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A Clinical Trial of Silver Diamine Fluoride to Arrest Early Childhood Caries in Young Children

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ClinicalTrials.gov Identifier: NCT04054635
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Children's Hospital Research Institute of Manitoba
Information provided by (Responsible Party):
Robert Schroth, DMD, MSc, PhD, University of Manitoba

Brief Summary:
Silver diamine fluoride (SDF) is an antibiotic liquid that has the potential to arrest Early Childhood Caries in young children and delay treatment until children can be seen in outpatient settings. While SDF received approval for clinical use in Canada in 2017 (i.e. Advantage Arrest TM/38% SDF), there has been little guidance on the frequency and duration of applications. This study evaluates the use of SDF at different frequencies to manage dental caries in young children. Potential oral microbiome changes in children receiving SDF treatments are also studied. The investigators hypothesize that two applications of SDF at different frequencies will yield similar arrest rates, and that SDF negatively influences the population of cariogenic bacteria in the oral microbiome. The investigators propose a randomized clinical trial to study the use of SDF to arrest cavitated lesions in primary teeth at different application regimens. Regimen 1 will be two applications of SDF four months apart. Regimen 2 will be two applications of SDF six months apart. Regimen 3 will be two applications of SDF one month apart. Arrest of caries lesions will be determined by assessing clinical hardness, colour change and size of lesions at baseline, at second visit, and at the final study visit. Children < 72 months of age with active caries will be recruited from community-based dental clinics or who are currently on a wait list for dental surgery under general anesthesia in Winnipeg, Manitoba. SDF will be applied on the day of recruitment to cavitated lesions involving dentin followed by 5%NaFV. Depending on which frequency regimen children are randomized to, participants will return for a second visit. At the second visit, caries lesions treated with SDF at baseline will be assessed to see if caries is arrested. A second application of SDF will be applied to these initially treated caries lesions followed by 5%NaFV. Participants will return for a third and final study visit according to the schedule of their randomized grouping. Caries lesions previously treated by SDF will be assessed once again. To investigate SDF's influence on the human oral microbiome, children from each regimen will have plaque samples collected. Samples will be obtained prior to SDF application at baseline, at the first follow-up visit, and at the final visit. Following nucleic acid isolation from plaque samples and amplicon sequencing, data analysis will be performed in lab using established methods.

Condition or disease Intervention/treatment Phase
Early Childhood Caries Device: silver diamine fluoride Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomly assigned to one of three application regimens of silver diamine fluoride (SDF) to cavitated caries lesions in primary teeth during the duration of the study. Regimen 1 will be two applications of SDF four months apart. Regimen 2 will be two applications of SDF six months apart. Regimen 3 will be two applications of SDF one month apart.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Silver Diamine Fluoride to Arrest Early Childhood Caries in Young Children
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
Experimental: Regimen 1
Two applications of silver diamine fluoride (SDF) four months apart, which is the protocol frequency adopted by the Winnipeg Regional Health Authority's (WRHA) Clinical Guideline on SDF.
Device: silver diamine fluoride
Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
Other Name: Advantage Arrest Silver Diamine Fluoride 38%

Experimental: Regimen 2
Two applications of silver diamine fluoride (SDF) six months apart (American Dental Association recommendation)
Device: silver diamine fluoride
Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
Other Name: Advantage Arrest Silver Diamine Fluoride 38%

Experimental: Regimen 3
Two applications of silver diamine fluoride (SDF) one month apart, which is proposed in the American Academy of Pediatric Dentistry's clinical practice guidelines.
Device: silver diamine fluoride
Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
Other Name: Advantage Arrest Silver Diamine Fluoride 38%




Primary Outcome Measures :
  1. Arrest Rate [ Time Frame: 14 months ]
    Total number of teeth arrested/total number of teeth treated

  2. Arrest Rate [ Time Frame: 26 months ]
    Total number of teeth arrested/total number of teeth treated

  3. Arrest Rate [ Time Frame: 10 months ]
    Total number of teeth arrested/total number of teeth treated


Secondary Outcome Measures :
  1. Oral Microbiome [ Time Frame: 14 months ]
    Changes in the composition of the oral microbiome measured through genetic analysis

  2. Oral Microbiome [ Time Frame: 26 months ]
    Changes in the composition of the oral microbiome measured through genetic analysis

  3. Oral Microbiome [ Time Frame: 10 months ]
    Changes in the composition of the oral microbiome measured through genetic analysis



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Ages Eligible for Study:   up to 72 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Child is < 72 months of age with Early Childhood Caries (ECC) with active lesions.
  2. Child has ≥ 1 primary tooth with caries that is eligible to receive SDF. Eligible primary teeth must: a) have soft cavitated caries lesions extending into dentin; b) the cavitated lesions must allow for direct application of silver diamine fluoride (SDF). Teeth that meet any of the PUFA index criteria (i.e. spontaneous pain due to caries, pulp exposure, mobility, signs of pulpal infection such as abscess, fistula, or swelling) will be excluded. However, a child would still be eligible even if they have at least one tooth that meets PUFA criteria, but other eligible teeth with caries do not.

Exclusion Criteria:

  1. Child is allergic or has a sensitivity to silver or other heavy metal ions.
  2. Child has hereditary generalized developmental defects of enamel (e.g. Amelogenesis Imperfecta, Dentinogenesis Imperfecta)
  3. Child has severe medical problems that limit participation.
  4. Child requires immediate rehabilitation under general anesthesia (GA) because of severe infection or pain.
  5. Antibiotic use within the last 2 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054635


Contacts
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Contact: Robert J Schroth 204-975-7764 robert.schroth@umanitoba.ca
Contact: Betty-Anne Mittermuller 204-480-1351 bmittermuller@chrim.ca

Locations
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Canada, Manitoba
Children's Hospital Research Institute of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 3P4
Contact: Robert J Schroth    204-975-7764    robert.schroth@umanitoba.ca   
Contact: Betty-Anne Mittermuller    204-480-1351    bmittermuller@chrim.ca   
Principal Investigator: Robert J Schroth         
Sponsors and Collaborators
University of Manitoba
Children's Hospital Research Institute of Manitoba
Investigators
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Principal Investigator: Robert J Schroth University of Manitoba
Publications:
Schroth RJ, Wilson A, Prowse S, et al. Looking back to move forward: understanding service provider, parent, and caregiver views on early childhood oral health promotion in Manitoba, Canada. Can J Dent Hyg. 2014 Jan;48(3):99-108.
Canadian Institute for Health Information. Treatment of Preventable Dental Cavities in Preschoolers: A Focus on Day Surgery Under General Anesthesia. Ottawa, ON: CIHI; 2013. p. 1-34.
Sihra RB, Martin H, Patterson B, Mitermuller B, Lee V, Klus B, Fontana M, Robertson LD, Schroth RJ. The effectiveness of silver diamine fluoride when used to arrest caries in children and associated oral health-related quality of life. J Can Dent Assoc 2019;Submitted.

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Responsible Party: Robert Schroth, DMD, MSc, PhD, Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT04054635    
Other Study ID Numbers: B2019:068
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Robert Schroth, DMD, MSc, PhD, University of Manitoba:
silver diamine fluoride
randomized clinical trial
early childhood caries
severe early childhood caries
oral microbiome
treatment
arrest
application
frequency
regimen
cariogenic bacteria
early childhood oral health impact scale
oral health-related quality of of life
caries
oral bacteriome
oral mycobiome
cavitated lesions
Additional relevant MeSH terms:
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Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs