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

NCT04509232 | Completed

• 1 other identifier: PED1931M
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries Arrested

Keywords

Tertiary prevention; Remineralizing agent

Outcome Measures

Primary Outcomes (1)

• 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 1. Strongly disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly agree

  december 2019 to june 2021

Secondary Outcomes (1)

• protocol for placement of silver diamine fluoride with minimal staining

  december 2019 to june 2021

Study Arms (2)

group A

EXPERIMENTAL

\- 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 B

EXPERIMENTAL

-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

Interventions

Silver diamine fluoride PROCEDURE

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 .

Also known as: SDF

group A

Silver diamine fluoride and glass ionomer PROCEDURE

* 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.

Also known as: SDF, GIC

group B

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Dina Bassam Mohamed Ahmed: lead

Study Sites (1)

Ainshams university

Cairo, Egypt

Location

Related Publications (12)

• 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.

  PMID: 28770188 BACKGROUND

• 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.

  PMID: 28749529 BACKGROUND

• 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.

  PMID: 28798464 BACKGROUND

• Caries-risk Assessment and Management for Infants, Children, and Adolescents. Pediatr Dent. 2018 Oct 15;40(6):205-212. No abstract available.

  PMID: 32074889 BACKGROUND

• 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.

  PMID: 28542863 BACKGROUND

• 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.

  PMID: 28387277 BACKGROUND

• Policy on the Use of Silver Diamine Fluoride for Pediatric Dental Patients. Pediatr Dent. 2018 Oct 15;40(6):51-54. No abstract available.

  PMID: 32074849 BACKGROUND

• 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.

  PMID: 30447792 BACKGROUND

• 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.

  PMID: 29355424 BACKGROUND

• 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.

  PMID: 28457477 BACKGROUND

• 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.

  PMID: 24383434 BACKGROUND

• 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.

  PMID: 30983942 BACKGROUND

MeSH Terms

Interventions

silver diamine fluoride; glass ionomer

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dina Bassam Mohamed Ahmed

Model Details: Involves two groups of participants. One group receives

Study Record Dates

• First Submitted: August 8, 2020
• First Posted: August 11, 2020
• Study Start: October 12, 2019
• Primary Completion: July 22, 2021
• Study Completion: September 22, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)