Management of Occlusal Caries Using Silver Modified Atraumatic Restorative Treatment Versus Atraumatic Restorative Treatment

Study Overview
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Brief Summary
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Silver modified atraumatic restorative treatment (intervention) or atraumatic restorative treatment (Control) will be used to manage occlusal caries in preschool children then the molars will be evaluated at the interval of 3,6 and 12 months clinically and 6 and 12 months radiographically

Detailed Description
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Aim of the study: To evaluate the clinical and radiographic outcomes after the use of silver modified atraumatic restorative treatment versus atraumatic restorative treatment in the management of occlusal caries in primary molars in preschool children. PICO: Population: Preschool children (4-6 years) with occlusal caries in second primary molars. Intervention: Silver modified atraumatic restorative treatment Comparator/Control: Atraumatic restorative treatment. Outcomes: Pain (provoked or spontaneous) OHRQoL(oral health related to quality of life) Parental esthetic perception Failure of restoration Caries density in radiograph Time: 3, 6 and 12 months Study design: A randomized clinical trial

Official Title
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Clinical and Radiographic Evaluation After the Use of Silver Modified Atraumatic Restorative Treatment Versus Atraumatic Restorative Treatment in the Management of Occlusal Caries of Primary Molars in Preschool Children: Randomized Clinical Trial

Conditions
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Occlusal Caries

Intervention / Treatment
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* Drug: Silver modified atraumatic restorative treatment
* Other: Atraumatic restorative treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patient and parent cooperation and compliance. Children aged 4 - 6 years Second primary molars with occlusal caries. No clinical signs and symptoms of pulp involvement No radiographic abnormalities Exclusion Criteria: • Uncooperative children or parents Children with systemic diseases Children with previous allergies to any of the used materials

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: Silver modified atraumatic restorative treatment<br>Using silver diamine fluoride incorporated with atraumatic restorative treatment | Drug: Silver modified atraumatic restorative treatment<br>* Silver diamine fluoride that will be applied during atraumatic restorative treatment<br>|
| Active Comparator: Atraumatic restorative treatment<br>Using atraumatic restorative treatment without the application of silver diamine fluoride | Other: Atraumatic restorative treatment<br>* Using atraumatic restorative treatment without applying silver diamine fluoride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questioning parent about whether the child have pain between follow up intervals (provoked or spontaneous) | Pain reported-Pain history that occurs after treatment at any point (will be recorded at the follow up intervals) Outcome will be binary (yes/no) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OHRQoL(oral health related to quality of life) | The Early Childhood Oral Health Impact Scale (A-ECOHIS) Score 0-52. There will be 13 questions each question with a score 0-5 where 0 = excellent, 1=very good, 2=good, 3=fair , 4=poor and 5= unknown so the less the score the better is the oral health related to quality of life. | 3 months | 
| Questioning parents about their aesthetic perception | Parent reported (parent is asked whether he/she is accepting the tooth appearance or not) Outcome will be binary (yes/no) | 3 months | 
| ART assessment criteria (Codes 00-90) | Failure of restoration according to the code in the ART assessment criteria (Codes 00-90). Code 00 or 10 are considered successful, codes 11-40 are classified as failures, and codes 50-90 are assigned in case the tooth was unavailable for evaluation | 12 months | 
| Caries density in radiograph | Pixel grey value | 12 months |