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The aim of the study is to compare preformed metal crowns and 3D-printed ceromer crowns in primary molars of 4-9 years old children. The main questions it aims to answer are:
Study methodology:
This study is a split-mouth clinical trial where participants will receive at least one of each materials in different quadrants of the mouth.
This randomized clinical trial is designed following the Consolidated Standards of Reporting Trials (CONSORT) guidelines and will adopt a prospective, split-mouth approach. The objective is to compare the clinical performance of crowns fabricated with three-dimensional (3D) printed ceromer material against conventional preformed stainless steel crowns in extensively decayed primary posterior teeth. The unit of observation will be gingival inflammation in the area surrounding the restorations, evaluated at specific time points over a 12-month follow-up period (3, 6 and 12 months).
Each eligible participant will receive both types of crowns, with assignments made to contralateral quadrants of the mouth to allow for within-subject comparison. This methodology minimizes inter-individual variability and strengthens internal validity. The ceromer crowns will be fabricated via additive manufacturing (3D printing), while the stainless steel crowns will follow the conventional selection and crimping technique.
Written informed consent will be obtained from their guardians or parents. An expected total of 50 primary molars of healthy participants will be restored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D-printed ceromer crown | Experimental | Group A: 3D-printed ceromer crown (Sculpture, Rodin Resins, La Brea, CA, USA) |
|
| Stainless steel crown | Active Comparator | Group B: Stainless steel crown (3M Espe, Saint Paul, MN, USA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized 3D-printed pediatric ceromer crown | Procedure | After primary molar crown preparation, digital impression using intraoral scanner (i700, Medit, Seoul, South Korea), crown will be designed with CAD software (CliniCAD, medit, South Korea) and fabricated using a 3D printer, (Sonic mini 4k, Phrozen, Taipei, Taiwan). Crown will be cemented by passive seating using a self-adhesive dual cure cement (Beauticem, shofu, San Marcos, CA, USA) |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index (PI) (Silness and Loe, 1964) | 0- No plaque in the area adjacent to the gingiva
| 12 months |
| Gingival Index (GI) (Loe & Silness, 1963) | 0- Healthy gingiva, no inflammation
| 12 months |
| International Dental Federation (FDI) criteria used for clinical evaluation of indirect restorations | Functional, Biological and Esthetic properties, scored from 1-5 (higher score meaning worse result. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | A 5 question satisfaction questionnaire with 5 point lykert scale questions | 6 months |
| Parental satisfaction | A 5 question satisfaction questionnaire with 5 point lykert scale questions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alan Velazquez, DDS, MPH | Contact | +526644622237 | avelazquez81@uabc.edu.mx | |
| Sibelli Olivieri, DDS, PhD | Contact | +5543999750266 | sibelli.olivieri@uabc.edu.mx |
| Name | Affiliation | Role |
|---|---|---|
| Alan Velazquez, DDS, MPH | Universidad Autonoma de Baja California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facultad de OdontologÃa | Tijuana | Estado de Baja California | 22427 | Mexico |
IPD will be shared to with
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Due to the esthetic nature of the different materials, masking of the participants and investigators is not possible, however outcomes assessor with be masked.
|
| Prefabricated stainless steel crown group | Device | Stainless steel crown application: After preparation of the tooth, the crown will be filled and cemented with type-1 glass ionomer cement (Ketac Cem easymix, 3M ESPE, Minnesota, USA) |
|
| 6 months |