Application of SDF Verses NaF Varnish in Treatment of Carious Primary Teeth

Study Overview
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Brief Summary
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The aim of this study is to assess the postoperative pain after application of silver diamine fluoride versus sodium fluoride varnish in treatment of carious primary teeth.

Detailed Description
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Untreated dental decay and poor access to dental care are significant Public health problems for children in the world (Dye et al. 2015 and Horst, 2016). Early childhood caries is a multifactorial, infectious and transmissible dental disease affecting young children . Conventional restorative treatment may fail to reduce the burden of early childhood caries in many parts of the world. Most decayed teeth in preschool children remained unrestored . Consequences of untreated decay in preschool children may include increased risk of future caries in primary and permanent dentition, pain and infections; increased expensive emergency room visits and hospital admissions; increased treatment costs because of extensive decay and the accompanying need for general anesthesia; delayed growth and development; and missed days from school and work .To reduce the burden of caries disease in young children and to avoid possible serious consequences of untreated decay, it is important to identify an effective, low-cost method of treating caries in children at high risk of caries and with limited access to dental care. Silver diamine fluoride (SDF) has been identified as an anticariogenic agent that successfully arrests dental decay and has the potential to address the epidemic of untreated decay in young children Therefore this study will be conducted to assess the postoperative pain after application of silver diamine fluoride versus sodium fluoride varnish in treatment of carious primary teeth. Benefits of the research to the patient: According to American Academy of Pediatric Dentistry (AAPD), 2017 SDF application is: Safe. Noninvasive. Inexpensive. Effective in dental caries management, especially arresting cavitated caries lesions in the primary dentition. Benefits of the research to the clinician: According to AAPD, 2017 SDF is: Easily performed. A promising strategy to manage dental caries in very young children or those who have special needs. Doesn't require cooperation from children during dental treatment. It will improve patient confidence with the dentist Explanation for choice of comparators: The use of sodium fluoride is well documented in the literature as successful caries arrestment material. Arrestment proportion of caries for sodium fluoride varnish was found to be 84.4% (NaF) and 85.3% for ( NaF + chlorohexidine mouth wash) .

Official Title
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Postoperative Pain After Application of Silver Diamine Fluoride Verses Sodium Fluoride Varnish in Treatment of Carious Primary Teeth (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 Hereditary developmental defects, such as amelogenesis imperfecta or dentinogenesis imperfecta Known allergies or sensitivities to dental materials, including SDF Inability to return for recall visits Refusal of participation from the guardian or parents

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 according to the allocation ratio
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 at 0,1,3,6, 9 and 12. SDF is a 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 patients 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 |
| --- | --- | --- |
| Postoperative Pain | Postoperative pain will be assessed through questioning the patient and/or parent .Binary (Yes or No) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental satisfaction | Parental satisfaction will be assessed through questioning the parent. Binary (yes or no) | 12 months | 
| Caries arrest (dentin texture) Cries arrest (Dentine texture) | Caries arrest will be assessed through tactile examination (hard or soft). Categorical | 12 months | 
| Discoloration (yellow, brown, black) | Discoloration will be assessed through visual examination. Categorical | 12 months |