Assessing Parental Acceptance to Silver Diamine Fluoride Staining Before and After Masking the Colour With Glass Ionomer
Condition: Caries Arrested
MeSH terms: Heart Arrest
Study type: Interventional

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.
    

Intervention name(s): Silver diamine fluoride; Silver diamine fluoride and glass ionomer
Intervention type(s): Procedure; Procedure
Intervention description(s): 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 .; 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.
Other intervention name(s): SDF; SDF; GIC
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Involves two groups of participants. One group receives
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tertiary prevention; Remineralizing agent