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The purpose of this study is to evaluate and compare the clinical performance of Giomer and GIC restorations with and without SDF on caries sealing of primary molar teeth
Restorations will be placed on four primary molar teeth with occlusal caries, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into four groups according to the restorative materials.
Group 1: SDF (Riva Star) + Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 2: Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 3: SDF (Riva Star) + GIC (Equia Forte, GC, Japan) Group 4: GIC (Equia Forte, GC, Japan)
The restorations will be evaluated clinically at baseline and 6., 12., 18., 24. months and radiologically at 6., 12. and 24. months. The modified US Public Health Service criteria (secondary caries, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of restorations. Intra-oral photos will be taken directly after treatment and at control appointments.
The data will be analysed statistically using Wilcoxon test, chi square test and the Kaplan-Meier survival method will be used to estimate survival percentages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDF+Giomer | Experimental | Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Beautifil II restorative material |
|
| Giomer only | Experimental | Beautifil II dental restorative material |
|
| SDF+GIC | Experimental | Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Equia forte |
|
| GIC only | Experimental | Equia forte dental restorative material |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SDF | Device | Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The US Public Health Service criteria for secondary caries on restorations | A:There is no clinical diagnosis of caries C:There is clinical diagnosis of caries | 2 years |
| The US Public Health Service criteria for retention of restorations | Alpha: No loss on the restoration Bravo:Partial loss on the restoration Charlie:Total loss on the restoration | 2 years |
| The US Public Health Service criteria for marginal discoloration on restorations | Alpha: No visual evidence of discoloration Bravo: Slight staining which can be polished away Charlie: Discoloration has penetrated in the pulpal direction | 2 years |
| The US Public Health Service criteria for marginal adaptation on restorations | Alpha: Restoration is fully intact. No explorer catch evident Bravo: Slight explorer catch in no more than 1/3 of margins Charlie: Explorer catch and/or penetration is evident in more than 1/3 of restoration margin | 2 years |
| The US Public Health Service criteria for surface roughness on restorations | Alfa: Enamel-like surface Bravo: Surface rougher than enamel, clinically acceptable Charlie: Surface unacceptably rough / restoration is broken or cracked | 2 years |
| The US Public Health Service criteria for anatomical form on restorations | A: No loss on anatomical form of the restoration B: Change in anatomical form but dentin or cement is not expose C: Change in anatomical form that expose dentin or cement | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zafer C Cehreli | Contact | 00905353197969 | zcehreli@gmail.com | |
| Gizem Erbas Unverdi | Contact | 00905052805736 | erbasgizem@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Zafer Cehreli | Hacettepe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University | Recruiting | Ankara | 06100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Giomer | Device | Beautifil II dental restorative material |
|
| GIC | Device | Equia forte dental restorative material |
|
| Hacettepe university | Recruiting | Ankara | 06100 | Turkey (Türkiye) |
|