Comparative StudySDFNCT06384326
Parental Perceptions and Acceptance of Silver Diamine Fluoride in Spain and Italy
An observational study of Comparative Study and Aesthetic Perception, run by University of Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Comparative Study, Aesthetic Perception, Acceptability
- How many people
- 501 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2020to 1 Aug 2023
- 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- 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
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, 40125
About this study
Official title: Comparison of Aesthetic Perception and Acceptability of Silver Diamine Fluoride Staining Between Spanish and Italian Parents.
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
Read the detailed description
The aim of the present study was to compare aesthetic perceptions and acceptance of SDF pigmentation between Spanish and Italian parents, and assess weather acceptability is influenced by location, child's cooperation, or demographic background. A cross-sectional comparative study was conducted among 267 Spanish parents and 234 Italian parents whose children were attending three university dental clinics. A validated Italian version of the questionnaire "Parental perceptions of Silver Diamine Fluoride Dental Color Changes" was implemented. The questionnaire included sets of colored photographs showing both anterior and posterior teeth before and after SD treatment. Respondents were requested to provide their assessments based on the presented visual stimuli.
- Conditions
- Comparative Study, Aesthetic Perception, Acceptability, SDF
- Keywords
- Silver Diamine Fluoride, Parental perceptions and acceptance, Comparative study, Spain and Italy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (2)
Comparison of SDF's specific acceptability in different scenarios of child's behavior between Spain and Italy
Measurement tool: questionnaire. Acceptance of SD 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 SD 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 SD staining in Spain and Italy.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Sep 2020
- Primary completion1 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Comparative StudyStudies 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
- 501 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384326
- Sponsor's protocol ID
- bagattoni3
- Acronym
- SDF
- Status last verified
- Apr 2024
- First submitted
- 21 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39870784
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Aesthetic Perception and Acceptability of Silver Diamine Fluoride Staining Between Spanish and Italian Parents.
- ClinicalTrials.gov ID
- NCT06384326
- Acronym / sponsor ID
- SDF / bagattoni3
- Conditions
- Comparative Study, Aesthetic Perception, Acceptability, SDF
- Keywords
- Silver Diamine Fluoride, Parental perceptions and acceptance, Comparative study, Spain and Italy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 25 Apr 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.
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
Detailed description
The aim of the present study was to compare aesthetic perceptions and acceptance of SDF pigmentation between Spanish and Italian parents, and assess weather acceptability is influenced by location, child's cooperation, or demographic background. A cross-sectional comparative study was conducted among 267 Spanish parents and 234 Italian parents whose children were attending three university dental clinics. A validated Italian version of the questionnaire "Parental perceptions of Silver Diamine Fluoride Dental Color Changes" was implemented. The questionnaire included sets of colored photographs showing both anterior and posterior teeth before and after SD 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
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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
Comparison of SDF's overall acceptance between Spanish and Italian parents
Time frame: Baseline
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.
2 secondary outcomes
Comparison of SDF's specific acceptability in different scenarios of child's behavior between Spain and Italy
Time frame: Baseline
Parental overall acceptability of SD 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 25 Apr 2024.
- Derived from this study: PubMed 39870784Cappiello 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Comparative Study and Aesthetic Perception, 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 25 Apr 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?
Comparison of SDF's overall acceptance between Spanish and Italian parents (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06384326, which also lists 1 linked publication.
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 25 Apr 2024.