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

NCT06384326 | Completed

• 1 other identifier: bagattoni3
• Study Type: observational
• Target: 501
• Locations: 1 country
• Sites: 1

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

Conditions

Comparative Study; Aesthetic Perception; Acceptability; SDF

Keywords

Silver Diamine Fluoride; Parental perceptions and acceptance; Comparative study; Spain and Italy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison of SDF's specific acceptability in different scenarios of child's behavior between Spain and Italy

  Baseline

• Parental overall acceptability of SD staining according to demographic background

  Baseline

Study Arms (2)

Spanish parents

Spanish parents were recruited at the Department of Paediatric Dentistry of UIC between March 2023 and July 2023, accomplishing the second phase of the survey.

Italian parents

Italian parents were recruited at 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 between September 2020 and March 2022

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Parents awaiting their child\'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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile

Bologna, 40125, Italy

Location

Related Publications (1)

• Cappiello MC, Duran AV, Crystal YO, Bagattoni S, Jimeno FG. Comparison of aesthetic perception and acceptability of silver diamine fluoride staining between Spanish and Italian parents. Sci Rep. 2025 Jan 27;15(1):3442. doi: 10.1038/s41598-025-87347-3.

  PMID: 39870784 DERIVED

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: April 25, 2024
• Study Start: September 1, 2020
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)