Parental Perceptions and Acceptance of Silver Diamine Fluoride in Italy (SDF)

March 1, 2024 updated by: Simone Bagattoni, University of Bologna

Parental Perceptions and Acceptance of Silver Diamine Fluoride Staining in Italy: A Cross-sectional Study

Parental perceptions on staining due to Silver Diamine Fluoride (SDF) could affect its implementation in pediatric dentistry. This study represents the second part of a wider project focused on SDF aesthetic acceptability among Italian parents.

Study Overview

Status

Completed

Detailed Description

The aim of this survey was to assess the parental acceptance of Silver Diamine Fluoride (SDF) staining in Italy, and to examine wether the level of acceptability depends on location, child's behavior, or demographic background. A cross-sectional study was undertaken, involving 234 Italian parents whose children were attending two university dental clinics. Using a validated Italian version of the questionnaire 'Parental Perceptions of Silver Diamine Fluoride Dental Color Changes', researchers administered a series of closed-ended Likert-type questions to parents. The questionnaire included sets of colored photographs showing both anterior and posterior teeth before and after SDF treatment. Respondents were requested to provide their assessments based on the presented visual stimuli.

Study Type

Observational

Enrollment (Actual)

234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bologna, Italy
        • Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Parents awaiting their child's dental appointments at two distinct locations: 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.

Description

Inclusion Criteria:

  • Italian-speaking parents
  • 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 Italian-speaking parents
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental overall acceptance of SDF staining on anterior and posterior teeth
Time Frame: Baseline
Measurement tool: questionnaire. Specific questions focused on the general acceptability of the visible 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental willingness to accept SDF treatment on anterior and posterior teeth depending on child's behavior
Time Frame: Baseline
Measurement tool: questionnaire. Acceptance of SDF 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
Parental overall acceptability of SDF staining according to demographic background
Time Frame: Baseline
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 SDF staining in the Italian context.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Simone Bagattoni, Bologna University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • bagattoni2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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