Clinical and Laboratory Assessments of Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Caries Among Children and Parental ￼Satisfaction

Study Overview
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Brief Summary
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Globally, it is estimated that 2.4 billion people suffer from caries of permanent teeth and 486 million children suffer from caries of primary teeth . The highest estimate of dental caries prevalence in Saudi Arabia was 95% with maximum DMFT of 7.34 among 3-7 years old children . Also, it was found that 78% of 6-9 years old children in Dammam had caries with an average of 3.66±3.13 DMFT. The objectives of this study are: To assess the effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries. To assess the antibacterial effect of the Silver Diamine Fluoride (SDF). To assess parents' and children's satisfaction and acceptance. The aims of our study are to assess the effectiveness of SDF in arresting caries in primary dentition among children visiting Imam Abdulrahman bin Faisal University in Dammam, Saudi Arabia and to assess parental acceptance and satisfaction. The expected outcome the results of this study will help in understanding the effectiveness SDF in arresting dental caries in this target population especially that it was recently approved for clinical use in Saudi Arabia.

Official Title
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Clinical and Laboratory Assessments of Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Caries Among Children and Parental ￼Satisfaction

Conditions
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Caries Arrested

Intervention / Treatment
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* Other: Silver Diamine Fluoride (SDF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between four and six years of age. Healthy. Have at least two active dentin carious lesions on the primary teeth meeting the International Caries Detection and Assessment System (ICDAS) score 5 or 6. Should not have periapical infection, root resorption or widening in the periodontal ligament space. Exclusion Criteria: Participants who have systemic or neurological diseases. Tooth abscess, pain on percussion, symptoms of pulpal involvement or mobility, Allergic to silver or any dental material to be used. Unable to attend follow-up visits.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: one application of SDF<br> | Other: Silver Diamine Fluoride (SDF)<br>* Silver diamine fluoride (SDF) is one of the topical methods for caries arresting. The advantages of using SDF include ease of use, low cost, pain and infection control, minimal requirement of time/training and non-invasive nature of the procedure. SDF can improve oral health, increase access to care and reduce the need for emergency treatment<br>|
| Experimental: two application of SDF one month apart<br> | Other: Silver Diamine Fluoride (SDF)<br>* Silver diamine fluoride (SDF) is one of the topical methods for caries arresting. The advantages of using SDF include ease of use, low cost, pain and infection control, minimal requirement of time/training and non-invasive nature of the procedure. SDF can improve oral health, increase access to care and reduce the need for emergency treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries. | Caries arresting rate: total number of arrested teeth/ total number of treated teeth. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical changes of dentinal lesion: in the hardness and softness. | Changes in ICDAS score: post treatment change in carious lesion status. | 2 years | 
| The antibacterial effect of the Silver Diamine Fluoride (SDF). | by DNA extractions and performed the 16S rRNA sequencing | 2 years | 
| Parents satisfaction | To assess parents' and children's satisfaction and acceptance by questionnaire (Arabic and English). Link: https://forms.office.com/Pages/ResponsePage.aspx?id=_LuGLASN_0GoOpQvB14PYCVJ8_tHLjNCkOqqrov3N-1UMFlYRzFQUVRKMDhNUEtJR1ZXNkk4SzhGWS4u | 2 years |