Oral Health TrainingNCT06933342
ASD and Habituation to Dental Examination
A study testing Habituation to dental examination and Preparations at home in people with Oral Health Training and Habituation, run by Oral Health Center of Expertise Rogaland, Norway at 2 sites in Norway.
Trial summary
The goal of this effectiveness trial is to investigate if an integrated dental habituation programme can enhance acceptance of a clinical dental examination in children (aged 5-8 years) with autism spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Oral Health Training, Habituation, Autism Spectrum Disorder
- What is being tested?
- Habituation to dental examination and Preparations at home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Jun 2025to Feb 2027
- 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children living in the counties Rogaland or Vestland, Norway
- English or Norwegian speaking
- Have not been able to complete a clinical dental examination at the local dental clinic
- Has an autism spectrum diagnosis (reported by parents/guardians)
Who cannot join
- Children not living in the counties Rogaland or Vestland, Norway
- Does not speak English or Norwegian
- Have completed a dental examination at the local dental clinic
- Have other severe developmental cognitive disabilites (in addition to an autism spectrum diagnosis) (reported by parents/guardians)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
The public dental health service Vestland Norway
Bergen, Vestland, 5008
Andrzej Adam Pawlowski, DDS, 51506854, andrzej.adam.pawlowski@throg.no
Maren Lillehaug Agdal, DDS, PhD, maren.gry.lillehaug.agdal@vlfk.no
- Recruiting
Oral health centre of Expertise Rogaland
Stavanger, Rogaland, 4016
Andrzej Adam Pawlowski, DDS, Andrzej.adam.pawlowski@throg.no
Lene Elisabeth Myhren, PhD, 004751506848, lene.elisabeth.myhren@throg.no
About this study
Official title: Evaluating an Integrated Habituation Programme for Enhancing Dental Examination Acceptance in Children With Autism Spectrum Disorder: An Effectiveness Trial
The goal of this effectiveness trial is to investigate if an integrated dental habituation programme can enhance acceptance of a clinical dental examination in children (aged 5-8 years) with autism spectrum disorder (ASD).
The main questions it aims to answer are:
Read more
- Can a dental habituation programme performed by trained dental hygienists increase the acceptance of a clinical dental examination in children with ASD?
- Is a dental habituation programme for children with ASD more effective compared to home preparation using visual aids performed by parents/guardians in increasing the acceptance of a clinical dental examination in children with ASD?
The study participants will be randomly assigned to either the habituation group (intervention) or the home preparation group (augmented control) to investigate the effectiveness in increasing acceptance and cooperation of a clinical dental examination.
Read the detailed description
BACKGROUND Autism Spectrum Disorder (ASD) is a developmental disorder characterized by deviations in language, communication, social interaction, and a restricted and repetitive pattern of activities and interests. Good oral health is crucial for life satisfaction and impacts general health, nutrition, appearance, and communication. Several studies have shown that children with ASD often face challenges during oral examinations and dental treatments. Increased stress and anxiety in these patients also make dental treatment challenging for caregivers and the dental team. Various studies have demonstrated that communication aids, such as visual tools (pictures, books, films), and familiarization techniques (e.g., tell-show-do), can reduce stress and increase cooperation during dental examinations. Studies indicate that knowledge about ASD among healthcare professionals is limited. Despite continuous improvements, there is significant variation in knowledge levels across different age groups and professional backgrounds. A lack of knowledge and confidence in their skills among healthcare professionals can result in poorer healthcare services for children with ASD. Sufficient knowledge and early intervention are essential for achieving positive outcomes for this patient group.
