Dental Caries in ChildrenSDFNCT04766775
The Pharmacokinetics of Silver Diamine Fluoride (SDF) in Healthy Children
A study testing Silver Diamine Fluoride in people with Dental Caries in Children, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Silver Diamine Fluoride
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteMalaysia
- Study dates
- 3 Jul 2020to 26 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This research aims to determine the pharmacokinetics characteristics of silver and fluoride following topical application of Silver Diamine Fluoride (SDF) in healthy children. The use of Silver Diamine Fluoride is increasingly widespread since the device is approved by the Food and Drug Administration (FDA) of the United States in 2014, especially among the pediatric population. It is a single-arm, clinical study with the specific objectives: 1. to assess the level of silver and fluoride in the urine sample of patients receiving the SDF treatment; 2. to evaluate the pharmacokinetics of silver, based on the hair sample of patients receiving the SDF treatment. The investigators hypothesize that the pharmacokinetic characteristics of silver diamine fluoride in healthy children are different from that of silver diamine fluoride in healthy adults. The research is taking place at the Paediatrics Dentistry Specialist Clinic, Faculty of Dentistry, University of Malaya. The investigators have used a convenience sampling method to recruit children aged 4-10 years old to join the study. The investigators have calculated the sample size based on the alpha error probability of 0.05 and the power of study at 95%. The investigators have recruited children with at least one decayed primary tooth without clinical signs or symptoms. Radiographically the deepest layer of caries lesion does not involve the pulp. The investigators have excluded children with known medical illness, having glass ionomer or stainless steel crown restorations in the oral cavity. All of the recruited patients received the same intervention, the application of SDF onto the tooth cavity. The investigators have taken the patients' biological samples (urine and hair) to assess the silver and/or fluoride levels. The urine samples are collected before the SDF treatment, in the first and second 24 hours after the SDF treatment. Besides that, hair samples are collected before the SDF treatment, followed by days 7,14,30,60,75, and 90 after the SDF treatment. The silver level in hair and urine samples were analyzed using Inductively Coupled Plasma Mass Spectrometry (ICP-MS); fluoride level in urine samples using Ion-Selective Electrode. After review at days 90, if caries remains active despite the SDF treatment, the investigators will restore the SDF treated teeth or continue the six-monthly application of SDF depending on the patient's ability to cope with the procedure and the caries status.
- Conditions
- Dental Caries in Children
- Being tested
- Silver Diamine Fluoride
- Keywords
- silver diamine fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diamine FluorideDevice
Silver Diamine Fluoride (Riva Star) which contains silver, fluoride, ammonia and water.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Silver Diamine Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start3 Jul 2020
- Primary completion26 Nov 2020
- Study completion26 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Lim Siau Peng, University of Malaya
- Investigators
- Siau Peng Lim, DDS (USM), Principal investigator, University of Malaya, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766775
- Sponsor's protocol ID
- DF CD1914/0065/20157 (P)
- Acronym
- SDF
- Status last verified
- Mar 2021
- First submitted
- 4 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23272643Chen 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.
PubMed 32374712Lansdown AB. Silver in health care: antimicrobial effects and safety in use. Curr Probl Dermatol. 2006;33:17-34. doi: 10.1159/000093928.
PubMed 16766878Crystal 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.
PubMed 29070149Lansdown 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.
PubMed 11998592Ngara 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.
PubMed 32746923Cooper 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.
PubMed 22088946Kintz 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.
PubMed 28969544Lin 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.
PubMed 30803490Villa 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.
PubMed 20130402Wilschefski 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.
PubMed 31530963DiVincenzo 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.
PubMed 4066049Goulle 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.
