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To determine the optimal application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children.
Methods: The randomized double blinded clinical trial will recruit 665 healthy kindergarten children aged 3-5 years old with caries and with parental consent. The sample size is sufficient for the appropriate statistical analyses. The children will receive 0.004 mL 38% SDF (typical amount applied per manufacturer's instructions) to treat each caries lesion. The carious teeth were block-randomized into 9 groups with SDF application times of 3, 5, 10, 15, 30, 45, 60, 120, and 180 seconds. The children will be followed up for 6-months in their kindergartens. Clinical examinations after 6-months will be conducted to assess whether the caries is arrested and surface color using a Pantone-based chart. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and 6-months follow-up. The examiner, the children and the children's parents will be blind to the treatment allocation. The analysis will determine the significance of differences between the means of arrested caries at the various follow-ups; and Cochran-Armitage test will be used to evaluate the exposure (SDF-application time) to response relationship.
Significance: This study will help determine the optimal application time in SDF treatment. The study provides an evidence-based protocol for the use of silver diamine fluoride to arrest tooth decay in primary teeth of young children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-second SDF application | Experimental | 3-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children. |
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| 5-second SDF application | Experimental | 5-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children. |
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| 10-second SDF application | Experimental | 10-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children. |
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| 15-second SDF application | Experimental | 15-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children. |
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| 30-second SDF application | Experimental | 30-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-second SDF application | Other | Dosage: 3-second 38% SDF solution application |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Status of Caries Arrest (Surface Hardness) | Surface hardness is independently evaluated by a calibrated examiner using a dental probe with a standard tactile technique. Lesions are classified as "Hard" (indicating successful caries arrest) or "Soft" (indicating an active, non-arrested lesion). | From enrollment to the end of treatment at 6 months |
| dmft index | The tooth discoloration, tooth status (decayed, missing or filled teeth teeth (dmft) index) and tooth mobility | at 6-months follow-up |
| The visible plaque index (VPI). | Two areas (buccal and lingual) of each of the six index teeth (55/51/63/71/75/83) will be examined and recorded (presence/absence) without visible plaque. | at 6-months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Presentation of Lesion Coloration | This assessment evaluates the visual appearance of each dental caries lesion using a standardized Pantone-based coloration chart which including yellow, light brown, dark brown and black. | From enrollment to the end of treatment at 6 months |
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Inclusion Criteria:
(a) 3-5 year old children attending the first to the third year of kindergarten; (b) free from any systemic conditions and generally healthy; (c) parents sign informed consent (d) having at least 1 tooth with cavitated dentine carious lesion.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local kindergartens | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40583169 | Derived | Yan IG, Zheng FM, Sun IG, Lo ECM, Duangthip D, Chu CH. A Randomized Controlled Trial of Silver Diamine Fluoride Application Time. J Dent Res. 2025 Dec;104(13):1453-1461. doi: 10.1177/00220345251345801. Epub 2025 Jun 29. | |
| 35292085 | Derived | Yan IG, Zheng FM, Gao SS, Duangthip D, Lo ECM, Chu CH. Effect of application time of 38% silver diamine fluoride solution on arresting early childhood caries in preschool children: a randomised double-blinded controlled trial protocol. Trials. 2022 Mar 15;23(1):215. doi: 10.1186/s13063-022-06130-1. |
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| 45-second SDF application | Experimental | 45-second application time of silver diamine fluoride (38% SDF) in arresting tooth decay (dental caries) in the primary teeth of preschool children. |
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| 60-second SDF application | Experimental | 60-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children. |
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| 120-second SDF application | Experimental | 120-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children. |
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| 180-second application time | Experimental | 180-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children. |
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| 5-second SDF application |
| Other |
Dosage: 5-second 38% SDF solution application |
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| 10-second SDF application | Other | Dosage: 10-second 38% SDF solution application |
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| 15-second SDF application | Other | Dosage: 15-second 38% SDF solution application |
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| 30-second SDF application | Other | Dosage: 30-second 38% SDF solution application |
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| 45-second SDF application | Other | Dosage: 45-second 38% SDF solution application |
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| 60-second SDF application | Other | Dosage: 60-second 38% SDF solution application |
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| 120-second SDF application | Other | Dosage: 120-second 38% SDF solution application |
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| 180-second SDF application | Other | Dosage: 180-second 38% SDF solution application |
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