METHODS
Design and Procedures:
To address this challenge and enable more dental examinations at local clinics, the investigators have developed a training program for dental personnel. The course, developed by pediatric dentists, was presented to a resource group consisting of a psychologist, a dental hygienist, dentists, a researcher, and a parent of a child with ASD. Adaptations were made based on feedback from the resource group. The course includes both theoretical and practical content, focusing on ASD characteristics, communication techniques, and tools specific to this patient group to increase cooperation and the completion of clinical dental examinations. During the course, dental personnel will be trained in a habituation program to provide a gradual and structured approach to dental examinations, minimizing unwanted behavior and reducing perceived stress in the child, parent, and dental practitioner. To the effectiveness of the integrated habituation program will be evaluated in a randomized controlled trial. The intervention will last for 5 weeks, with one habituation session each week. The habituation sessions will be performed at selected dental clinics. Clinics will be selected based on geographical location, and on the affiliation of the dental hygienist participating in the study.
Participants will be recruited from two counties in western Norway (Rogaland and Vestland) and randomly assigned to either the intervention group or an augmented control group. The augmented control group will receive a toolbox with visual aids for home preparation before a dental appointment, similar to the intervention group. Participation will be based on written informed consent provided by the parents og caregivers of the children.
Measurements:
The effects of the habituation program will be assessed based on the successful completion of a clinical dental examination. Additionally, changes in cooperation (using the Frankl scale) during each session will be recorded. Parents will be asked to fill out a mapping form at baseline, and clinical data from patient journals will be collected. Child stress will be measured using the Wong Baker FACES® scale. In addition, following the intervention, both parents and dental hygieneists will be invited to an interview to share their experiences as part of the evaluation of the study.
Power and Sample Size:
The estimation of sample size is based on a binary logistic model with a random effect factor. 1000 Monte Carlo simulations indicate that 225 children are needed to provide satisfactory power, given that the difference in the probability of success is not less than 0.2. However, there is uncertainty associated with the calculations since previous studies, which formed the basis for this calculation, differ from this study in several ways (e.g., different age and setting, different steps in the habituation program). It was calculated that at least 6 dental hygienists are needed to participate in the study and perform the habituation program.
Data Analysis:
The statistical software package SPSS (IBM) will be used to analyze quantitative data such as questionaire data, Frankl scale data, and clinical data from patient journals. The analyses will include descriptive statistics and statistical tests to identify changes and differences in the study variables within and between the intervention and control groups (e.g., t-tests, mixed-effects models). It is hypothesized that the use of the habituation program will lead to increased cooperation and completion of clinical dental examinations, and a reduction in child and parental stress in this setting. Regression analysis will be employed to investigate associations between study variables while adjusting for potential covariates. NVivo (Alfasoft) will be used to analyze additional qualitative data from patient journals.
- Conditions
- Oral Health Training, Habituation, Autism Spectrum Disorder
- Being tested
- Habituation to dental examination, Preparations at home
- Keywords
- autism spectrum disorder, ASD, Dental examination, Dental habituation programme, Habituation, Oral health training
- Medical subject headings
- Substance-Related Disorders, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habituation to dental examinationBehavioural
The habituation will be performed by dental hygenists working in the public dental service in Rogaland or Vestland counties. The dental hygenists have completed a 2-day educational course consisting of both theoretical and practical information specifically adressing dental examination of children with autism spectrum disorder. The habituation will be done at the dental office.
The intervention consists of five structured habituation sessions with the trained dental hygienist where the different elements of a clinical dental examination will be introduced stepwise in a controlled manner. Parents/guardians will also receive a "toolbox" with visual aids with instructions for use during home preparations prior to the habituation sessions.
Preparations at homeBehavioural
Participants in the augmented control group will receive a "toolbox" with visual aids. The parents/guardians of these participants will receive written information on how to use these tools at home to prepare for a clinical dental examination.