PubMed 15979835World 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics of Silver Diamine Fluoride (SDF) in Healthy Children
- ClinicalTrials.gov ID
- NCT04766775
- Acronym / sponsor ID
- SDF / DF CD1914/0065/20157 (P)
- Conditions
- Dental Caries in Children
- Keywords
- silver diamine fluoride
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 26 Nov 2021 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This research aims to determine the pharmacokinetics characteristics of silver and fluoride following topical application of Silver Diamine Fluoride (SDF) in healthy children. The use of Silver Diamine Fluoride is increasingly widespread since the device is approved by the Food and Drug Administration (FDA) of the United States in 2014, especially among the pediatric population. It is a single-arm, clinical study with the specific objectives: 1. to assess the level of silver and fluoride in the urine sample of patients receiving the SDF treatment; 2. to evaluate the pharmacokinetics of silver, based on the hair sample of patients receiving the SDF treatment. The investigators hypothesize that the pharmacokinetic characteristics of silver diamine fluoride in healthy children are different from that of silver diamine fluoride in healthy adults. The research is taking place at the Paediatrics Dentistry Specialist Clinic, Faculty of Dentistry, University of Malaya. The investigators have used a convenience sampling method to recruit children aged 4-10 years old to join the study. The investigators have calculated the sample size based on the alpha error probability of 0.05 and the power of study at 95%. The investigators have recruited children with at least one decayed primary tooth without clinical signs or symptoms. Radiographically the deepest layer of caries lesion does not involve the pulp. The investigators have excluded children with known medical illness, having glass ionomer or stainless steel crown restorations in the oral cavity. All of the recruited patients received the same intervention, the application of SDF onto the tooth cavity. The investigators have taken the patients' biological samples (urine and hair) to assess the silver and/or fluoride levels. The urine samples are collected before the SDF treatment, in the first and second 24 hours after the SDF treatment. Besides that, hair samples are collected before the SDF treatment, followed by days 7,14,30,60,75, and 90 after the SDF treatment. The silver level in hair and urine samples were analyzed using Inductively Coupled Plasma Mass Spectrometry (ICP-MS); fluoride level in urine samples using Ion-Selective Electrode. After review at days 90, if caries remains active despite the SDF treatment, the investigators will restore the SDF treated teeth or continue the six-monthly application of SDF depending on the patient's ability to cope with the procedure and the caries status.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Application of Silver Diamine Fluoride onto the carious teeth surfaces | Other | Device: Silver Diamine FluorideThe 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. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1. 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
Key exclusion criteria (12 listed)
- Children aged below 4 years and above 10 years
- Healthy children aged between 4 to 10 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver Diamine FluorideSilver Diamine Fluoride (Riva Star) which contains silver, fluoride, ammonia and water. | Device | Application of Silver Diamine Fluoride onto the carious teeth surfaces |
Primary outcome
To assess the silver level in the hair samples (µg/g)
Time frame: 7 days
SDF treatment will be provided to the patients, hair samples will be collected at day 7 after the SDF treatment
To assess the silver level in the hair samples (µg/g)
Time frame: 14 days
SDF treatment will be provided to the patients, hair samples will be collected at day 14 after the SDF treatment
To assess the silver level in the hair samples (µg/g)
Time frame: 30 days
SDF treatment will be provided to the patients, hair samples will be collected at day 30 after the SDF treatment
To assess the silver level in the hair samples (µg/g)
Time frame: 60 days
SDF treatment will be provided to the patients, hair samples will be collected at day 60 after the SDF treatment
To assess the silver level in the hair samples (µg/g)
Time frame: 75 days
SDF treatment will be provided to the patients, hair samples will be collected at day 75 after the SDF treatment
To assess the silver level in the hair samples (µg/g)
Time frame: 90 days
SDF treatment will be provided to the patients, hair samples will be collected at day 90 after the SDF treatment
To assess the fluoride level in the urine samples (µg/24h)
Time frame: 72 hours
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
To assess the silver level in the urine samples (µg/24h)
Time frame: 72 hours
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Background: PubMed 23272643Vasquez 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.
- Background: PubMed 32374712Chen 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.
- Background: PubMed 16766878Lansdown AB. Silver in health care: antimicrobial effects and safety in use. Curr Probl Dermatol. 2006;33:17-34. doi: 10.1159/000093928.
- Background: PubMed 29070149Crystal 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.
- Background: PubMed 11998592Lansdown 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.
- Background: PubMed 32746923Ngara 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.
- Background: PubMed 22088946Cooper 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.
- Background: PubMed 28969544Kintz 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.
- Results publication: PubMed 30803490Lin 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.
- Results publication: PubMed 20130402Villa 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.
- Results publication: PubMed 31530963Wilschefski 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.
- Results publication: PubMed 4066049DiVincenzo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siau Peng Lim, DDS (USM) principal investigator
University of Malaya, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Diamine Fluoride in people with Dental Caries in Children, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the silver level in the hair samples (µg/g) (time frame: 7 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04766775, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.