NCT06300034

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

February 23, 2024

Last Update Submit

March 1, 2024

Conditions

Keywords

Silver Diamine FluorideParental perceptions and acceptance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Parental willingness to accept SDF treatment on anterior and posterior teeth depending on child's behavior

    Baseline

  • Parental overall acceptability of SDF staining according to demographic background

    Baseline

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bologna, Italy

Location

Study Officials

  • Simone Bagattoni

    Bologna University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 23, 2024

First Posted

March 8, 2024

Study Start

September 1, 2020

Primary Completion

February 1, 2022

Study Completion

March 1, 2022

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations