ASD and Habituation to Dental Examination (NCT06933342) | Clinical Trial Compass
RecruitingNot Applicable
ASD and Habituation to Dental Examination
Norway225 participantsStarted 2025-06-01
Plain-language 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).
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.
Who can participate
Age range
5 Years – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Completion of a clinical dental examination with good cooperation
Timeframe: 6 weeks after the first habituation session/home preparation
Trial details
NCT IDNCT06933342
SponsorOral Health Center of Expertise Rogaland, Norway