| Study group | Role | What they receive |
|---|---|---|
| At home preparation | Other | The control group will be an augmented control group. The participants in this group will receive the same "toolbox" with visual aids and written instructions on how to use the toolbox as the intervention group, for preparations at home prior to the dental appointment Receives: Behavioral: Preparations at home |
| Habituation group | Experimental | Participants in the experimental group will receive five structured habituation sessions in a dental clinic with a trained dental hygienist. Parents/guardians will receive a "toolbox" with visual aids and instructions for use at home preparations prior to the habituation sessions. Receives: Behavioral: Habituation to dental examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of a clinical dental examination with good cooperation
The dental examination has been divided into several steps (i.e., sitting in the chair, accepting examination with dental mirror, accepting light from the lamp, examination with probe). The primary objective will be completion of a clinical dental examination (examination with mirror and probe) with good cooperation. After 5 weeks (either with home preparation or habituation sessions) a blinded dental personell (untrained) will do a clinical dental examination (treatment as usual). Cooperation will be measured using the Frankl scale, reported by the parents/guardians for each step in the dental examination.
Measured: 6 weeks after the first habituation session/home preparation
Secondary outcomes (2)
Changes in child stress measured by Wong-Baker FACES pain rating scale
Changes in child stress will be measured by Wong-Baker FACES pain rating scale. The children will be asked to indicate how they feel by pointing on one of the faces that best describe how they feel. If the child is not capable of performing this task, the parent/guardian will be asked to indicate on the scale how they perceive their child to feel at that moment. Children in the intervention group will be asked to do this at the first habituation session and at the post-test (approx. 6 weeks later). Children in the control group will only perform the rating once, at the post-test.
Measured: At session 1, (only intervention group), after 6 weeks (intervention and control group)
Changes in cooperation assessed by Frankl scale
For the intervention group, cooperation during each habituation sessions will be monitored using the Frankl scale. Parents/guardians will be asked to fill out the form.
Measured: Once per week for 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Health TrainingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic randomized controlled trial will be employed to assess the effectiveness of a habituation program for children with autism spectrum disorders to enhance cooperation between the child and the dental hygienist and to enable a dental examination at a local dental clinic. Children will be assigned to either a habituation group (five habituation sessions) or to a control group receiving a "toolbox" with visual aids for preaparations at home.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oral Health Center of Expertise Rogaland, Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, The public dental health service Vestland Norway, Oral Health Centre of Expertise in Western Norway, The public dental service in Trøndelag, Norway, The public dental health care in Rogaland, Norway
- Responsible party
- Sponsor
- Investigators
- Lene Elisabeth Myhren, PhD, Principal investigator, Oral health centre of expertise - Rogaland, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933342
- Sponsor's protocol ID
- OralHealthRogaland
- Status last verified
- Oct 2026
- First submitted
- 10 Mar 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD from this study will not be shared with researchers outside the project group. This is emphasized in the information- and consent form that iwll be handed out to the participants (their parents/guardians) prior to data collection.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an Integrated Habituation Programme for Enhancing Dental Examination Acceptance in Children With Autism Spectrum Disorder: An Effectiveness Trial
- ClinicalTrials.gov ID
- NCT06933342
- Acronym / sponsor ID
- OralHealthRogaland
- Conditions
- Oral Health Training, Habituation, Autism Spectrum Disorder
- Keywords
- autism spectrum disorder, ASD, Dental examination, Dental habituation programme, Habituation, Oral health training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Oral Health Center of Expertise Rogaland, NorwayUniversity, hospital or other
- Collaborators
- University of Oslo, The public dental health service Vestland Norway, Oral Health Centre of Expertise in Western Norway, The public dental service in Trøndelag, Norway, The public dental health care in Rogaland, Norway
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 18 Apr 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.
The goal of this effectiveness trial is to investigate if an integrated dental habituation programme can enhance acceptance of a clinical dental examination in children (aged 5-8 years) with autism spectrum disorder (ASD).
The main questions it aims to answer are:
- Can a dental habituation programme performed by trained dental hygienists increase the acceptance of a clinical dental examination in children with ASD?
- Is a dental habituation programme for children with ASD more effective compared to home preparation using visual aids performed by parents/guardians in increasing the acceptance of a clinical dental examination in children with ASD?
