PerceptionsSDFNCT06300034
Parental Perceptions and Acceptance of Silver Diamine Fluoride in Italy
An observational study of Perceptions and Acceptability, run by University of Bologna at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perceptions, Acceptability, SDF
- How many people
- 234 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2020to 1 Mar 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile
Bologna
About this study
Official title: 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.
Read the 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.
- Conditions
- Perceptions, Acceptability, SDF
- Keywords
- Silver Diamine Fluoride, Parental perceptions and acceptance
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (2)
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Sep 2020
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerceptionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 234 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Bagattoni, University of Bologna
- Investigators
- Simone Bagattoni, Principal investigator, Bologna University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300034
- Sponsor's protocol ID
- bagattoni2
- Acronym
- SDF
- Status last verified
- Mar 2024
- First submitted
- 23 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Perceptions and Acceptance of Silver Diamine Fluoride Staining in Italy: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06300034
- Acronym / sponsor ID
- SDF / bagattoni2
- Conditions
- Perceptions, Acceptability, SDF
- Keywords
- Silver Diamine Fluoride, Parental perceptions and acceptance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Parental willingness to accept SDF treatment on anterior and posterior teeth depending on child's behavior
Time frame: Baseline
Parental overall acceptability of SDF staining according to demographic background
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Bagattoni principal investigator
Bologna University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perceptions and Acceptability, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental overall acceptance of SDF staining on anterior and posterior teeth (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.