Clinical trial NCT04509232: Assessing Parental Acceptance to Silver Diamine Fluoride Staining Before and After Masking the Colour With Glass Ionomer
Official title: "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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries Arrested
Keywords: Tertiary prevention
Remineralizing agent
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 82
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Involves two groups of participants. One group receives
Primary purpose: TREATMENT

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.

Before applying any procedures medical history for any silver products allergy (SDF allergy) will be assessed by asking the child's parent.

Materials:

38%SDF

Conditioner 3M ESPE

High strength hand mix chemical cure glass ionomer

Patient withdrawal

Patient who don't comply to the oral hygiene given will be excluded from the study.

Patients who are not willing to continue in the study will have the right to quit at any time without loss of any benefits.

Data Management

Patient information will be gathered and stored in the patient examination chart of the outpatient clinic, Department of Pediatric Dentistry, faculty of Dentistry, Ain Shams University.

All information will be kept as a hard copy and as an electronic one as well. Patient information will be guarded as confidential information that should never be revealed at all times.

Adverse Event Reporting

SDF is not expected to have any adverse effects on healthy subjects, yet failure of treatment, recurrent caries, abcess formation or pulpal affection may be an issue of concern, that will be avoided by the continuous follow up sessions.

Statistical Analysis

Sample size estimation was based on the primary outcome of interest, which is to test whether there's a significant difference in parent satisfaction between the parents of children receiving SDF and those receiving SDF followed by ART restorations. The predicted sample size for comparing parent satisfaction score was found to be 34 children per group (total sample size = 68 children), by assuming an α level of 0.05 and β level of 0.2 (power = 80%). The effect size d was calculated based on the findings of M. Jiang, et al., and the allocation ratio was set at 1. After adjusting for 20% dropout, the final sample size was 41 children per group (total sample size = 82 children). Sample size calculation was performed using G\*Power software version 3.1.4 for MS Windows.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Assessement of Parental perception and Acceptance
timeFrame: december 2019 to june 2021
Secondary outcomes:
measure: protocol for placement of silver diamine fluoride with minimal staining
timeFrame: december 2019 to june 2021
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams university
Study officials:
References:
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