- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06300034
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
Conditions
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
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Bologna, Italy
- Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile
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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
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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.
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Baseline
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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
|
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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.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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