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This research study is looking at a new bond-promoting substance (a dental adhesive called 3Mâ„¢ Scotchbondâ„¢ Universal Plus Adhesive) used between the tooth and dental restoration (filling). This is a randomized, split-mouth study designed to evaluate whether Scotchbondâ„¢ Universal Plus Adhesive (SBU+) is as effective at bonding dental fillings as Scotchbondâ„¢ Universal Adhesive (SBU) for preparation of posterior Class I and Class II restorations in adult patients. Participants must have at least two (2) back teeth that need a filling either on the chewing surface alone (Class I) and/or on the chewing surface and between your teeth (Class II). One tooth will be restored using SBU+ and the other tooth will be restored using SBU adhesive, both filled using Filtekâ„¢ Universal Restorative as the filling material.
This is a prospective, randomized, controlled, open-label, assessor-blinded, split-mouth, single-center post-market clinical follow-up study. The study is designed to compare the clinical efficacy of Scotchbondâ„¢ Universal Plus Adhesive with Scotchbondâ„¢ Universal Adhesive when used in self-etch mode for preparation of posterior Class I and Class II restorations using Filtekâ„¢ Universal Restorative material in adult patients.
Selected endpoints are based partly on the FDI World Dental Federation criteria. Subjects who meet all inclusion and none of the exclusion criteria and who have provided informed consent will be eligible for enrollment and must be treated within 21 days of screening. Either two pre-molars or two molars from each Subject will be randomized in a 1:1 ratio such that one of the teeth will be randomized to undergo restoration using SBU+ Adhesive (Treatment), and the other tooth will undergo restoration using SBU Adhesive (Control). Both study teeth will be restored using Filtek™ Universal Restorative material as the filling material. Individual subject participation is expected to last 2 years (± 45 days) with scheduled study visits at screening, day of restoration/baseline, and follow-up visits at 6 months (± 14 days), 1 year (± 30 days), and 2 years (± 45 days) after restoration. 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. All assessments will be performed by two 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, then the examiners will compare their evaluations and a consensus will be reached for each of the scoring criteria at each visit. A consensus will be reached before the Subject leaves the visit, and the consensus assessments will be entered into the Case Report Form (CRF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scotchbond Universal Plus Treatment | Experimental | Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). |
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| Scotchbond Universal Comparator | Active Comparator | Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scotchbondâ„¢ Universal Plus Adhesive | Device | Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbondâ„¢ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative |
| Measure | Description | Time Frame |
|---|---|---|
| Retention of Restorative Material | The percentage of restorations with partial or complete loss of the restoration materials | 24 months post-restoration |
| 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 (Fédération Dentaire Internationale) World Dental Federation criteria. | 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 World Dental Federation criteria. | 24 months post-restoration |
| Measure | Description | Time Frame |
|---|---|---|
| Retention of Restorative Material | The percentage of restorations with partial or complete loss of the restoration materials | 6 months post-restoration |
| Retention of Restorative Material | The percentage of restorations with partial or complete loss of the restoration materials |
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Inclusion Criteria:
Exclusion Criteria:
Intraoperative Exclusion Criteria:
1) The Subject has pulp exposure of either study tooth during the restoration procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Perdigao, DMD, MS, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota School of Dentristry | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20628774 | Background | Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14. | |
| 19492717 |
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Subjects were required to meet all inclusion and none of the exclusion criteria to be eligible for study participation. Any subject with pulp exposure of either study tooth during the restoration procedure was excluded from the study. Two Class I or Class II restorations were placed per patient. Selected study teeth were randomized in a 1:1 ratio with one tooth restored using SBU+ Adhesive (Treatment), and the other tooth restored using SBU Adhesive (Control).
The patient population was selected from current patients under clinical treatment at the University of Minnesota Dental School. 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 direct composite restorations for posterior (premolars or molars) Class I or Class II carious lesions in vital teeth that were asymptomatic and with minimal mobility.
| ID | Title | Description |
|---|---|---|
| FG000 | Scotchbond Universal Plus Treatment | Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Scotchbondâ„¢ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbondâ„¢ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2022 |
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This is a prospective, randomized, controlled, open-label, assessor-blinded, split-mouth, single-center post-market clinical follow-up study.
