The Efficiency and Gingival Health Status of Hall Versus SDF Techniques in the Management of Carious Primary Molars

Study Overview
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Brief Summary
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PICO question: In Comparison to the hall technique , will silver diamine fluoride have equalvent gingival health status in treatment of carious primary molars? population: children suffering from caries . intervention : silver diamine fluoride. comparison: hall technique outcome: Primary outcome: Gingival health measurement device modified gingival index, measurement unit score(0-1-2) Secondary outcomes: Oral hygiene measurement device modified plaque index , measurement unit score (0-1-2) Time of Treatment measurement device digital chronometer, measurement unit minutes

Detailed Description
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Dental caries, also known as tooth decay, it can occur in primary teeth in early childhood, is formed through interaction between acid-producing bacteria and carbohydrate. The caries develops in both the crowns and roots of teeth. Progress of caries depended on the lifestyle of the child (as high numbers of cariogenic bacteria, inadequate salivary flow, insufficient fluoride exposure and poor oral hygiene). To avoid this disease should follow the proper oral hygiene and improve lifestyle . A lot of methods found to treatment the decayed tooth - like; Hall technique and Silver diamine fluoride 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 Previous studies have recommended that Silver diamine fluoride (SDF) solution would 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 objective is useful in arresting early childhood caries (ECC)

Official Title
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The Efficiency and Gingival Health Status of Hall Versus SDF Techniques 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: Age: From 4 to 6 years Clinical diagnosis of tooth with caries in primary molars within enamel or dentin without pulp disease Exclusion Criteria: Tooth with signs and symptoms of pulp necrosis Tooth with Root caries Tooth with 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: control group<br>The group that have caries in primary molars and treat them with 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>|
| Experimental: experimental group<br>the group that have caries in primary molars and treat them with silver diamine fluoride (SDF) solution would exert a prevention result in managing early childhood caries ECC | Drug: Silver diamine fluoride<br>* Previous studies have recommended that Silver diamine fluoride (SDF) solution would 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 objective is useful in arresting early childhood caries (ECC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival health | Modified Gingival index (0 = no swelling = mild swelling, no bleeding after gentle probing = moderate to severe gingival swelling, bleeding after air drying | up to 1 day | 
| Gingival health | Modified Gingival index (0 = no swelling = mild swelling, no bleeding after gentle probing = moderate to severe gingival swelling, bleeding after air drying | at 3 months | 
| Gingival health | Modified Gingival index (0 = no swelling = mild swelling, no bleeding after gentle probing = moderate to severe gingival swelling, bleeding after air drying | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral hygiene | Modified Plaque index(0 = no plaque = thin visible plaque, difficult to identify = thick visible plaque, easily detected | up to one day | 
| Oral hygiene | Modified Plaque index(0 = no plaque = thin visible plaque, difficult to identify = thick visible plaque, easily detected | at 3 months | 
| Oral hygiene | Modified Plaque index (0 = no plaque = thin visible plaque, difficult to identify = thick visible plaque, easily detected | at 6 months | 
| Treatment time | Digital chronometer | during procedure | 
| Treatment time | Digital chronometer | during procedure in the second application at 6 monthes |