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

September 24, 2021 updated by: Dina Bassam Mohamed Ahmed

"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"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • AinShams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Silver diamine fluoride

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 .

Other Names:
  • SDF
Experimental: 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.
Procedure: Silver diamine fluoride and glass ionomer
  • 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 Names:
  • SDF
  • GIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
december 2019 to june 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
protocol for placement of silver diamine fluoride with minimal staining
Time Frame: december 2019 to june 2021
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dina Bassam Mohamed Ahmed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2019

Primary Completion (Actual)

July 22, 2021

Study Completion (Actual)

September 22, 2021

Study Registration Dates

First Submitted

August 8, 2020

First Submitted That Met QC Criteria

August 8, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 24, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED1931M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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