This is a prospective, controlled, within-subject, randomized, single-center study comparing Scotchbond Universal Plus (SBU+) and Scotchbond Universal (SBU) adhesives when used with Filtek restorative. The study will enroll Subjects scheduled to undergo Class-V non-carious cervical lesion (NCCL) restorations.
This is a prospective, controlled, within-subject, randomized, single-center study that will enroll Subjects scheduled to undergo Class-V NCCL restorations on 2 or 4 teeth treated in pairs according to lesion depth. Enough subjects will be enrolled from a single site located in New Orleans, Louisiana, USA to perform a minimum of 110 restorations (estimated 38 subjects). Each study tooth will be restored using only one type of adhesive, either SBU+ or SBU, and Filtek restorative following manufacturer's directions using the "Total Etch/Etch and Rinse Procedure". Any teeth needing treatment that are not included in the study will be treated by the dentist using the standard of care. Subjects will be seen during screening (≤21 days before the restoration procedure), on the day of the restoration procedure, 7 days (± 3 days) after restoration (remote visit for subject self-assessment of baseline hypersensitivity), and follow-up visits at 6 months (± 14 days), 1 year (± 30 days), and 2 years (± 45 days) after restorations. Study teeth will be assessed for selected endpoints based partly on FDI (Fédération Dentaire Internationale) World Dental Federation criteria. Subjects may participate in additional unscheduled visits as required during the study if evaluation of any study tooth is required outside of the scheduled study visits. The entire duration of the study is expected to last approximately 3 years, with individual Subject participation expected to last up to 2 years (± 45 days). To help minimize or avoid bias in the study, randomization of study teeth will occur after teeth preparation but before the initial application of any adhesive. Assessments will be performed by 2 dental examiners that are independent of the dentist that placed the restorations and are blinded to the treatment arms. All examiners will be trained and calibrated for the scoring criteria before any Subject assessment occurs, and examiners will be retrained and recalibrated if any new evaluator is added to the list of assessors. After the second examiner has completed their assessments, the examiners will compare their evaluations and a consensus will be reached for each of the scoring criteria at each visit before the Subject leaves the visit. The consensus assessments will be entered into the Case Report Form (CRF).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
38
Eligible teeth with Class-V NCCLs randomized to the SBU+ treatment group underwent restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive using total-etch mode and Filtek Universal Restorative material.
Eligible teeth with Class-V NCCLs randomized to the SBU Control group underwent restoration(s) using Scotchbond Universal Plus (SBU) Adhesive using total-etch mode and Filtek Universal Restorative material.
Louisiana State University HSC-Health, School of Dentistry
New Orleans, Louisiana, United States
Retention of Restorative Material
The percentage of restorations with partial or complete loss of the restorative materials.
Time frame: 24 months post-restoration
Marginal Adaptation
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.
Time frame: 24 months post-restoration
Retention of Restorative Material
The percentage of restorations with partial or complete loss of the restoration material.
Time frame: 6 months post-restoration
Marginal Adaptation
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.
Time frame: 6 months post restoration
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Fracture of Restorative Material
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
Time frame: 6 months post-restoration
Secondary Caries
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.
Time frame: 6 months post-restoration
Retention of Restorative Material
The percentage of restorations with partial or complete loss of the restoration material.
Time frame: 12 months post-restoration
Marginal Adaptation
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.
Time frame: 12 months post-restoration
Fracture of Restorative Material
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
Time frame: 12 months post-restoration
Secondary Caries
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.
Time frame: 12 months post-restoration
Fracture of Restorative Material
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
Time frame: 24 months post-restoration
Secondary Caries
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.
Time frame: 24 months post-restoration