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All assessments will be performed by two dental examiners that are independent of the dentist that placed the restorations and are blinded to the treatment arms.
| Scotchbondâ„¢ Universal Adhesive | Device | Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbondâ„¢ Universal Adhesive using self-etch mode and Filtek Universal Restorative |
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| 12 months post-restoration |
| 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. | 6 months post-restoration |
| 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. | 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. | baseline day of 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. | 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. | 12 months post-restoration |
| Perdigao J, Dutra-Correa M, Anauate-Netto C, Castilhos N, Carmo AR, Lewgoy HR, Amore R, Cordeiro HJ. Two-year clinical evaluation of self-etching adhesives in posterior restorations. J Adhes Dent. 2009 Apr;11(2):149-59. |
| FG001 | Scotchbond Universal Comparator | Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Scotchbondâ„¢ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbondâ„¢ Universal Adhesive using self-etch mode and Filtek Universal Restorative |
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| COMPLETED | A total of 38 subjects completed the study. One subject had one tooth withdrawn due to non-compliance with study restrictions, for a total of 37 restorations with SBU+ and 38 restorations with SBU completing the study. |
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| NOT COMPLETED |
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51 subjects each had 2 teeth treated in a 1:1 randomization with 1 tooth in each treatment group for a total of 102 restorations.
| ID | Title | Description |
|---|---|---|
| BG000 | Scotchbond Universal Plus Treatment | Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Scotchbondâ„¢ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbondâ„¢ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative |
| BG001 | Scotchbond Universal Comparator | Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Scotchbondâ„¢ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbondâ„¢ Universal Adhesive using self-etch mode and Filtek Universal Restorative |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Restorations |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
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| Age, Customized | Number | Participants | Participants |
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| Sex/Gender, Customized | Number | Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| Tooth Characteristic: Restoration Class | 51 subjects each had 2 teeth treated in a 1:1 randomization with 1 tooth in each treatment group for a total of 102 restorations (55 Class I restorations and 47 Class II restorations). | Count of Units | Restorations | Restorations |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention of Restorative Material | The percentage of restorations with partial or complete loss of the restoration materials | 38 subjects completed the study; 1 subject in the treatment group had 1 tooth withdrawn prior to 24 months | Posted | Number | percentage of restorations | 24 months post-restoration | Restorations | Restorations |
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| Primary | 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 (Fédération Dentaire Internationale) World Dental Federation criteria. | 38 subjects completed the study; 1 subject had 1 tooth withdrawn prior to 24 months Scoring categories for the fracture of restorative material are defined as follows:
| Posted | Number | percentage of restorations | 24 months post-restoration | Restorations | Restorations |
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| Primary | 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 are defined as follows:
| Posted | Number | percentage of restorations | 24 months post-restoration | Restorations | Restorations |
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| Secondary | Retention of Restorative Material | The percentage of restorations with partial or complete loss of the restoration materials | Ten (10) of 51 subjects missed the 6-month follow-up visit. | Posted | Number | percentage of restorations | 6 months post-restoration | Restorations | Restorations |
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| Secondary | Retention of Restorative Material | The percentage of restorations with partial or complete loss of the restoration materials | Six (6) of 51 subjects missed the 1-year follow-up visit. One (1) subject completed the 1-year follow-up visit, but outside the allowed time window and was excluded from this analysis. | Posted | Number | percentage of restorations | 12 months post-restoration | Restorations | Restorations |
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| Secondary | 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. | Ten (10) of 51 subjects missed the 6-month follow-up visit. Scoring categories for the fracture of restorative material are defined as follows:
| Posted | Number | percentage of restorations | 6 months post-restoration | Restorations | Restorations |
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| Secondary | 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. | Six of 51 subjects missed 1-year visit; 1 completed this visit but outside allowed window and was excluded from analysis. Scoring categories for this endpoint are:
| Posted | Number | percentage of restorations | 12 months post-restoration | Restorations | Restorations |
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| Secondary | 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 are defined as follows:
| Posted | Number | percentage of restorations | baseline day of restoration | Restorations | Restorations |
