Trial Outcomes & Findings for Scotchbond Universal Plus Compared to Scotchbond Universal for Posterior Class I & II Restorations With Filtek Universal (NCT NCT05248204)

NCT ID: NCT05248204

Last Updated: 2025-12-17

Results Overview

The percentage of restorations with partial or complete loss of the restoration materials

Recruitment status

COMPLETED

Study phase

Target enrollment

51 participants

Primary outcome timeframe

24 months post-restoration

Results posted on

2025-12-17

Participant Flow

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.

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).

Unit of analysis: Restorations

Participant milestones

Participant milestones
Measure	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). Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative	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). Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative
Overall Study STARTED	51 51	51 51
Overall Study COMPLETED	37 37	38 38
Overall Study NOT COMPLETED	14 14	13 13

Reasons for withdrawal

Reasons for withdrawal
Measure	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). Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative	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). Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative
Overall Study Lost to Follow-up	13	13
Overall Study Protocol Violation	1	0

Baseline Characteristics

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).

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 24 months post-restoration

Population: 38 subjects completed the study; 1 subject in the treatment group had 1 tooth withdrawn prior to 24 months

The percentage of restorations with partial or complete loss of the restoration materials

Outcome measures

Outcome measures
Measure	Scotchbond Universal Plus Treatment n=37 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative	Scotchbond Universal Comparator n=38 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative
Retention of Restorative Material No loss of restorative material	97 percentage of restorations	100 percentage of restorations
Retention of Restorative Material Partial or complete loss of restorative material	3 percentage of restorations	0 percentage of restorations

PRIMARY outcome

Timeframe: 24 months post-restoration

Population: 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: 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

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.

Outcome measures

Outcome measures
Measure	Scotchbond Universal Plus Treatment n=37 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative	Scotchbond Universal Comparator n=38 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative
Fracture of Restorative Material 1. Excellent/Very Good	97 percentage of restorations	100 percentage of restorations
Fracture of Restorative Material 2. Good	0 percentage of restorations	0 percentage of restorations
Fracture of Restorative Material 3. Sufficient/Satisfactory	3 percentage of restorations	0 percentage of restorations
Fracture of Restorative Material 4. Unsatisfactory	0 percentage of restorations	0 percentage of restorations

PRIMARY outcome

Timeframe: 24 months post-restoration

Population: Scoring categories for marginal adaptation are defined as follows: 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 major gap that may result in exposure of dentine or base. 5. Poor: Generalized major gap or irregularities; or the restoration is loose but in situ.

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.

Outcome measures

Outcome measures
Measure	Scotchbond Universal Plus Treatment n=37 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative	Scotchbond Universal Comparator n=38 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative
Marginal Adaptation 4. Unsatisfactory	0 percentage of restorations	0 percentage of restorations
Marginal Adaptation 5. Poor	0 percentage of restorations	0 percentage of restorations
Marginal Adaptation 1. Excellent/Very Good	8 percentage of restorations	4 percentage of restorations
Marginal Adaptation 2. Good	92 percentage of restorations	94 percentage of restorations
Marginal Adaptation 3. Sufficient/Satisfactory	0 percentage of restorations	2 percentage of restorations

SECONDARY outcome

Timeframe: 6 months post-restoration

Population: Ten (10) of 51 subjects missed the 6-month follow-up visit.

The percentage of restorations with partial or complete loss of the restoration materials

Outcome measures

Outcome measures
Measure	Scotchbond Universal Plus Treatment n=41 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative	Scotchbond Universal Comparator n=41 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative
Retention of Restorative Material No loss of restorative material	100 percentage of restorations	100 percentage of restorations
Retention of Restorative Material Partial or complete loss of restorative material	0 percentage of restorations	0 percentage of restorations

SECONDARY outcome

Timeframe: 12 months post-restoration

Population: 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.

