ASD and Habituation to Dental Examination

NCT06933342 | Recruiting

• 1 other identifier: OralHealthRogaland
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 2

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.

Conditions

Oral Health Training; Habituation; Autism Spectrum Disorder

Keywords

autism spectrum disorder; ASD; Dental examination; Dental habituation programme; Habituation; Oral health training

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks after the first habituation session/home preparation

Secondary Outcomes (2)

• Changes in child stress measured by Wong-Baker FACES pain rating scale

  At session 1, (only intervention group), after 6 weeks (intervention and control group)

• Changes in cooperation assessed by Frankl scale

  Once per week for 5 weeks

Other Outcomes (5)

• Mapping questionnaire

  Day 0

• Oral health status measured by DMFT

  Day 0

• Oral hygiene measured by BSI or equivalent measurement

  At the last habituation session (session 5), week 5

Study Arms (2)

At home preparation

OTHER

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

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

Behavioral: Habituation to dental examination

Interventions

Habituation to dental examination 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.

Habituation group

Preparations at home 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.

At home preparation

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oral Health Center of Expertise Rogaland, Norway: lead
• University of Oslo: collaborator
• The public dental health service Vestland Norway: collaborator
• Oral Health Centre of Expertise in Western Norway: collaborator
• The public dental health service Rogaland Norway: collaborator

Study Sites (2)

Oral health centre of Expertise Rogaland

Stavanger, Rogaland, 4016, Norway

RECRUITING

The public dental health service Vestland Norway

Bergen, Vestland, 5008, Norway

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Officials

• Lene Elisabeth Myhren, PhD

  Oral health centre of expertise - Rogaland, Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrzej Adam Pawlowski, DDS, Pediatric dentist

CONTACT

+4751506854; andrzej.adam.pawlowski@throg.no

Lene Elisabeth Myhren, PhD

CONTACT

+4751506848; lene.elisabeth.myhren@throg.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To investigate the effectiveness of the intervention (the habituation program), blinded dental personell (not part of the study otherwise) will perform an oral examination (treatment as usual) on the children approx. 6 weeks following the first habituation/starting preparation at home.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: April 18, 2025
• Study Start: June 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)