"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"
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 .
Arms & Interventions
group B
-38% Silver diamine fluoride will be applied by the same protocol as in group A
Then Glass Ionomer restoration is applied as follows
- Self cure glass ionomer restoration is applied not light cured as light causes oxidation of silver and the filling appears darker.
- Glass ionomer won't be applied immediately after SDF placement it will be applied at time ranging from 2 hours to two days.
- Conditioning of the base of the cavity is done by 3M ESPE conditioner for 10 seconds then rinsing the cavity for 10 to 20 secs.
- Applying High strength hand mix chemical self cure glass ionomer.
Intervention: Silver diamine fluoride and glass ionomer (Procedure)
group A
- 38% Silver diamine fluoride will be applied to carious lesions by microbrush on the affected surface application time should be 1 min, Application time will be shorter in very young patients.
Intervention: Silver diamine fluoride (Procedure)
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
Dina Bassam Mohamed Ahmed
Dina Bassam Mohamed Ahmed
Ain Shams University