Early Childhood Caries Clinical Trial
Official title:
A Randomized Clinical Trial of Silver Diamine Fluoride to Arrest Early Childhood Caries in Young Children
NCT number | NCT04054635 |
Other study ID # | B2019:068 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2019 |
Est. completion date | July 31, 2023 |
Verified date | August 2023 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | July 31, 2023 |
Est. primary completion date | March 5, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 72 Months |
Eligibility | Inclusion Criteria: 1. Child is < 72 months of age with early childhood caries (ECC) with active lesions (International Caries Detection and Assessment System codes 5 or 6). 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 (pulpal involvement, ulceration, fistula, and abscess) 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Children's Hospital Research Institute of Manitoba | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Children's Hospital Research Institute of Manitoba |
Canada,
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* Note: There are 34 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Arrest Rates | Total number of lesions arrested/total number of lesions treated | 8 months, 12 months, and 2 months | |
Primary | Anterior Teeth Arrest Rates | Total number of anterior lesions arrested/total number of anterior lesions treated. | 8 months, 12 months, and 2 months | |
Primary | Posterior Arrest Rates | Total number of posterior lesions arrested/total number of posterior lesions treated. | 8 months, 12 months, and 2 months |
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