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Completed

NCT Number: NCT06384326

Parental Perceptions and Acceptance of Silver Diamine Fluoride in Spain and Italy

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

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Key information

Conditions

Comparative Study Acceptability Aesthetic Perception SDF

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile

Bologna, 40125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Comparison of SDF's specific acceptability in different scenarios of child's behavior between Spain and Italy

    Time frame: Baseline

    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.

  2. Parental overall acceptability of SD 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 SD staining in Spain and Italy.

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

Comparison of Aesthetic Perception and Acceptability of Silver Diamine Fluoride Staining Between Spanish and Italian Parents.

Acronym: SDF

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2024
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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