Taste acceptance of fluoride varnish on autistic patients

Quantitative analysis on the taste perception of different flavoured fluoride varnish on patients with autistic spectrum disorder (ASD)

Registry ID
ISRCTN16862566
Source registry
ISRCTN
Status
No longer recruiting
Study type
INTERVENTIONAL
Sponsor
Abertawe Bro Morgannwg University Health Board
Enrollment
60
Start date
2019-06-01
Completion date
2023-12-23
Last update
2026-08-17

Conditions

Summary

Preventive dental care in autistic children

Detailed description

The taste acceptance of the fluoride varnish compounds Duraphat® (Colgate, New York, NY, USA), Profluorid® (VOCO GmbH, Cuxhaven, Germany), and MI varnish® (GC Europe N.V., Leuven, Belgium) are investigated. The three varnish preparations were presented without labels because of their similar application methods. The Frankl behavior rating scale was used to measure the subjects’ non-verbal behavior (objective data) as a measure of taste acceptance of three different fluoride varnishes, and a three-point smiley rating scale (subjective data) will be used to assess the subject’s acceptance of the preparation. The intervention consists of three phases preceded by an initial phase where the procedure is explained and demonstrated to children in a standard dialogue by the project leader (X) using the Tell-Show-Do technique for behavior management. Later subjects are instructed and guided on how to indicate the taste of the FV preparation on the three-point smiley rating scale, which includes faces with a laughing, crying or neutral facial expression. The non-verbal behavior of each of the subjects will be assessed before (phase I) and immediately after the FV application (phase II) by using the Frankl Behavior Rating Scale, ranging from ‘definitely negative’ to ‘definitely positive’. The nonverbal behavior of each subject before fluoride varnish application will be evaluated by the principal investigator (X) who is blinded to the allocation of participants. The dental nurse will assign the participants to the three FV interventions randomly with an allocation ratio of 1:1:1. Simple random allocation is used where each participant is randomly allocated to one of the three groups as they arrive. This method ensures that each participant has an equal chance of being assigned to any of the groups and concealed until the exact moment of assignment. Twenty participants are included in each of the three groups to allow for comparison of the three flavored fluoride varnishes. The

Interventions

Inclusion criteria

1. 3-15-year-old autistic children 2. Children with previous or current caries experience who were indicated for fluoride varnish application based on caries risk assessment

Exclusion criteria

1. Coexistence of diseases that may affect taste assessment (type 1 diabetes, infectious diseases 2. 2. Requiring antibiotic therapy, neoplastic diseases) 3. Oral thrush and injuries of the oral mucosa 4. Ulcerative gingival stomatitis 5. Lack of informed consent 6. Voluntary withdrawal of the parent or legal guardian at any stage of the procedure 7. Previous hospital admission for uncontrolled asthma 8. History of dental care provided in sedation or general anesthesia 9. Known sensitivity to colophony (Duraphat®, Profluorid®) 10. Milk protein or hydroxybenzoate allergy (MI varnish®)

Locations

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