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

Primary Purpose

Caries Arrested

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Silver diamine fluoride
Silver diamine fluoride and glass ionomer
Sponsored by
Dina Bassam Mohamed Ahmed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries Arrested focused on measuring Tertiary prevention, Remineralizing agent

Eligibility Criteria

3 Years - 7 Years (Child)All SexesAccepts 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 .

Sites / Locations

  • Ainshams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group A

group B

Arm 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.

-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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
August 8, 2020
Last Updated
September 24, 2021
Sponsor
Dina Bassam Mohamed Ahmed
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1. Study Identification

Unique Protocol Identification Number
NCT04509232
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 12, 2019 (Actual)
Primary Completion Date
July 22, 2021 (Actual)
Study Completion Date
September 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dina Bassam Mohamed Ahmed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries Arrested
Keywords
Tertiary prevention, Remineralizing agent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Involves two groups of participants. One group receives
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm 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.
Arm Title
group B
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Silver diamine fluoride
Other Intervention Name(s)
SDF
Intervention Description
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 .
Intervention Type
Procedure
Intervention Name(s)
Silver diamine fluoride and glass ionomer
Other Intervention Name(s)
SDF, GIC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessement of Parental perception and Acceptance
Description
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
Time Frame
december 2019 to june 2021
Secondary Outcome Measure Information:
Title
protocol for placement of silver diamine fluoride with minimal staining
Description
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.
Time Frame
december 2019 to june 2021

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 .
Facility Information:
Facility Name
Ainshams university
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28770188
Citation
Anil S, Anand PS. Early Childhood Caries: Prevalence, Risk Factors, and Prevention. Front Pediatr. 2017 Jul 18;5:157. doi: 10.3389/fped.2017.00157. eCollection 2017.
Results Reference
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PubMed Identifier
28749529
Citation
Clemens J, Gold J, Chaffin J. Effect and acceptance of silver diamine fluoride treatment on dental caries in primary teeth. J Public Health Dent. 2018 Dec;78(1):63-68. doi: 10.1111/jphd.12241. Epub 2017 Jul 27.
Results Reference
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PubMed Identifier
28798464
Citation
Innes NP, Manton DJ. Minimum intervention children's dentistry - the starting point for a lifetime of oral health. Br Dent J. 2017 Aug 11;223(3):205-213. doi: 10.1038/sj.bdj.2017.671.
Results Reference
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PubMed Identifier
32074889
Citation
Caries-risk Assessment and Management for Infants, Children, and Adolescents. Pediatr Dent. 2018 Oct 15;40(6):205-212. No abstract available.
Results Reference
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PubMed Identifier
28542863
Citation
Zhao IS, Gao SS, Hiraishi N, Burrow MF, Duangthip D, Mei ML, Lo EC, Chu CH. Mechanisms of silver diamine fluoride on arresting caries: a literature review. Int Dent J. 2018 Apr;68(2):67-76. doi: 10.1111/idj.12320. Epub 2017 May 21.
Results Reference
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PubMed Identifier
28387277
Citation
JUCSF protocol for caries arrest using silver diamine fluoride: rationale, indications, and consent. Br Dent J. 2017 Apr 7;222(7):516. doi: 10.1038/sj.bdj.2017.311.
Results Reference
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PubMed Identifier
32074849
Citation
Policy on the Use of Silver Diamine Fluoride for Pediatric Dental Patients. Pediatr Dent. 2018 Oct 15;40(6):51-54. No abstract available.
Results Reference
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PubMed Identifier
30447792
Citation
Crystal YO, Niederman R. Evidence-Based Dentistry Update on Silver Diamine Fluoride. Dent Clin North Am. 2019 Jan;63(1):45-68. doi: 10.1016/j.cden.2018.08.011.
Results Reference
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PubMed Identifier
29355424
Citation
Burgess JO, Vaghela PM. Silver Diamine Fluoride: A Successful Anticarious Solution with Limits. Adv Dent Res. 2018 Feb;29(1):131-134. doi: 10.1177/0022034517740123.
Results Reference
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PubMed Identifier
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Citation
Crystal YO, Janal MN, Hamilton DS, Niederman R. Parental perceptions and acceptance of silver diamine fluoride staining. J Am Dent Assoc. 2017 Jul;148(7):510-518.e4. doi: 10.1016/j.adaj.2017.03.013. Epub 2017 Apr 27.
Results Reference
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PubMed Identifier
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Citation
Chu CH, Lee AH, Zheng L, Mei ML, Chan GC. Arresting rampant dental caries with silver diamine fluoride in a young teenager suffering from chronic oral graft versus host disease post-bone marrow transplantation: a case report. BMC Res Notes. 2014 Jan 3;7:3. doi: 10.1186/1756-0500-7-3.
Results Reference
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PubMed Identifier
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Citation
Alshammari AF, Almuqrin AA, Aldakhil AM, Alshammari BH, Lopez JNJ. Parental perceptions and acceptance of silver diamine fluoride treatment in Kingdom of Saudi Arabia. Int J Health Sci (Qassim). 2019 Mar-Apr;13(2):25-29.
Results Reference
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Assessing Parental Acceptance to Silver Diamine Fluoride Staining Before and After Masking the Colour With Glass Ionomer

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