The percentage of restorations with partial or complete loss of the restoration materials

Outcome measures

Outcome measures
Measure	Scotchbond Universal Plus Treatment n=44 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative	Scotchbond Universal Comparator n=44 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative
Retention of Restorative Material No loss of restorative material	100 percentage of restorations	100 percentage of restorations
Retention of Restorative Material Partial or complete loss of restorative material	0 percentage of restorations	0 percentage of restorations

SECONDARY outcome

Timeframe: 6 months post-restoration

Population: Ten (10) of 51 subjects missed the 6-month follow-up visit. 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

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.

Outcome measures

Outcome measures
Measure	Scotchbond Universal Plus Treatment n=41 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative	Scotchbond Universal Comparator n=41 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative
Fracture of Restorative Material 1. Excellent/Very Good	93 percentage of restorations	98 percentage of restorations
Fracture of Restorative Material 2. Good	2 percentage of restorations	2 percentage of restorations
Fracture of Restorative Material 3. Sufficient/Satisfactory	5 percentage of restorations	0 percentage of restorations
Fracture of Restorative Material 4. Unsatisfactory	0 percentage of restorations	0 percentage of restorations

SECONDARY outcome

Timeframe: 12 months post-restoration

Population: 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: 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

Outcome measures

Outcome measures
Measure	Scotchbond Universal Plus Treatment n=44 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative	Scotchbond Universal Comparator n=44 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative
Fracture of Restorative Material 1. Excellent/Very Good	95.4 percentage of restorations	100 percentage of restorations
Fracture of Restorative Material 2. Good	2.3 percentage of restorations	0 percentage of restorations
Fracture of Restorative Material 3. Sufficient/Satisfactory	2.3 percentage of restorations	0 percentage of restorations
Fracture of Restorative Material 4. Unsatisfactory	0 percentage of restorations	0 percentage of restorations

SECONDARY outcome

Timeframe: baseline day of restoration

Outcome measures

Outcome measures
Measure	Scotchbond Universal Plus Treatment n=51 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative	Scotchbond Universal Comparator n=51 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative
Marginal Adaptation 1. Excellent/Very Good	33 percentage of restorations	37 percentage of restorations
Marginal Adaptation 2. Good	67 percentage of restorations	63 percentage of restorations
Marginal Adaptation 3. Sufficient/Satisfactory	0 percentage of restorations	0 percentage of restorations
Marginal Adaptation 4. Unsatisfactory	0 percentage of restorations	0 percentage of restorations
Marginal Adaptation 5. Poor	0 percentage of restorations	0 percentage of restorations

SECONDARY outcome

Timeframe: 6 months post-restoration

Population: 10 of 51 subjects missed 6-month visit. Scoring categories for this result are: 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 major gap that may result in exposure of dentine or base 5. Poor: Generalized major gap or irregularities; or restoration is loose but in situ

Outcome measures

Outcome measures
Measure	Scotchbond Universal Plus Treatment n=41 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative	Scotchbond Universal Comparator n=41 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative
Marginal Adaptation 1. Excellent/Very Good	22 percentage of restorations	17.1 percentage of restorations
Marginal Adaptation 2. Good	76 percentage of restorations	80.5 percentage of restorations
Marginal Adaptation 3. Sufficient/Satisfactory	2 percentage of restorations	2.4 percentage of restorations
Marginal Adaptation 4. Unsatisfactory	0 percentage of restorations	0 percentage of restorations
Marginal Adaptation 5. Poor	0 percentage of restorations	0 percentage of restorations

SECONDARY outcome

Timeframe: 12 months post-restoration

Population: 44/51 subjects returned for this visit. Scoring categories for this result are: 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 major gap that may result in exposure of dentine or base 5. Poor: Generalized major gap or irregularities; or restoration is loose but in situ

Outcome measures

Outcome measures
Measure	Scotchbond Universal Plus Treatment n=44 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative	Scotchbond Universal Comparator n=44 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative
Marginal Adaptation 1. Excellent/Very Good	20 percentage of restorations	29.55 percentage of restorations
Marginal Adaptation 2. Good	80 percentage of restorations	65.9 percentage of restorations
Marginal Adaptation 3. Sufficient/Satisfactory	0 percentage of restorations	4.55 percentage of restorations
Marginal Adaptation 4. Unsatisfactory	0 percentage of restorations	0 percentage of restorations
Marginal Adaptation 5. Poor	0 percentage of restorations	0 percentage of restorations

