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The aim of this study is to evaluate the clinical success of injectable composite versus packable composite in restoration of primary anteriors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injectable composite | Experimental | Injectable composite Beautifil flow Plus X (Shofu INC., Koyoto, Japan) |
|
| Packable Composite | Active Comparator | Packable Composite Beautifil II (Shofu INC., Koyoto, Japan) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injectable composite resin restoration | Biological | Injectable composite Beautifil flow Plus X (Shofu INC., Koyoto, Japan) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Direct Clinical Assessment of Restoration | Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Marginal integrity Measuring Device: Explorer Measuring unit: Alpha (A) There is no visible evidence of ditching along the margin of the restoration. Bravo (B) There is visible evidence of ditching along the margin of the restoration, it is not extending to the dentino-enamel junction. Charlie (C) There is dentin or base is exposed along the margin of the restoration. Delta (D) The restoration is mobile, fractured, or missing. | through study completion, on average of 1 year |
| Direct Clinical Assessment of Restoration | Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Color Match Measuring Device: Visual Inspection Measuring unit: Alpha (A) The restoration appears to match the shade and translucency of adjacent tooth tissues. Bravo (B)The restoration does not match the shade and translucency of adjacent tooth tissues, but the mismatch is within the normal range of tooth shades. Charlie (C)The restoration does not match the shade and translucency of the adjacent tooth structure, and the mismatch is outside the normal range of tooth shades and translucency | through study completion, on average of 1 year |
| Direct Clinical Assessment of Restoration | Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Cavo surface marginal discoloration Measuring Device: Visual Inspection Measuring unit: Alpha (A) There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure. Bravo (B) There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction. Charlie (C) There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction. | through study completion, on average of 1 year |
| Direct Clinical Assessment of Restoration |
| Measure | Description | Time Frame |
|---|---|---|
| Parents' patient Satisfaction | Measuring Device: Questionnaire Measuring unit: Binary (yes or No) | immediately after the intervention/procedure |
| Chair side time | Measuring Device: Stopwatch Measuring unit: Minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bassant Mohamed ElMesbahy | Contact | +201127132944 | bassant.elmesbahy@dentistry.cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Dentistry Department, Faculty of Dentistry, Cairo University | Cairo | Egypt |
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Patients will be recruited from outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry Cairo University. Patients will be carefully assessed for eligibility to participate in our study then a full explanation of the nature of our experiment will be provided for parents or guardian before obtaining the informed consent from them.
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| packable composite | Biological | Packable Composite Beautifil II (Shofu INC., Koyoto, Japan) |
|
Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Secondary Caries Measuring Device: Visual Inspection Measuring unit: Alpha (A) The restoration is a continuation of existing anatomic form adjacent to the restoration. Bravo (B) There is visual evidence of dark keep discoloration adjacent to the restoration (but not directly associated with cavosurface margins) |
| through study completion, on average of 1 year |
| Direct Clinical Assessment of Restoration | Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Anatomic Contour Measuring Device: Visual Inspection and Explorer Measuring unit: Alpha (A) Visual inspection and explorer The restoration is a continuation of existing anatomic form or is slightly flattened. It may be overcontoured. When the side of the explorer is placed tangentially across the restoration, it does not touch two opposing cavosurface line angles at the same time. Bravo (B) A surface concavity is evident. When the side of the explorer is placed tangentially across the restoration, it does not touch two opposing cavosurface line angles at the same time, but the dentin or base is not exposed. Charlie (C) There is a loss of restorative substance such that a surface concavity is evident and the base and/or dentin is exposed. | through study completion, on average of 1 year |
| Direct Clinical Assessment of Restoration | Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Surface Texture Measuring Device: Explorer Measuring unit: Alpha (A) Explorer Surface texture similar to polished enamel as determined by means of a sharp explorer. Bravo (B) Explorer Surface texture gritty or similar to a surface subjects to a white stone or similar to a composite containing supramicron-sized particles. Charlie (C) Explorer Surface pitting is sufficiently coarse to inhibit the continuous movement of an explorer across the surface. | through study completion, on average of 1 year |
| Direct Clinical Assessment of Restoration | Modified United States Public Health Service (USPHS) Ryge Criteria Outcome name: Gross Fracture Measuring Device: Visual Inspection Measuring unit: Alpha (A) Restoration is intact and fully retained. Bravo (B) Restoration is partially retained with some portion of the restoration still intact. Charlie (C) Restoration is completely missing. | through study completion, on average of 1 year |
| immediately after the intervention/procedure |
| Plaque accumulation | Measuring Device: Plaque index Score by Probe Measuring unit: 0 : No plaque
| through study completion, on average of 1 year |