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To evaluate the clinical performance of High-Viscosity Glass Ionomer (EQUIA) versus Silver Diamine Fluoride combined with Potassium Iodide (Riva Star) and Sliver Diamine Fluoride (SDF) under High-Viscosity Glass Ionomer (EQUIA) in deep class I carious lesions, over a period of one year follow-up. The null hypothesis tested in this study, that in deep class I carious lesions, the High-Viscosity Glass Ionomer (EQUIA) versus Silver Diamine Fluoride combined with Potassium Iodide (Riva Star) and Sliver Diamine Fluoride (SDF) under High-Viscosity Glass Ionomer (EQUIA) will show the same clinical performance.
A sample of adults with an age range of 18-40 years old, having a permanent molar with deep class I carious lesions, according to the international caries detection and assessment system (ICDAS), occlusal caries that scored 4 (underlying dark shadow from dentin), or 5 (Distinct cavity with visible dentin), will be selected from the patients attending at the Conservative and Esthetic Dentistry Department Clinic, Faculty of Dentistry, Cairo University, and those who meet the study inclusion criteria will be recruited.
All selected 42 permanent molars will be randomly equally allocated into three groups according to the material used. Group I (n=14) Silver Diamine Fluoride combined with Potassium Iodide (Riva Star) under High-Viscosity Glass Ionomer (EQUIA), Group II (n=14) Silver Diamine Fluoride (SDF) both under High-Viscosity Glass Ionomer (EQUIA), and Group III (n=14) High-Viscosity Glass Ionomer (EQUIA).
Steps in Short:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention 1 | Experimental | Silver Diamine Fluoride combined with Potassium Iodide (Riva Star), under High-Viscosity Glass Ionomer (EQUIA). |
|
| Intervention 2 | Experimental | Silver Diamine Fluoride (SDF), under High-Viscosity Glass Ionomer (EQUIA). |
|
| The comparator | Active Comparator | High-Viscosity Glass Ionomer (EQUIA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver Diamine Fluoride combined with Potassium Iodide. | Other | Riva Star, Silver diamine fluoride 38% and potassium iodide, SDI, Bayswater, Australia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biological Properties: (Postoperative hyper-sensitivity) | will be ranked according to Federation Dentaire Internationale criteria (FDI). Scoring system (1,2,3,4,5) by patient interviewing | 12 Months. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Properties: (Radiographic examination and Patient's view) (Radiographic examination, and Patient's view) | will be ranked according to Federation Dentaire Internationale criteria (FDI). Scoring system (1,2,3,4,5) by standardized periapical digital radiographs taken by parallel technique and by patient interviewing | 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shorouk H Helmy, Master's | Contact | 00201015775110 | shorouk.helmy@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Shorouk H Helmy | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty Of Dentistry, Cairo University | Recruiting | Cairo | Egypt |
after 1 year.
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D011193 | Potassium Iodide |
| C024633 | silver diamine fluoride |
| ID | Term |
|---|---|
| D007454 | Iodides |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D017680 | Potassium Compounds |
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A 3-arm randomized clinical trial. Randomization will be done according to a check list including the number of participants divided into 3 groups of 14 patients (42 total) according to interventions/Control assessment methods.
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The operator will not be blinded due to differences between both materials.
|
| Silver Diamine Fluoride. | Other | A clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride. |
|
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| High-Viscosity Glass Ionomer. | Other | A Glass Hybrid material. |
|
|
| Esthetic: Tooth Color |
by Easy Shade. measuring unit: ΔE |
| 12 months. |