ASD and Habituation to Dental Examination

NCT ID: NCT06933342

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

At home preparation

The control group will be an augmented control group. The participants in this group will receive a "toolbox" with visual aids and a dental examination mirror and written instructions on how to use the toolbox for preparations at home prior to the dental appointment

Group Type: OTHER

Preparations at home

Intervention Type: BEHAVIORAL

Participants in the augmented control group will receive a "toolbox" with visual aids and a dental examination mirror. 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.

Habituation group

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, a dental examination mirror and instructions for use at home preparations prior to the habituation sessions.

Group Type: EXPERIMENTAL

Habituation to dental examination

Intervention Type: BEHAVIORAL

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 and a dental examination mirror with instructions for use during home preparations prior to the habituation sessions.

Interventions

Habituation to dental examination

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 and a dental examination mirror with instructions for use during home preparations prior to the habituation sessions.

Intervention Type: BEHAVIORAL

Preparations at home

Participants in the augmented control group will receive a "toolbox" with visual aids and a dental examination mirror. 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

The public dental health service Vestland Norway

UNKNOWN

Sponsor Role: collaborator

Oral Health Centre of Expertise in Western Norway

OTHER

Sponsor Role: collaborator

The public dental health service Rogaland Norway

UNKNOWN

Sponsor Role: collaborator

Oral Health Center of Expertise Rogaland, Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lene Elisabeth Myhren, PhD

Role: PRINCIPAL_INVESTIGATOR

Oral health centre of expertise - Rogaland, Norway

Locations

Oral health centre of Expertise Rogaland

Stavanger, Rogaland, Norway

Site Status: RECRUITING

The public dental health service Vestland Norway

Bergen, Vestland, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Andrzej Adam Pawlowski, DDS, Pediatric dentist

Role: CONTACT

andrzej.adam.pawlowski@throg.no

+4751506854

Lene Elisabeth Myhren, PhD

Role: CONTACT

lene.elisabeth.myhren@throg.no

+4751506848

Facility Contacts

Andrzej Adam Pawlowski, DDS

Role: primary

Andrzej.adam.pawlowski@throg.no

Lene Elisabeth Myhren, PhD

Role: backup

lene.elisabeth.myhren@throg.no

004751506848

Andrzej Adam Pawlowski, DDS

Role: primary

andrzej.adam.pawlowski@throg.no

51506854

Maren Lillehaug Agdal, DDS, PhD

Role: backup

maren.gry.lillehaug.agdal@vlfk.no

Other Identifiers

OralHealthRogaland

Identifier Type: -

Identifier Source: org_study_id