with Oral Health, run by Sussex Community NHS Foundation Trust at 1 site in United Kingdom.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 13-step toothbrushing assessment tool (time frame: baseline and immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2025.