Adverse Events

Scotchbond Universal Plus Treatment

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Scotchbond Universal Comparator

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Scotchbond Universal Plus Treatment n=51 participants at risk Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative	Scotchbond Universal Comparator n=51 participants at risk Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative
General disorders Dental Restoration Failure	3.9% 2/51 • Number of events 2 • 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.	3.9% 2/51 • Number of events 2 • 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.
Gastrointestinal disorders Hyperaesthesia teeth	3.9% 2/51 • Number of events 2 • 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.	3.9% 2/51 • Number of events 2 • 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.
Gastrointestinal disorders Dental caries	2.0% 1/51 • Number of events 1 • 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.	2.0% 1/51 • Number of events 1 • 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.
Gastrointestinal disorders Gingival Pain	2.0% 1/51 • Number of events 1 • 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.	2.0% 1/51 • Number of events 1 • 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.
Gastrointestinal disorders Periodontal Inflammation	2.0% 1/51 • Number of events 1 • 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.	2.0% 1/51 • Number of events 1 • 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.
Gastrointestinal disorders Tooth Fracture	2.0% 1/51 • Number of events 1 • 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.	2.0% 1/51 • Number of events 1 • 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.
Infections and infestations Tooth Infection	2.0% 1/51 • Number of events 1 • 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.	2.0% 1/51 • Number of events 1 • 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.
Injury, poisoning and procedural complications Ligament Sprain	2.0% 1/51 • Number of events 1 • 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.	2.0% 1/51 • Number of events 1 • 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.

Additional Information

Paula Myhre

Solventum US LLC

Phone: 6513948069

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Scotchbond Universal Plus Treatment n=51 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment). Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative	Scotchbond Universal Comparator n=51 Restorations Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control). Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative	Total n=102 Restorations Total of all reporting groups
Sex/Gender, Customized Male	23 Participants n=6 Participants	23 Participants n=5 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Race: American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Age, Continuous	33 years STANDARD_DEVIATION 12.4 • n=6 Participants	33 years STANDARD_DEVIATION 12.4 • n=5 Participants	33 years STANDARD_DEVIATION 12.4 • n=5 Participants
Age, Customized <=18 years	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Age, Customized 19 years to 64 years	50 Participants n=6 Participants	50 Participants n=5 Participants	50 Participants n=5 Participants
Age, Customized >= 65 years	1 Participants n=6 Participants	1 Participants n=5 Participants	1 Participants n=5 Participants
Sex/Gender, Customized Female	28 Participants n=6 Participants	28 Participants n=5 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Race: Asian	9 Participants n=6 Participants	9 Participants n=5 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Race: Black or African American	12 Participants n=6 Participants	12 Participants n=5 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Race: Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race: White	23 Participants n=6 Participants	23 Participants n=5 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Race: Other	3 Participants n=6 Participants	3 Participants n=5 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race: Multiple Race	4 Participants n=6 Participants	4 Participants n=5 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity: Hispanic or Latino	5 Participants n=6 Participants	5 Participants n=5 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity: Not Hispanic or Latino	44 Participants n=6 Participants	44 Participants n=5 Participants	44 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity: Unknown or Not Reported	2 Participants n=6 Participants	2 Participants n=5 Participants	2 Participants n=5 Participants
Region of Enrollment United States	51 participants n=6 Participants	51 participants n=5 Participants	51 participants n=5 Participants
Tooth Characteristic: Restoration Class Class I Restorations	26 Restorations n=68 Restorations • 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).	29 Restorations n=80 Restorations • 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).	55 Restorations n=163 Restorations • 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).
Tooth Characteristic: Restoration Class Class II Restorations	25 Restorations n=68 Restorations • 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).	22 Restorations n=80 Restorations • 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).	47 Restorations n=163 Restorations • 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).