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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Caries Arrested

Intervention / Treatment
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* Procedure: Silver diamine fluoride
* Procedure: Silver diamine fluoride and glass ionomer


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Involves two groups of participants. One group receives
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>- 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. | Procedure: Silver diamine fluoride<br>* Group A Excavation of soft carious dentin will be done to minimize the staining. The selected teeth should be cleaned, dried and isolated. Vaselline should be applied to surrounding soft tissues to avoid their staining.- 38% Silver diamine fluoride will be applied to carious lesions by microbrush Apply gentle flow of air until medicament is dry, Try to keep isolated for three minutes,remove excess SDF with cotton pellet to decrease systemic absorption. After silver diamine fluoride application Assessement of parental acceptance to staining will be done though a 5 point likert scale For anterior and posterior teeth separately .<br>* Other names: SDF;|
| Experimental: group B<br>-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. | Procedure: Silver diamine fluoride and glass ionomer<br>* 38% Silver diamine fluoride will be applied by the same protocol as in group A Then Glass Ionomer restoration is applied Parental acceptance to staining will be assessed thought 5 point likert scale after application of SDF and once more after application of Glass Ionomer restoration.<br>* Other names: GIC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessement of Parental perception and Acceptance | 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 Strongly disagree Disagree Neutral Agree Strongly agree | december 2019 to june 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| protocol for placement of silver diamine fluoride with minimal staining | Applying a protocol for placement of silver diamine fluoride with minimal staining as an alternative modality to general anesthesia for treatment of uncooperative patients in the department of pediatric dentistry Ain shams university. | december 2019 to june 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tertiary prevention, Remineralizing agent