Parental Satisfaction of Hall Technique Versus SDF in the Management of Carious Primary Molars

Study Overview
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Brief Summary
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The aim of this study is to assess parental satisfaction and duration of the procedure of Hall and silver diamine fluoride techniques in the treatment of carious primary molars with healthy pulp. primary ourcome: parental satisfaction measurement device: four point likert scale measurement unit: 1-2-3-4 secondary outcome: duration of the procedure measurement device: Digital chronometer measurement unit: minutes

Detailed Description
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dental caries is a critical disease that affects primary teeth in early childhood. It occurs through interaction between acid-producing bacteria and carbohydrates on tooth surface. progression of caries depends on several factors such as type of diet, oral hygiene, cariogenic bacterial load and salivary flow. to control caries, the life style of a child should be improved by having healthy non-cariogenic diet and proper oral hygiene. caries can be treated by advanced non-invasive methods such as: Hall technique and Silver diamine fluoride which are based on controlling the acidic medium of a cariogenic biofilm without removal of caries thus, arresting the progression of demineralization and restoring the function of diseased molars. The first report on Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique through a more simplified method. Previous studies have recommended silver diamine fluoride (SDF) to arrest early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. The trial is seeking the measurement of effectiveness of two modalities (Hall & SDF techniques) to achieve best acceptable treatment for caries in developing countries which have high caries index.

Official Title
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Parental Satisfaction of Hall Technique Versus Silver Diamine Fluoride (SDF) in the Management of Carious Primary Molars Randomized Clinical Trial

Conditions
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Caries

Intervention / Treatment
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* Drug: Silver diamine fluoride
* Device: Hall technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1 age: from 4 to 6 years old 2 primary molars with enamel/dentin caries without pulp exposure Exclusion Criteria: 1 signs and symptoms of necrosis 2 root caries 3 spontaneous pain

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hall technique<br>group of carious primary molars to be treated by hall technique | Device: Hall technique<br>* The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method<br>* Other names: HT;|
| Experimental: silver diamine fluoride<br>group of carious primary molars to be treated by silver diamine fluoride | Drug: Silver diamine fluoride<br>* Previous studies have recommended silver diamine fluoride (SDF) to exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. The result is useful in arresting early childhood caries (ECC)<br>* Other names: SDF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parental satisfaction of Hall technique versus silver diamine fluoride | To estimate parental satisfaction with treatment, parents are going to be asked, What's the level of your satisfaction with the treatment your child received? Using a 4 point likert scale (very low equals 1, low equals 2, medium equals 3 and high equals 4) | during procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment time | Time will be measured from the start of the procedure till its end using digital chronometer as a device and minutes as a unit. | during procedure |