Silver Diamine Fluoride Modified Restoration In Treating Hypomineralized First Permanent Molar.

Study Overview
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Brief Summary
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A randomized clinical trial to compare silver modified glass ionomer restorations to non silver glass ionomer restorations in hypo-mineralized first permanent molars in children and to measure the amount of wear of restoration in both groups along with detecting changes in hypersensitivity in hypomineralized molars in both groups after one year follow up.

Official Title
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Quantitative Evaluation of Silver Diamine Fluoride Modified Restoration In Treating Hypomineralized First Permanent Molar In A Group Of Children-A Clinical Study

Conditions
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Molar Incisor Hypomineralization

Intervention / Treatment
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* Other: Silver Diamine Fluoride 38%
* Other: fluoride varnish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral first permanent molars affected with molar incisor hypomineralization and with the same ICDAS II score. Both chosen molars should be of the same degree of MIH severity. Exclusion Criteria: signs and symptoms of irreversible pulpitis or pulp necrosis.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 9 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 |
| --- | --- |
| Active Comparator: Silver Diamine fluoride modified glass ionomer restoration<br> | Other: Silver Diamine Fluoride 38%<br>* silver diamine fluoride 38% brushed on the cavity for 1 minute before adding high viscosity glass ionomer restoration in one molar<br>|
| Active Comparator: fluoride varnish and glass ionomer restoration<br> | Other: fluoride varnish<br>* fluoride varnish brushed after adding the high viscosity glass ionomer restoration in the contralateral molar<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring surface wear using CAD-CAM software program | impressions were taken after treatment and after one year the two impressions were scanned. The scans were superimposed to compare the surface change. T o standardize the measurements specific selected points on the occlusal surface was used. | after 1 year | 
| Restoration Survival evaluation using the Atraumatic Restorative Treatment(ART) criteria | ART criterion was used to evaluate the restorations done after treatment then once again after one year. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tooth hypersensitivity was evaluated with Schiff cold air sensitivity scale (SCASS) | The molars that were selected for treatment were tested for hypersensitivity. The air was delivered from a standard dental unit air syringe for 1 second at a distance of 1 cm and perpendicular to the occlusal surface of the tooth, before treatment ,after 1 week, 6 months and 12 months. | after 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MIH, silver diamine fluoride, children, glass ionomer