Parental Perceptions and Acceptance of Silver Diamine Fluoride in Spain and Italy

Acceptability Clinical Trial

— SDF  

Official title:

Comparison of Aesthetic Perception and Acceptability of Silver Diamine Fluoride Staining Between Spanish and Italian Parents.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06384326
• Other study ID #: bagattoni3
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: August 1, 2023

Study information

• Verified date: April 2024
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: August 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Acceptability
• Comparative Study

Locations

Country	Name	City	State
Italy	Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of SDF's overall acceptance between Spanish and Italian parents	Measurement tool: questionnaire. Specific questions focused on the general acceptability of the SDF staining for anterior and posterior teeth. Scores for levels of acceptability were 'unacceptable' (scoring 1), 'somewhat unacceptable' (scoring 2), 'somewhat acceptable' (scoring 3), and 'acceptable' (scoring 4). Higher scores mean a better outcome.	Baseline
Secondary	Comparison of SDF's specific acceptability in different scenarios of child's behavior between Spain and Italy	Measurement tool: questionnaire. Acceptance of SD treatment was evaluated by asking parents if they would allow the treatment to be done on their children in a context of hypothetical scenarios of child cooperation (child cooperative; child upset but could cooperate; child crying; child needs physical restraint; child screaming or kicking; child needs nitrous oxide sedation; child needs oral sedation; child needs general anesthesia). This assessment was carried out separately for anterior and posterior teeth. Scores for acceptance level were 'extremely unlikely' (scoring 1), 'somewhat unlikely' (scoring 2), 'somewhat likely' (scoring 3), and 'very likely' (scoring 4). Higher scores mean a better outcome.	Baseline
Secondary	Parental overall acceptability of SD staining according to demographic background	Measurement tool: questionnaire. Specific questions were strategically formulated to capture a comprehensive range of demographic variables of the participants, including factors such as age, education, and socioeconomic status. The findings from this analysis contribute valuable insights into the nuanced relationship between demographic characteristics and parental attitudes towards SD staining in Spain and Italy.	Baseline