Clinical trial NCT06384326: Parental Perceptions and Acceptance of Silver Diamine Fluoride in Spain and Italy
Official title: Comparison of Aesthetic Perception and Acceptability of Silver Diamine Fluoride Staining Between Spanish and Italian Parents.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Comparative Study
Aesthetic Perception
Acceptability
SDF
Keywords: Silver Diamine Fluoride
Parental perceptions and acceptance
Comparative study
Spain and Italy
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 501
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents awaiting their child\&#39;s dental appointments at three distinct locations: for Italian parents the Unit of Dental Care for Special Needs Patients and Paediatric Dentistry at the University of Bologna, Bologna, Italy, and the Unit of Paediatric Dentistry at the University of Pisa, Pisa, Italy - for Spanish parents the Department of Paediatric Dentistry of the International University of Catalunya (UIC), Barcelona, Spain

Brief summary: Assessing parental aesthetic acceptability of Silver Diamine Fluoride (SDF) staining is crucial for its potential implementation in paediatric dentistry. This study represents the third part of a wider project initially focused on evaluating SDF aesthetic acceptability in Italy, then comparing it between Spanish and Italian parents

Detailed description: The aim of the present study was to compare aesthetic perceptions and acceptance of SDF pigmentation between Spanish and Italian parents, and assess weather acceptability is influenced by location, child's cooperation, or demographic background. A cross-sectional comparative study was conducted among 267 Spanish parents and 234 Italian parents whose children were attending three university dental clinics. A validated Italian version of the questionnaire "Parental perceptions of Silver Diamine Fluoride Dental Color Changes" was implemented. The questionnaire included sets of colored photographs showing both anterior and posterior teeth before and after SD treatment. Respondents were requested to provide their assessments based on the presented visual stimuli.

Eligibility criteria: Inclusion Criteria:

* Spanish and Italian parents, for each group respectively
* Parents of healthy children or children with mild systemic disease. American Society of Anesthesiologists (ASA) status 1-2
* Parents of children under the age of 12 years
* Parents of children with previous caries experience in primary teeth
* Parents who consented to participate

Exclusion Criteria:

* No Spanish and Italian parents, for each group respectively
* Parents of children with ASA status ≥ 3
* Parents of children over the age of 12 years
* Parents of children without previous caries experience in primary teeth
* Parents who no consented to participate

Primary outcomes:
measure: Comparison of SDF's overall acceptance between Spanish and Italian parents
timeFrame: Baseline
Secondary outcomes:
measure: Comparison of SDF's specific acceptability in different scenarios of child's behavior between Spain and Italy
timeFrame: Baseline
measure: Parental overall acceptability of SD staining according to demographic background
timeFrame: Baseline
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile
Study officials:
References: