Acceptability Clinical Trial
— SDFOfficial title:
Parental Perceptions and Acceptance of Silver Diamine Fluoride Staining in Italy: A Cross-sectional Study
NCT number | NCT06300034 |
Other study ID # | bagattoni2 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2020 |
Est. completion date | March 1, 2022 |
Verified date | March 2024 |
Source | University of Bologna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 234 |
Est. completion date | March 1, 2022 |
Est. primary completion date | February 1, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile | Bologna |
Lead Sponsor | Collaborator |
---|---|
University of Bologna |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Parental overall acceptance of SDF staining on anterior and posterior teeth | 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 | Parental willingness to accept SDF treatment on anterior and posterior teeth depending on child's behavior | 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 | |
Secondary | Parental overall acceptability of SDF 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 SDF staining in the Italian context. | Baseline |
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