Parental Acceptance and Perception of Silver Diamine FlouridApplication Among A Sample of Egyptian Children.

Early Childhood Caries Clinical Trial

Official title:

Parental Acceptance and Perception of Silver Diamine Flouride Application Among A Sample of Egyptian Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04218955
• Other study ID #: Parental acceptance of SDF
• Status: Not yet recruiting
• Start date: January 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: December 2019
• Source: Cairo University
• Contact: Mostafa Waly
• Phone: 01273581262
• Email: Mostafa.AbdalAziz[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Dental caries can be prevented or arrested . Moreover, preventive measures for dental caries are more cost effective than emergency room visits or restorative treatments when the illness has been established . One of the recent preventive methods of dental caries is silver diamine flouride . SDF has been used as an alternative treatment for caries prevention and arrest . Several studies showed that silver diamine flouride cause staining of the treated teeth . However, parents have different attitudes toward using SDF considering its positives and negatives.

Description:

Dental caries is one of the most common diseases in the world, with a prevalence of 69%‐79% . Early childhood caries (ECC) has been recognized by the American Dental Association as an important public health issue and was defined as presence of 1 or more decayed, missing, or filled tooth surfaces (dmfs) in any primary tooth in a preschool-aged child . Caries was known to be managed through two main approaches: Treatment, which includes drill and fill which is a challenge specially in minimally cooperative children and the second approach is prevention which depends on cease the process of caries formation at an early stage which is more effective . One of the recently marketed preventive measures of dental caries is silver diamine fluoride (SDF) .

In 2014, SDF was approved by the US Food and Drug Administration as a treatment for dentinal sensitivity .It was proven to be a cost-effective, minimally invasive, and handy treatment . Silver diamine flouride is easy to apply in a minimally cooperative individual . More important, it has shown a noticeable success rate in caries prevention, especially in early childhood caries cases . It provides families with an alternative solutions for managing dental caries, particularly if caries was detected at an early stage . Moreover, it could save time and effort for both families and dental teams.

The major downside of SDF is the unesthetic permanent black discoloration of the arrested lesion , which could affect parental acceptance for the treatment and may result in shifting to another esthetically acceptable treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: March 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

Inclusion Criteria:

• parents whose children with early childhood caries. Accepting participations.

Exclusion Criteria:

• Refusal of participation.

Related Conditions & MeSH terms

• Early Childhood Caries

Intervention

Combination Product:
• Silver Diamine Flouride
Material used to arrest caries in children

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parental Satisfication about treat their children with silver Diamine flouride	Using Likert scale ranging from Strong Accept ,Accept ,Neutral, Refuse, Strong Refuse.	Baseline