Trial Outcomes & Findings for Scotchbond Universal Plus Compared to Scotchbond Universal With Filtek Universal Restorative to Restore Class V NCCLs (NCT NCT05361746)

The patient population was selected from current patients under clinical treatment at Louisiana State University (LSU), School of Dentistry. Patients were between the ages of 18 and 70 years old at time of consent, of either sex, and of any ethnic background. Eligible patients needed to have at least two teeth with Class V non-carious cervical lesions (NCCL) at least 1.5 mm deep, in vital teeth that had not undergone root canal treatment.

Subjects were required to meet all inclusion and none of the exclusion criteria to be eligible. A total of 38 subjects were screened and of those, 32 subjects were treated. Two or four Class V restorations were placed per patient, randomized in a 1:1 ratio with half of the teeth (i.e., 1 tooth for Subjects with 2 eligible teeth, or 2 teeth for Subjects with 4 eligible teeth) randomized to the SBU+ Adhesive Treatment group and the other half to the SBU Adhesive Control group.

Unit of analysis: Restorations

One subject withdrawn by the IRB was not included in the full analysis set.

The percentage of restorations with partial or complete loss of the restorative materials.

Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI (Fédération Dentaire Internationale) World Dental Federation criteria. Scoring categories for marginal adaptation: 1. Excellent/very good: No clinically detectable gap. 2. Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing. 3. Sufficient/Satisfactory: Leakage/discoloration is present but limited to the marginal area. 4. Unsatisfactory: Localized gap larger than 250 µm, may result in exposure of dentine or base. 5. Poor: Generalized gap larger than 250 µm or the restoration is loose but in situ, re-placement necessary.

The percentage of restorations with partial or complete loss of the restoration material.

Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for marginal adaptation: 1. Excellent/very good: No clinically detectable gap. 2. Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing. 3. Sufficient/Satisfactory: Leakage/discoloration is present but limited to the marginal area. 4. Unsatisfactory: Localized gap larger than 250 µm, may result in exposure of dentine or base. 5. Poor: Generalized gap larger than 250 µm or the restoration is loose but in situ, re-placement necessary.

Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for the fracture of restorative material are defined as follows: 1. Excellent/very good: No fractures/cracks 2. Good: Small hairline cracks 3. Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact 4. Unsatisfactory: Material chip fractures which damage marginal quality or approximal contacts

Secondary caries in study teeth scored on scale 1-5. 1. Excellent/Very Good: No secondary or primary caries 2. Good: Small and localized areas of demineralization 3. Sufficient/Satisfactory: Larger areas of demineralization 4. Unsatisfactory: Caries with cavitation and suspected undermining caries 5. Poor: Deep caries or exposed dentin not accessible for repair of restoration.

The percentage of restorations with partial or complete loss of the restoration material.

Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for marginal adaptation: 1. Excellent/very good: No clinically detectable gap. 2. Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing. 3. Sufficient/Satisfactory: Leakage/discoloration is present but limited to the marginal area. 4. Unsatisfactory: Localized gap larger than 250 µm, may result in exposure of dentine or base. 5. Poor: Generalized gap larger than 250 µm or the restoration is loose but in situ, re-placement necessary.

Fractures on study teeth graded on a 1-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for the fracture of restorative material are defined as follows: 1. Excellent/very good: No fractures/cracks 2. Good: Small hairline cracks 3. Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact 4. Unsatisfactory: Material chip fractures which damage marginal quality or approximal contacts

Secondary caries in study teeth graded on a 1-5 grading scale with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for secondary caries are defined as follows. 1. Excellent/Very Good: No secondary or primary caries 2. Good: Small and localized areas of demineralization 3. Sufficient/Satisfactory: Larger areas of demineralization 4. Unsatisfactory: Caries with cavitation and suspected undermining caries 5. Poor: Deep caries or exposed dentin not accessible for repair of restoration.

Fractures on study teeth graded on a 1-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for the fracture of restorative material are defined as follows: 1. Excellent/very good: No fractures/cracks 2. Good: Small hairline cracks 3. Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact 4. Unsatisfactory: Material chip fractures which damage marginal quality or approximal contacts

Secondary caries in study teeth graded on a 1-5 grading scale with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for secondary caries are defined as follows. 1. Excellent/Very Good: No secondary or primary caries 2. Good: Small and localized areas of demineralization 3. Sufficient/Satisfactory: Larger areas of demineralization 4. Unsatisfactory: Caries with cavitation and suspected undermining caries 5. Poor: Deep caries or exposed dentin not accessible for repair of restoration.