The study participants will be randomly assigned to either the habituation group (intervention) or the home preparation group (augmented control) to investigate the effectiveness in increasing acceptance and cooperation of a clinical dental examination.
Detailed description
BACKGROUND Autism Spectrum Disorder (ASD) is a developmental disorder characterized by deviations in language, communication, social interaction, and a restricted and repetitive pattern of activities and interests. Good oral health is crucial for life satisfaction and impacts general health, nutrition, appearance, and communication. Several studies have shown that children with ASD often face challenges during oral examinations and dental treatments. Increased stress and anxiety in these patients also make dental treatment challenging for caregivers and the dental team. Various studies have demonstrated that communication aids, such as visual tools (pictures, books, films), and familiarization techniques (e.g., tell-show-do), can reduce stress and increase cooperation during dental examinations. Studies indicate that knowledge about ASD among healthcare professionals is limited. Despite continuous improvements, there is significant variation in knowledge levels across different age groups and professional backgrounds. A lack of knowledge and confidence in their skills among healthcare professionals can result in poorer healthcare services for children with ASD. Sufficient knowledge and early intervention are essential for achieving positive outcomes for this patient group.
METHODS
Design and Procedures:
To address this challenge and enable more dental examinations at local clinics, the investigators have developed a training program for dental personnel. The course, developed by pediatric dentists, was presented to a resource group consisting of a psychologist, a dental hygienist, dentists, a researcher, and a parent of a child with ASD. Adaptations were made based on feedback from the resource group. The course includes both theoretical and practical content, focusing on ASD characteristics, communication techniques, and tools specific to this patient group to increase cooperation and the completion of clinical dental examinations. During the course, dental personnel will be trained in a habituation program to provide a gradual and structured approach to dental examinations, minimizing unwanted behavior and reducing perceived stress in the child, parent, and dental practitioner. To the effectiveness of the integrated habituation program will be evaluated in a randomized controlled trial. The intervention will last for 5 weeks, with one habituation session each week. The habituation sessions will be performed at selected dental clinics. Clinics will be selected based on geographical location, and on the affiliation of the dental hygienist participating in the study.
Participants will be recruited from two counties in western Norway (Rogaland and Vestland) and randomly assigned to either the intervention group or an augmented control group. The augmented control group will receive a toolbox with visual aids for home preparation before a dental appointment, similar to the intervention group. Participation will be based on written informed consent provided by the parents og caregivers of the children.
Measurements:
The effects of the habituation program will be assessed based on the successful completion of a clinical dental examination. Additionally, changes in cooperation (using the Frankl scale) during each session will be recorded. Parents will be asked to fill out a mapping form at baseline, and clinical data from patient journals will be collected. Child stress will be measured using the Wong Baker FACES® scale. In addition, following the intervention, both parents and dental hygieneists will be invited to an interview to share their experiences as part of the evaluation of the study.
Power and Sample Size:
The estimation of sample size is based on a binary logistic model with a random effect factor. 1000 Monte Carlo simulations indicate that 225 children are needed to provide satisfactory power, given that the difference in the probability of success is not less than 0.2. However, there is uncertainty associated with the calculations since previous studies, which formed the basis for this calculation, differ from this study in several ways (e.g., different age and setting, different steps in the habituation program). It was calculated that at least 6 dental hygienists are needed to participate in the study and perform the habituation program.
Data Analysis:
The statistical software package SPSS (IBM) will be used to analyze quantitative data such as questionaire data, Frankl scale data, and clinical data from patient journals. The analyses will include descriptive statistics and statistical tests to identify changes and differences in the study variables within and between the intervention and control groups (e.g., t-tests, mixed-effects models). It is hypothesized that the use of the habituation program will lead to increased cooperation and completion of clinical dental examinations, and a reduction in child and parental stress in this setting. Regression analysis will be employed to investigate associations between study variables while adjusting for potential covariates. NVivo (Alfasoft) will be used to analyze additional qualitative data from patient journals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A pragmatic randomized controlled trial will be employed to assess the effectiveness of a habituation program for children with autism spectrum disorders to enhance cooperation between the child and the dental hygienist and to enable a dental examination at a local dental clinic. Children will be assigned to either a habituation group (five habituation sessions) or to a control group receiving a "toolbox" with visual aids for preaparations at home.