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| Secondary | 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. | 10 of 51 subjects missed 6-month visit. Scoring categories for this result are:
| Posted | Number | percentage of restorations | 6 months post-restoration | Restorations | Restorations |
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| Secondary | 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. | 44/51 subjects returned for this visit. Scoring categories for this result are:
| Posted | Number | percentage of restorations | 12 months post-restoration | Restorations | Restorations |
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All device-related and serious adverse events were collected from the time of restoration through the 24-month follow-up visit. Non-serious, non-device related adverse events were collected from the time of restoration through the 6-month follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Scotchbond Universal Plus Treatment | Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Scotchbondâ„¢ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbondâ„¢ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative | 0 | 51 | 0 | 51 | 8 | 51 |
| EG001 | Scotchbond Universal Comparator | Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Scotchbondâ„¢ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbondâ„¢ Universal Adhesive using self-etch mode and Filtek Universal Restorative | 0 | 51 | 0 | 51 | 8 | 51 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental Restoration Failure | General disorders | MedDRA v24.1 | Systematic Assessment | Complications associated with device not elsewhere classified (NEC). Non-device related adverse event involving a dental restoration or temporary crown on a non-study tooth. NOTE: This event is listed in both groups for a total of 2 events. |
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| Hyperaesthesia teeth | Gastrointestinal disorders | MedDRA v24.1 | Systematic Assessment | Dental pain and sensation disorders. Non-device related sensitivity of teeth. NOTE: Subjects have two teeth treated with 1 tooth per treatment group. This event is listed in both groups for a total of 2 non-device related events. |
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| Dental caries | Gastrointestinal disorders | MedDRA v24.1 | Systematic Assessment | Dental and gingival conditions. Dental cavity non-device related. NOTE: Subjects have two teeth treated with 1 tooth per treatment group. This event is listed in both groups but there was 1 non-device related event total. |
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| Gingival Pain | Gastrointestinal disorders | MedDRA v24.1 | Systematic Assessment | Dental and gingival conditions. Gum pain non-device related. NOTE: Subjects have two teeth treated with 1 tooth per treatment group. This event is listed in both groups but there was 1 non-device related event total. |
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| Periodontal Inflammation | Gastrointestinal disorders | MedDRA v24.1 | Systematic Assessment | Dental and gingival conditions. Periodontal inflammation non-device related. NOTE: Subjects have two teeth treated with 1 tooth per treatment group. This event is listed in both groups but there was 1 non-device related event total. |
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| Tooth Fracture | Gastrointestinal disorders | MedDRA v24.1 | Systematic Assessment | Dental disorder not elsewhere categorized (NEC) non-device related. NOTE: Subjects have two teeth treated with 1 tooth per treatment group. This event is listed in both groups but there was 1 non-device related event total. |
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| Tooth Infection | Infections and infestations | MedDRA v24.1 | Systematic Assessment | Dental and Oral soft tissue infections. Non-device related. NOTE: Subjects have two teeth treated with 1 tooth per treatment group. This event is listed in both groups but there was 1 non-device related event total. |
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| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA v24.1 | Systematic Assessment | Muscle, tendon and ligament injuries. Ankle sprain non-device related. NOTE: Subjects have two teeth treated with 1 tooth per treatment group. This event is listed in both groups but there was 1 non-device related event total. |
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Planned randomization of treating pairs of 2 molars or 2 premolars was not always followed. There were 16 subjects who had pairs of 1 molar and 1 premolar treated. These changes were not expected to impact the results of the study and no adjustments to the analysis plan were made.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paula Myhre | Solventum US LLC | 6513948069 | pemyhre1@solventum.com |
| Oct 22, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| 19 years to 64 years |
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| >= 65 years |
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| Male |
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| Race: Asian |
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| Race: Black or African American |
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| Race: Native Hawaiian or Other Pacific Islander |
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| Race: White |
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| Race: Other |
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| Race: Multiple Race |
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| Ethnicity: Hispanic or Latino |
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| Ethnicity: Not Hispanic or Latino |
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| Ethnicity: Unknown or Not Reported |
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| Class II Restorations |
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