Staining Potential and Caries Arresting Effect of Silver Diamine Fluoride⁄Potassium Iodide and Silver Diamine Fluoride

Study Overview
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Brief Summary
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the main objective of this study is to evaluate staining potential and Caries Arresting Effect of silver diamine fluoride⁄potassium Iodide and silver diamine fluoride in carious anterior primary teeth

Detailed Description
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Despite increased attention on caries prevention, not all children receive preventive treatments and large numbers still experience tooth decay. Primary care providers have had little option other than invasive and costly specialist treatment in the hospital under general anesthesia. In this context, there is interest in simple treatments to halt progress of carious lesions after tooth decay onset. Among these simple treatments is silver diamine fluoride (SDF) treatment. The major drawback to SDF treatment has been its black staining, which has limited its use. To counter the staining, researchers have tested SDF treatment immediately followed with application of saturated solution of potassium iodide (KI).

Official Title
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Comparative Evaluation of Staining Potential and Caries Arresting Effect of Silver Diamine Fluoride⁄Potassium Iodide and Silver Diamine Fluoride in Carious Primary Anterior Teeth

Conditions
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Dental Caries in Children

Intervention / Treatment
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* Drug: silver diamine fluoride ⁄ potassium Iodide
* Drug: Silver Diamine Fluoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with carious primary anterior teeth. Children with no spontaneous pain Exclusion Criteria: Tooth mobility Signs of pulpal or periapical infection Severe medical conditions that would not allow management in the clinic Sensitivity to silver or other heavy-metal ions Presence of any gingival or perioral ulceration or stomatitis

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: silver diamine fluoride ⁄ potassium Iodide<br>38% silver diamine fluoride and a saturated solution of potassium iodide | Drug: silver diamine fluoride ⁄ potassium Iodide<br>* The affected tooth surface will be gently cleaned and dried with cotton gauze. The gingival tissue of the tooth will be protected with petroleum jelly. An applicator will be dipped into the SDF and 3-4 mg applied to the lesion with microbrush which will be used to paint solution over carious lesion then we will wait for 1 minute till absorption . Then after SDF application KI will be applied using a separate microbrush which will be saturated by the solution and will be used to paint solution over carious lesion , no rinse will be performed and special instructions will be given following application<br>* Other names: SDF / KI;|
| Active Comparator: silver diamine fluoride<br>38% silver diamine fluoride | Drug: Silver Diamine Fluoride<br>* The affected tooth surface will be gently cleaned and dried with cotton gauze. The gingival tissue of the tooth will be protected with petroleum jelly. An applicator will be dipped into the SDF and 3-4 mg applied to the lesion with microbrush which will be used to paint solution over carious lesion then we will wait for 1 minute till absorption .<br>* Other names: SDF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| staining potential | change in color of carious lesion using spectrophotometer with unit of measurement percent | base line and Immediately after material application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| caries arresting effect | evaluating hardness of carious lesion by tactile examination using probe, binary (soft or hard) | 3 months, 6 moths, 9 months, 12 months |