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The purpose of this study is to evaluate and compare the clinical performance of Silver diamine Fluoride+Potassium Iodide (SDF+KI) and Silver-Modified Atraumatic Restorative Technique (SMART/SDF+KI+GIC) on molars with MIH
SDF+KI and SMART (SDF+KI+GIC) were placed on two permanent molar teeth with MIH, in a split mouth design. 48 patients were included in the study. The teeth were randomized into two groups according to the dental restorative material.
Group 1: SDF+KI (Riva Star), Group 2: SDF+KI (Riva Star) +GIC (Equia Forte). The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) was used for clinical evaluation of atraumatic resin restorations. The restorations were evaluated at baseline and 1., 6., 12., 18., 24. months. Intra-oral photos were taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.
Fisher's Exact test, Kaplan-Meier Survival Curves, Log-rank test, Mann Whitney U test, and Friedman test was performed for the statistical analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDF+KI | Experimental | SDF+KI will be applied on molars with MIH |
|
| SMART(SDF+KI+GIC) | Active Comparator | SDF+KI+GIC will be applied on molars with MIH |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SDF+KI | Device | Molar with MIH will be treated with SDF+KI |
| |
| SDF+KI+GIC(SMART) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical performance of SDF+KI and SMART(SDF+KI+GIC) on molars with MIH | The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of atraumatic resin restorations. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zafer Cehreli | Hacettepe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University | Ankara | 06100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38797490 | Derived | Erbas Unverdi G, Ballikaya E, Cehreli ZC. Clinical comparison of silver diamine fluoride (SDF) or silver-modified atraumatic restorative technique (SMART) on hypomineralised permanent molars with initial carious lesions: 3-year results of a prospective, randomised trial. J Dent. 2024 Aug;147:105098. doi: 10.1016/j.jdent.2024.105098. Epub 2024 May 24. | |
| 34743243 |
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IPD is available from the corresponding author on reasonable request
Starting 6 months after publication
IPD is available from the corresponding author on reasonable request.
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D000094604 | Molar Hypomineralization |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D000094603 | Dental Enamel Hypomineralization |
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Two materials on two molars in one patient
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| Device |
Molar with MIH will be treated with SDF+KI+GIC(SMART) |
|
| Ballikaya E, Unverdi GE, Cehreli ZC. Management of initial carious lesions of hypomineralized molars (MIH) with silver diamine fluoride or silver-modified atraumatic restorative treatment (SMART): 1-year results of a prospective, randomized clinical trial. Clin Oral Investig. 2022 Feb;26(2):2197-2205. doi: 10.1007/s00784-021-04236-5. Epub 2021 Nov 6. |
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |