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Aim: This randomized controlled clinical study aimed to compare direct composite resin restorations and Computer Aided Design-Computer Aided Manufacturing (CAD-CAM) supported inlay or onlay restorations in young permanent molar teeth with hypomineralization.
The main questions aim to answer are:
Materials and method: Children aged 6-14 years old without any systemic conditions with 32 first and second hypomineralized permanent molar teeth were included in the study. Patients were randomly distributed into 2 groups as direct composite resin restorations and CAD-CAM supported inlay or onlay restorations. All restored teeth were evaluated clinically and radiographically for 24-months. Statistical significance was accepted as p<0.05.
After randomization and local anesthesia administration, caries removal and preparation were completed under rubber-dam isolation. After preparation, 60 seconds of orthophosphoric acid, 60 seconds of 5% sodium hypochlorite and 30 seconds of orthophosphoric acid steps were applied before bonding agent and composite resin restorations. On the other hand, the preparation was completed by making a bevel on the enamel surfaces and a nanohybrid ceramic material used for the manufacturing CAD-CAM supported inlay or onlay restorations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Composite resin (Filtek Z250, 3M ESPE) | Active Comparator | A pretreatment protocol including sodium hypochlorite and ortho-phosphoric acid was applied to the tooth surface. Then, the tooth was restored with a composite resin material (Filtek Z250, 3M ESPE). This protocol is a clinically approved way for restoring hypomineralized teeth. |
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| CAD-CAM supported (Cerasmart, GC Dental) | Experimental | The preparation was completed by making bevels on the enamel surfaces. Then, an intraoral impression was taken to sent to the laboratory for manufacturing CAD-CAM-supported restoration with a nanohybrid ceramic material (Cerasmart, GC Dental). CAD-CAM supported restorations can be done by using a lot of restorative blocks by milling them. In this study, we preferred using resin-based blocks (Cerasmart, GC Dental) to compare with the control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tooth restoration | Other | Comparison of composite resin and CAD-CAM supported restorations for hypomineralized molar teeth in children |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation (Modified USPHS criteria- Anatomic form) | Anatomic form was examined by inspection at 3,6,12,18, and 24 months. | 24 months |
| Clinical evaluation (Modified USPHS criteria-Surface roughness) | Surface roughness was examined by inspection and probing at 3,6,12,18, and 24 months. | 24 months |
| Clinical evaluation (Modified USPHS criteria-Marginal adaptation) | Marginal adaptation was examined by inspection and probing at 3,6,12,18, and 24 months. | 24 months |
| Clinical evaluation (Modified USPHS criteria-Marginal discoloration) | Marginal discoloration was examined by inspection at 3,6,12,18, and 24 months. | 24 months |
| Clinical evaluation (Modified USPHS criteria-Retention) | Retention was examined by inspection and probing at 3,6,12,18, and 24 months. | 24 months |
| Clinical evaluation (Modified USPHS criteria-Color stability) | Color stability was examined by inspection at 3,6,12,18, and 24 months. | 24 months |
| Clinical evaluation (Modified USPHS criteria-Secondary caries) | Secondary caries was examined by inspection and probing at 3,6,12,18, and 24 months. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didem Sakaryalı Uyar, PhD MD, DDS | Başkent Universiry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Başkent University | Ankara | Cankaya | 06490 | Turkey (Türkiye) |
Information about patients might be requested from the principal author due to reasonable cause.
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| ID | Term |
|---|---|
| D000094604 | Molar Hypomineralization |
| ID | Term |
|---|---|
| D000094603 | Dental Enamel Hypomineralization |
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
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Observational clinical trial
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| Clinical evaluation (Modified USPHS criteria-Proximal contact) | Proximal contact was examined by inspection and probing at 3,6,12,18, and 24 months. | 24 months |
| Radiographical evaluation (Lamina dura) | Lamina dura continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months. | 24 months |
| Radiographical evaluation (Change in inter-root trabeculation continuity) | Change in inter-root trabeculation continuity was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months. | 24 months |
| Radiographical evaluation (Radiolucent area development) | Radiolucent area development in the inter-root area was evaluated by periapical radiographs taken at 6, 12, 18, and 24-months. | 24 months |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |