NCT04766775

Brief Summary

This study focus on the pharmacokinetic characteristic of silver diamine fluoride (SDF) in healthy children. All of the children received treatment for the decayed teeth in the same way. A medication called silver diamine fluoride is used to treat the decayed teeth. It contains a high concentration of fluoride (range from 14100 ppm to 51013 ppm) and silver. This medication halts the decay process through the combined effects of anti-bacterial from silver and remineralization from fluoride. As this product contains the highest concentration of fluoride level found in the market and the metal element of silver, the investigators aim to study the body's reaction towards SDF. The investigators collect the hair and urine samples at different time points and then analyze them to determine the silver and/or fluoride levels. The outcomes include 1. the silver level in the hair and urine samples 2. the fluoride level in the urine samples. The investigators analyze the silver level in hair and urine samples using Inductively Coupled Plasma Mass Spectrometry (ICP-MS); fluoride level in urine samples using Ion-Selective Electrode.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

February 4, 2021

Last Update Submit

March 1, 2021

Conditions

Dental Caries in Children

Keywords

silver diamine fluoride

Outcome Measures

Primary Outcomes (8)

  • To assess the silver level in the hair samples (µg/g)

    SDF treatment will be provided to the patients, hair samples will be collected at day 7 after the SDF treatment

    7 days

  • To assess the silver level in the hair samples (µg/g)

    SDF treatment will be provided to the patients, hair samples will be collected at day 14 after the SDF treatment

    14 days

  • To assess the silver level in the hair samples (µg/g)

    SDF treatment will be provided to the patients, hair samples will be collected at day 30 after the SDF treatment

    30 days

  • To assess the silver level in the hair samples (µg/g)

    SDF treatment will be provided to the patients, hair samples will be collected at day 60 after the SDF treatment

    60 days

  • To assess the silver level in the hair samples (µg/g)

    SDF treatment will be provided to the patients, hair samples will be collected at day 75 after the SDF treatment

    75 days

  • To assess the silver level in the hair samples (µg/g)

    SDF treatment will be provided to the patients, hair samples will be collected at day 90 after the SDF treatment

    90 days

  • To assess the fluoride level in the urine samples (µg/24h)

    SDF treatment will be provided to the patients, urine samples will be collected before the start of the treatment; in the first and second 24 hour after the treatment

    72 hours

  • To assess the silver level in the urine samples (µg/24h)

    SDF treatment will be provided to the patients, urine samples will be collected before the start of the treatment; in the first and second 24 hour after the treatment

    72 hours

Study Arms (1)

Application of Silver Diamine Fluoride onto the carious teeth surfaces

OTHER

The patients will receive Silver Diamine Fluoride (SDF) treatment to the carious primary teeth. These are teeth with no sign or symptom, radiographically the deepest layer of the caries lesion does not involve the pulp, the inter-radicular area appears normal). Procedure: apply vaseline, isolate the tooth with a cotton roll, remove the food debris, and gross plaque on the tooth cavity with a spoon excavator, dry the tooth, apply the SDF (a clear, colorless solution) onto the tooth cavity. This application lasts for one minute. Take the urine and hair sample to assess the silver and fluoride levels. Take the urine sample before the SDF treatment, in the first and second 24 hours after the SDF treatment. Take the hair samples before the SDF treatment, followed by days 7,14,30,60,75, and 90 after the SDF treatment. Send the hair and urine samples to the laboratory to assess the silver and fluoride levels. If caries remains active, restore the SDF treated after the day 90 review.

Device: Silver Diamine Fluoride

Interventions

Silver Diamine FluorideDEVICE

Silver Diamine Fluoride (Riva Star) which contains silver, fluoride, ammonia and water.

Application of Silver Diamine Fluoride onto the carious teeth surfaces

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \. Healthy children aged between 4 to 10 years old
  • With at least one decayed primary tooth without clinical signs or symptoms suggesting reversible or irreversible pulpitis.
  • Radiographically the deepest layer of caries lesion does not encroach on pulp, and inter-radicular supporting structures appear normal

You may not qualify if:

  • Children aged below 4 years and above 10 years
  • Healthy children aged between 4 to 10 years old
  • Do not have decayed teeth
  • The decayed tooth with clinical signs or symptoms suggesting reversible or irreversible pulpitis
  • Radiographically the deepest layer of caries lesion does encroach on pulp, and inter-radicular supporting structures appear abnormal
  • No consent and permission to join the study
  • Taking medications/over the counter medications/supplements
  • Known allergy to silver or fluoride
  • Presence of ulcer in the mouth which has not heal completely
  • Presence of at least one tooth treated with silver fillings or stainless steel crown.
  • Presence of at least one tooth filled with a material that contains glass particles known as glass ionomer within a year before this research.
  • Children with medical problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malaya

Kuala Lumpur, Kuala, 50603, Malaysia

Location

Related Publications (14)

  • Vasquez E, Zegarra G, Chirinos E, Castillo JL, Taves DR, Watson GE, Dills R, Mancl LL, Milgrom P. Short term serum pharmacokinetics of diammine silver fluoride after oral application. BMC Oral Health. 2012 Dec 31;12:60. doi: 10.1186/1472-6831-12-60.

