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After 24 months:
The null hypothesis of the study is that there is no statistically significant difference in the success of Class II resin restorations after their placement in primary molars, regardless of whether a pulpotomy has been performed or not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Class II composite restoration on primary teeth with pulpotomy | Active Comparator |
| |
| Class II composite restoration on primary teeth without pulpotomy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Class II restoration after pulpotomy | Procedure | The same dentist performs all restorations. All treatments are carried out using a rubber dam and the appropriate local anesthesia. After pulpotomy completion with a layer of MTA®, an intermediate layer of glass ionomer cement (Vitrebond Plus™) is placed before the final composite resin restoration. Class II resin restorations are performed after complete caries removal, placement of a partial matrix, etching with 37% phosphoric acid for 15 seconds, bonding with a 4th-generation adhesive agent (Prime n Bond NT, Dentsply™), and placement of composite resin (Filtek Universal™, 3M™). |
| Measure | Description | Time Frame |
|---|---|---|
| Modified USPHS criteria | Modified USPHS criteria are variations of the original United States Public Health Service criteria used in dentistry to clinically evaluate restorations. They include the following criteria: marginal adaptation, retention, marginal discoloration, and secondary caries, with specific parameters and scoring scales adjusted for a particular study or material being evaluated. These modifications allow for a more precise assessment of dental restorations by tailoring the evaluation to specific clinical situations or restorative materials | Assessment is done at 12 and 24 months following placement of the composite restoration |
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Inclusion Criteria:
Healthy children aged 3-9 years
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lygidakis Dental Clinic | Athens | 11528 | Greece |
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| Class II restoration without pulpotomy | Procedure | The same dentist performs all restorations. All treatments are carried out using a rubber dam and the appropriate local anesthesia. Class II resin restorations are performed after complete caries removal, placement of a partial matrix, etching with 37% phosphoric acid for 15 seconds, bonding with a 4th-generation adhesive agent (Prime n Bond NT, Dentsply™), and placement of composite resin (Filtek Universal™, 3M™). |
|
| ID | Term |
|---|---|
| D011672 | Pulpotomy |
| ID | Term |
|---|---|
| D004708 | Endodontics |
| D003813 | Dentistry |
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