Effect of Application Time of 38% Silver Diamine Fluoride Solution on Arresting Dental Caries in Preschool Childre

Study Overview
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Brief Summary
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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.

Detailed Description
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Methods: The randomized double blinded clinical trial will recruit 414 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 children will be classified into high and low caries rates and equably allocated into nine groups of SDF application time: 3, 5, 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. 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.

Official Title
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Effect of Application Time of 38% Silver Diamine Fluoride Solution on Arresting Dental Caries in Preschool Children: a Randomized Double Blinded Controlled Trial

Conditions
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Early Childhood Caries

Intervention / Treatment
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* Other: 3-second SDF application
* Other: 5-second SDF application
* Other: 10-second SDF application
* Other: 15-second SDF application
* Other: 30-second SDF application
* Other: 45-second SDF application
* Other: 60-second SDF application
* Other: 120-second SDF application
* Other: 180-second SDF application


Participation Criteria
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Eligibility Criteria
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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: uncooperative and difficult to manage, have major systemic diseases such as porphyria, or are on long-term medication such as anti-epileptic drugs.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-second SDF application<br>3-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children. | Other: 3-second SDF application<br>* Dosage: 3-second 38% SDF solution application<br>|
| Experimental: 5-second SDF application<br>5-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children. | Other: 5-second SDF application<br>* Dosage: 5-second 38% SDF solution application<br>|
| Experimental: 10-second SDF application<br>10-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children. | Other: 10-second SDF application<br>* Dosage: 10-second 38% SDF solution application<br>|
| Experimental: 15-second SDF application<br>15-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children. | Other: 15-second SDF application<br>* Dosage: 15-second 38% SDF solution application<br>|
| Experimental: 30-second SDF application<br>30-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children. | Other: 30-second SDF application<br>* Dosage: 30-second 38% SDF solution application<br>|
| Experimental: 45-second SDF application<br>45-second application time of silver diamine fluoride (38% SDF) in arresting tooth decay (dental caries) in the primary teeth of preschool children. | Other: 45-second SDF application<br>* Dosage: 45-second 38% SDF solution application<br>|
| Experimental: 60-second SDF application<br>60-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children. | Other: 60-second SDF application<br>* Dosage: 60-second 38% SDF solution application<br>|
| Experimental: 120-second SDF application<br>120-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children. | Other: 120-second SDF application<br>* Dosage: 120-second 38% SDF solution application<br>|
| Experimental: 180-second application time<br>180-second application time of silver diamine fluoride (38% SDF) in arresting dental caries in the primary teeth of preschool children. | Other: 180-second SDF application<br>* Dosage: 180-second 38% SDF solution application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| dmft index | The tooth discoloration, tooth status (decayed, missing or filled teeth teeth (dmft) index) and tooth mobility | at 6-months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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silver diamine fluoride, application time, preschool children, early childhood caries