| Arm | Type | Receives |
|---|---|---|
| At home preparation | Other | Behavioral: Preparations at homeThe control group will be an augmented control group. The participants in this group will receive the same "toolbox" with visual aids and written instructions on how to use the toolbox as the intervention group, for preparations at home prior to the dental appointment |
| Habituation group | Experimental | Behavioral: Habituation to dental examinationParticipants in the experimental group will receive five structured habituation sessions in a dental clinic with a trained dental hygienist. Parents/guardians will receive a "toolbox" with visual aids and instructions for use at home preparations prior to the habituation sessions. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children living in the counties Rogaland or Vestland, Norway
- English or Norwegian speaking
- Have not been able to complete a clinical dental examination at the local dental clinic
- Has an autism spectrum diagnosis (reported by parents/guardians)
Key exclusion criteria (4 listed)
- Children not living in the counties Rogaland or Vestland, Norway
- Does not speak English or Norwegian
- Have completed a dental examination at the local dental clinic
- Have other severe developmental cognitive disabilites (in addition to an autism spectrum diagnosis) (reported by parents/guardians)
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 |
|---|---|---|
| Habituation to dental examinationThe habituation will be performed by dental hygenists working in the public dental service in Rogaland or Vestland counties. The dental hygenists have completed a 2-day educational course consisting of both theoretical and practical information specifically adressing dental examination of children with autism spectrum disorder. The habituation will be done at the dental office. The intervention consists of five structured habituation sessions with the trained dental hygienist where the different elements of a clinical dental examination will be introduced stepwise in a controlled manner. Parents/guardians will also receive a "toolbox" with visual aids with instructions for use during home preparations prior to the habituation sessions. | Behavioural | Habituation group |
| Preparations at homeParticipants in the augmented control group will receive a "toolbox" with visual aids. The parents/guardians of these participants will receive written information on how to use these tools at home to prepare for a clinical dental examination. | Behavioural | At home preparation |
Primary outcome
Completion of a clinical dental examination with good cooperation
Time frame: 6 weeks after the first habituation session/home preparation
The dental examination has been divided into several steps (i.e., sitting in the chair, accepting examination with dental mirror, accepting light from the lamp, examination with probe). The primary objective will be completion of a clinical dental examination (examination with mirror and probe) with good cooperation. After 5 weeks (either with home preparation or habituation sessions) a blinded dental personell (untrained) will do a clinical dental examination (treatment as usual). Cooperation will be measured using the Frankl scale, reported by the parents/guardians for each step in the dental examination.
2 secondary outcomes
Changes in child stress measured by Wong-Baker FACES pain rating scale
Time frame: At session 1, (only intervention group), after 6 weeks (intervention and control group)
Changes in cooperation assessed by Frankl scale
Time frame: Once per week for 5 weeks
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 5 Oct 2026.
- Individual participant dataSharing planned: No. IPD from this study will not be shared with researchers outside the project group. This is emphasized in the information- and consent form that iwll be handed out to the participants (their parents/guardians) prior to data collection.
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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.
Lene Elisabeth Myhren, PhD principal investigator
Oral health centre of expertise - Rogaland, Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Habituation to dental examination and Preparations at home in people with Oral Health Training and Habituation, run by Oral Health Center of Expertise Rogaland, Norway at 2 sites in Norway.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Contact Andrzej Adam Pawlowski, DDS, Pediatric dentist (+4751506854, andrzej.adam.pawlowski@throg.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of a clinical dental examination with good cooperation (time frame: 6 weeks after the first habituation session/home preparation). 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 5 Oct 2026.