Assessing Parental Acceptance to Silver Diamine Fluoride Staining Before and After Masking the Colour With Glass Ionomer

Dina Bassam Mohamed Ahmed

Status: Completed

Conditions: Caries Arrested

Treatments: Procedure: Silver diamine fluoride and glass ionomer; Procedure: Silver diamine fluoride

Study type: Interventional

Funder types: Other

Identifiers

NCT04509232

PED1931M

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: Accepts Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups

group A

Experimental group

Description:

- 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.

Treatment:

Procedure: Silver diamine fluoride

group B

Experimental group

Description:

-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.

Treatment:

Procedure: Silver diamine fluoride and glass ionomer