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The aim of this study is to evaluate the 18-month clinical performance of a multimode adhesive (Scotchbond Universal Adhesive, 3M ESPE, St Paul, MN, USA) in primary molars after partial carious removal. This randomized clinical trial will include subjects (5-10 year-old children) selected at two university centers (UFSM and FOUSP). The sample will consist of 132 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal and occlusal-proximal surface. The sample will be randomly divided into two groups according to bonding approach: etch-and-rinse or self-etch strategy. The restorations will be clinically followed every 6 months for up to 18 months using the USPHS modified criteria for clinical evaluation. Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier method.
Randomized clinical trials of performance of universal adhesive in primary molars
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-etch approach | Experimental | Application of universal adhesive as self-etch mode |
|
| Etch-and-rinse approach | Experimental | Application of universal adhesive as etch-and-rinse mode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-etch approach | Other | The adhesive will be vigorously agitated on the entire enamel and dentin surfaces for 20 seconds, according to the manufacturer's recommendations.The brush will be scrubbed on the dentin surface under manual pressure followed by gentle air thinning for five seconds and finally light curing for 10 seconds. |
| Measure | Description | Time Frame |
|---|---|---|
| Longevity of restoration | The outcome of the study is the failure of restorations in primary teeth. Failures will be assessed by clinical evaluation and will be considered in the presence of loss of restoration or fracture requiring a reintervation (restoration repair or replacement) or symptoms requiring pulp intervention or tooth extraction. | 18-month follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Rocha, Professor | Contact | +55 55 3220 9266 | rachelrocha@smail.ufsm.br |
| Name | Affiliation | Role |
|---|---|---|
| Rachel Rocha, Professor | Universidade Federal de Santa Maria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Santa Maria | Recruiting | Santa Maria | Rio Grande do Sul | 97015372 | Brazil |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 16, 2016 | |
| Reset | Jan 11, 2017 | |
| Release | May 17, 2022 | |
| Reset | Feb 16, 2023 | |
| Release | Mar 24, 2025 | |
| Reset | Apr 9, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 16, 2016 | Jan 11, 2017 | |||
| May 17, 2022 |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Etch-and-rinse approach | Other | After acid etching for 15 seconds, the sound and caries-affected dentin will be kept moist.The adhesive will be vigorously agitated on the entire enamel and dentin surfaces for 20 seconds, according to the manufacturer's recommendations.The brush will be scrubbed on the dentin surface under manual pressure followed by gentle air thinning for five seconds and finally light curing for 10 seconds. |
|
| Feb 16, 2023 |
| Mar 24, 2025 | Apr 9, 2025 |