    PMID: 23272643BACKGROUND

  • Chen KF, Milgrom P, Lin YS. Silver Diamine Fluoride in Children Using Physiologically Based PK Modeling. J Dent Res. 2020 Jul;99(8):907-913. doi: 10.1177/0022034520917368. Epub 2020 May 6.

    PMID: 32374712BACKGROUND

  • Lansdown AB. Silver in health care: antimicrobial effects and safety in use. Curr Probl Dermatol. 2006;33:17-34. doi: 10.1159/000093928.

    PMID: 16766878BACKGROUND

  • Crystal YO, Marghalani AA, Ureles SD, Wright JT, Sulyanto R, Divaris K, Fontana M, Graham L. Use of Silver Diamine Fluoride for Dental Caries Management in Children and Adolescents, Including Those with Special Health Care Needs. Pediatr Dent. 2017 Sep 15;39(5):135-145.

    PMID: 29070149BACKGROUND

  • Lansdown AB. Silver. I: Its antibacterial properties and mechanism of action. J Wound Care. 2002 Apr;11(4):125-30. doi: 10.12968/jowc.2002.11.4.26389.

    PMID: 11998592BACKGROUND

  • Ngara B, Zvada S, Chawana TD, Stray-Pedersen B, Nhachi CFB, Rusakaniko S. A population pharmacokinetic model is beneficial in quantifying hair concentrations of ritonavir-boosted atazanavir: a study of HIV-infected Zimbabwean adolescents. BMC Pharmacol Toxicol. 2020 Aug 3;21(1):58. doi: 10.1186/s40360-020-00437-y.

    PMID: 32746923BACKGROUND

  • Cooper GA, Kronstrand R, Kintz P; Society of Hair Testing. Society of Hair Testing guidelines for drug testing in hair. Forensic Sci Int. 2012 May 10;218(1-3):20-4. doi: 10.1016/j.forsciint.2011.10.024. Epub 2011 Nov 15.

    PMID: 22088946BACKGROUND

  • Kintz P. Hair Analysis in Forensic Toxicology: An Updated Review with a Special Focus on Pitfalls. Curr Pharm Des. 2017;23(36):5480-5486. doi: 10.2174/1381612823666170929155628.

    PMID: 28969544BACKGROUND

  • Lin YS, Rothen ML, Milgrom P. Pharmacokinetics of 38% topical silver diamine fluoride in healthy adult volunteers. J Am Dent Assoc. 2019 Mar;150(3):186-192. doi: 10.1016/j.adaj.2018.10.018.

    PMID: 30803490RESULT

  • Villa A, Anabalon M, Zohouri V, Maguire A, Franco AM, Rugg-Gunn A. Relationships between fluoride intake, urinary fluoride excretion and fluoride retention in children and adults: an analysis of available data. Caries Res. 2010;44(1):60-8. doi: 10.1159/000279325. Epub 2010 Feb 2.

    PMID: 20130402RESULT

  • Wilschefski SC, Baxter MR. Inductively Coupled Plasma Mass Spectrometry: Introduction to Analytical Aspects. Clin Biochem Rev. 2019 Aug;40(3):115-133. doi: 10.33176/AACB-19-00024.

    PMID: 31530963RESULT

  • DiVincenzo GD, Giordano CJ, Schriever LS. Biologic monitoring of workers exposed to silver. Int Arch Occup Environ Health. 1985;56(3):207-15. doi: 10.1007/BF00396598.

    PMID: 4066049RESULT

  • Goulle JP, Mahieu L, Castermant J, Neveu N, Bonneau L, Laine G, Bouige D, Lacroix C. Metal and metalloid multi-elementary ICP-MS validation in whole blood, plasma, urine and hair. Reference values. Forensic Sci Int. 2005 Oct 4;153(1):39-44. doi: 10.1016/j.forsciint.2005.04.020.

    PMID: 15979835RESULT

  • World Health Organization. (2014). Basic methods for assessing renal fluoride excretion in community prevention programmes for oral health. World Health Organization. https://apps.who.int/iris/handle/10665/112662

    RESULT

Study Officials

  • Siau Peng Lim, DDS (USM)

    University of Malaya, Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: ll of the patients enrolled in the study (aged 4 to 10 years old) will receive Silver Diamine Fluoride (SDF) treatment to the decayed primary tooth/teeth by having the application of Silver Diamine Fluoride (SDF) onto the tooth cavity. The weight of the SDF capsule and brush will be measured before and after the SDF application. This step approximates the amount of SDF applied to the tooth surface. Urine and hair samples will be taken to assess the silver and fluoride levels. Urine samples will be taken before the SDF treatment, in the first and second 24 hours after the SDF treatment. For the hair samples, it will be taken before the SDF treatment as well as day 7,14,30,60,75, and 90 after the SDF treatment. After the day 90 review, if caries remains active, the SDF treated teeth will be restored or undergo a six-monthly SDF application.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Postgraduate student year 3, Department of Paediatric Dentistry

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 23, 2021

Study Start

July 3, 2020

Primary Completion

November 26, 2020

Study Completion

November 26, 2021

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)