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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04218955
Collaborator
(none)
320
14

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Silver Diamine Flouride

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
320 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Parental Acceptance and Perception of Silver Diamine Flouride Application Among A Sample of Egyptian Children
Anticipated Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Jan 1, 2021
Anticipated Study Completion Date :
Mar 1, 2021

Arms and Interventions

Arm Intervention/Treatment
1

Asking parents if they can accept staining from treat their children by silver Diamine Flouride or Not

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

Outcome Measures

Primary Outcome Measures

  1. Parental Satisfication about treat their children with silver Diamine flouride [Baseline]

    Using Likert scale ranging from Strong Accept ,Accept ,Neutral, Refuse, Strong Refuse.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • parents whose children with early childhood caries. Accepting participations.
Exclusion Criteria:
  • Refusal of participation.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mostafa Mohamed Abd El Aziz Waly, Dentist, Cairo University
ClinicalTrials.gov Identifier:
NCT04218955
Other Study ID Numbers:
  • Parental acceptance of SDF
First Posted:
Jan 6, 2020
Last Update Posted:
Jan 6, 2020
Last Verified:
Dec 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 6, 2020