ASD and Habituation to Dental Examination
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-8
SponsorOral Health Center of Expertise Rogaland, Norway
About this 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:
* 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Habituation to dental examination
BehavioralThe 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 home
BehavioralParticipants 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.
Treatment groups
225 Participants
are divided into 2 treatment groupsGroup A: At home preparationOther 1 intervention
Group B: Habituation groupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
6 weeks after the first habituation session/home preparationSecondary outcomes
1
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.
Time frame
At session 1, (only intervention group), after 6 weeks (intervention and control group)2
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.
Time frame
Once per week for 5 weeksOther outcomes
1
Mapping questionnaire
At enrollment, parents/guardians will be asked to fill out a questionnaire mapping age, gender, communication skills, sensitivites, previous experience with the public dental service, behavior, oral hygiene habits.
Time frame
Day 02
Oral health status measured by DMFT
To map the oral status of the children and potential unmet needs DMFT will be collected from the patient records. Data collection will be performed by dental personnel with access to the patient record system (OPUS).
Time frame
Day 03
Oral hygiene measured by BSI or equivalent measurement
To map the hygiene of the children, BSI will be assessed either during the last habituation session, if possible, or otherwise collected from the patient records. Data collection will be performed by dental personnel with access to the patient record system (OPUS).
Time frame
At the last habituation session (session 5), week 54
Interview with dental hygienist's to gain their experiences with participating in the study
As part of evaluating the effectiveness of the study and the implementation into a regular dental practice, the dental hygienists who performed the habituation sessions will be interviewed. Their feedback will be important for the future development of the habituation programme and enable the incorporation of the habituation programme into the public dental service. Interviews will be semi-structured focusing on their experiences, motivation for participation, potential or experienced barriers or success factors, development of the habituation programme, implementation
Time frame
Periprocedural, within 2-3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oral Health Center of Expertise Rogaland, Norway
Lead sponsor
University of Oslo
Collaborator
The public dental health service Vestland Norway
Collaborator
Oral Health Centre of Expertise in Western Norway
Collaborator
The public dental service in Trøndelag, Norway
Collaborator
The public dental health care in Rogaland, Norway
Collaborator
Source ClinicalTrials.gov