Oral Health-Related Quality of Life of Early Childhood Caries Using Silver Diamine Fluoride Versus Drill and Fill Technique

Study Overview
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Brief Summary
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The clinical trial aims to compare children's oral health-related quality of life (OHrQL) following caries arrest technique using SDF versus conventional drill and fill in the children with ECC

Detailed Description
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Early childhood caries (ECC) has been an increasing issue in many countries and has become a significant health problem, especially in socially disadvantaged populations. ECC is a specific form of caries that occurs in children with primary teeth. ECC is characterized as the early onset of caries in young children with often fast progression which can finally result in complete destruction of the primary dentition. Management of cavitated carious lesions in primary teeth in very young children is time-consuming due to their lack of cooperation, so one of the alternative procedures could be performed with silver diamine fluoride (SDF), to its effectiveness in arresting the activity of carious lesions (cavitated and non-cavitated). It is easy to apply even outside dental offices, and relatively inexpensive solutions can be used particularly when compared to restorative intervention.

Official Title
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Evaluation Of Changes in Children's Oral Health-Related Quality of Life Following Treatment of Early Childhood Caries With Caries Arrest Technique Using Silver Diamine Fluoride Versus Conventional Drill and Fill Technique A Randomized Clinical Trial

Conditions
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Oral Health Related Quality of Life, Early Childhood Caries

Intervention / Treatment
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* Other: silver diamine fluoride
* Other: conventional composite resin restoration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children Aged 3 to 5 years, in good general health and medically within normal. The parents provided written informed consent. Carious vital primary molars with reversible pulpitis. Restorable teeth. Normal Radiographic findings. Exclusion Criteria: Unable to attend follow-up visits. Refusal of participation. Previously accessed teeth.

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
Interventional Model Description: for both the intervention group and control group, the procedure and follow up will be done parallel to each other
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: silver diamine fluoride<br> | Other: silver diamine fluoride<br>* silver diamine fluoride is a colorless with high PH topical fluoride solution of 38% weight/volume use for arresting early childhood caries<br>Other: conventional composite resin restoration<br>* Dental composite resins are dental cement made of synthetic resins which were insoluble, of good tooth-like appearance, insensitive to dehydration, and easy to manipulate.<br>|
| Active Comparator: conventional composite resin restoration<br> | Other: silver diamine fluoride<br>* silver diamine fluoride is a colorless with high PH topical fluoride solution of 38% weight/volume use for arresting early childhood caries<br>Other: conventional composite resin restoration<br>* Dental composite resins are dental cement made of synthetic resins which were insoluble, of good tooth-like appearance, insensitive to dehydration, and easy to manipulate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Health to Quality of Life | will be evaluated by a questioner answered by the parents | 6 month intervene | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cost effectiveness | will be measured using ICER (incremental cost-effectiveness ratio) | 6 month intervene | 
| Parental satisfaction | will be measured by Direct questioning to the parents. | 6 month intervene | 
| Side effects | will be measured by Direct questioning to the parents. | 6 month intervene | 
| Time of the procedure | will be measured by stopwatch | 6 month intervene | 
| Postoperative pain and sensitivity | will be measured by Visual analogue scale | 6 month intervene |