Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish

Study Overview
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Brief Summary
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To assess discoloration of carious primary teeth after application of silver diamine fluoride versus sodium fluoride varnish.

Detailed Description
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The American Academy of Pediatric Dentistry's (AAPD) guidelines (2017) stated that Silver diamine fluoride (SDF) is a brush-on liquid that arrest 87.7% of dental caries lesions. The success rate is similar for restorations placed under GA. One of the most exciting aspects of SDF is the 67±4% decrease in new lesions on untreated surfaces, achieved simply by treating active lesions .This is not the same as incidence of any new lesions (elaborated above for treatment under GA), however the relation warrants further investigation. Benefit to the patient No pain and infection. Enhance child cooperation. Enhance better patient compliance. Decrease cost of dental treatment and may eliminate the need for General Anesthesia. Benefit to the dentist Develop an effective fast easy method to arrest the caries by using SDF. Ease of dental treatment. Better cooperation with the child. The procedure is simple. Inexpensive and non-invasive. It does not require expensive equipment or support infrastructure, such as pipe water or electricity. Benefit to the population Reduce the harmful impact of oral health problems in preschool children from low income families. SDF can be considered a user-friendly material for use in dental clinics as well as remote areas, schools or deprived communities. Children aged 2-5 years can benefit from the use of SDF, an easy anticaries treatment. Furthermore, children in this age group may benefit from delayed dental treatment and overall caries arrest, thus reducing potential pain and infection, expensive future emergency room visits, the need for general anesthesia or traumatic dental experiences on uncooperative children.

Official Title
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Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish: A Randomized Clinical Trial

Conditions
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Dental Caries in Children

Intervention / Treatment
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* Drug: Silver Diamine Fluoride
* Drug: Sodium Fluoride Varnish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with carious primary teeth before eruption of permanent teeth High caries risk patients with anterior or posterior carious lesions Uncooperative children without access to or with difficulty accessing dental care. Exclusion Criteria: Children with spontaneous or elicited pain from caries Tooth mobility Signs of pulpal infection Severe medical conditions that would not allow management in the clinic

Ages Eligible for Study
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Minimum Age: 1 Year
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
Interventional Model Description: patient will receive either silver diamine fluoride or sodium fluoride varnish
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>38% silver diamine fluoride liquid will be applied twice annually and patients will be followed up as 0,1,3,6,9 and 12 SDF is brush on liquid | Drug: Silver Diamine Fluoride<br>* SDF will be applied with a brush<br>* Other names: SDF;|
| Active Comparator: Group 2<br>5% Sodium fluoride varnish will be applied four times annually and patient will be followed up at 0,1,3,6,9 and 12 | Drug: Sodium Fluoride Varnish<br>* NaF will be applied with a brush<br>* Other names: NaF varnish;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discoloration | Discoloration will be assessed by questioning the patient and/or the guardian.binary (yes or no) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator reported discoloration | Investigator will report the discoloration occurred to treated teeth (yellow, brown, black) Visual examination | 12 months | 
| Timing of discoloration | Visual examination at follow up | 12 months | 
| Caries arrest (dentine texture) | Caries arrest will be assessed through tactile examination (Soft or hard) Tactile examination | 12 months | 
| Postoperative Pain: Questioning the patient | Questioning the patient and/or the parentBinary (yes or No) | 12 months | 
| Parental satisfaction: Questioning the parent | Questioning the parent | 12 months |