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Clinical Trials/NCT04509232
NCT04509232CompletedNot Applicable

"Parental Perception and Acceptance of the Utilization of Silver Diamine Fluoride on Their Child's Anterior and Posterior Teeth Before and After Masking the Colour With Glass Ionomer"

Dina Bassam Mohamed Ahmed1 site in 1 country82 target enrollmentStarted: October 12, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
82
Locations
1
Primary Endpoint
Assessement of Parental perception and Acceptance

Study Overview

Brief Summary

Assessing Parents acceptance for the colour of Silver Diamine Fluoride on their Children anterior and posterior teeth before and after masking its colour with Glass Ionomer.

Detailed Description

Sample size estimation Sample size estimation was based on the primary outcome of interest The final sample size was 41 children per group (total sample size = 82 children)

Patients will be recruited randomly from outpatient clinic of the Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Ain Shams University. A signed informed consent to the parents' and also an insent to child,outlined by the Ethical Committee, Faculty of Dentistry, Ain Shams University will be obtained before the conduction of the study.

All examination procedures will be done by the same operator to ensure standardization.

Moreover, all patients will receive oral health education in regard to dietary and oral hygiene habits.

Excluded carious primary molars will be scheduled to receive the appropriate treatment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
3 Years to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Uncooperative patients.
  • Patients whom their parents refuse or cannot afford the cost of GA surgeries.
  • Teeth that are restorable with restoration and doesn't need full coverage.
  • Teeth which are free of symptoms of pulpal pathology.
  • Children with anterior and posterior carious teeth with minimum of two teeth.

Exclusion Criteria

  • Patients whom their parents totally refuse Silver diamine fluoride staining .
  • Children suffering from any medical condition that can't be managed in the clinic.
  • Children with known allergies to silver products.
  • Children with severe forms of hypoplasia .

Outcomes

Primary Outcomes

Assessement of Parental perception and Acceptance

Time Frame: december 2019 to june 2021

Assessement of Parental Perception and Acceptance of the Utilization of Silver Diamine Fluoride on their Child's Anterior and Posterior Teeth before and after masking the colour with Glass Ionomer through 5 point likert scale The format of the five-level Likert scale will be 1. Strongly disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly agree

Secondary Outcomes

  • protocol for placement of silver diamine fluoride with minimal staining(december 2019 to june 2021)

Investigators

Sponsor
Dina Bassam Mohamed Ahmed
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Dina Bassam Mohamed Ahmed

Dina Bassam Mohamed Ahmed

Ain Shams University

Study Sites (1)

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