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CompletedNCT05248204Updated Dec 17, 2025Results posted

Scotchbond Universal Plus Compared to Scotchbond Universal for Posterior Class I & II Restorations With Filtek Universal

An interventional study of Scotchbond™ Universal Plus Adhesive and Scotchbond™ Universal Adhesive in Cavities of Teeth and Dental Decay, sponsored by Solventum US LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-17.

Sponsored by Solventum US LLC · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This research study is looking at a new bond-promoting substance (a dental adhesive called 3M™ Scotchbond™ Universal Plus Adhesive) used between the tooth and dental restoration (filling). This is a randomized, split-mouth study designed to evaluate whether Scotchbond™ Universal Plus Adhesive (SBU+) is as effective at bonding dental fillings as Scotchbond™ 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 Filtek™ Universal Restorative as the filling material.

Read the detailed description

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 Scotchbond™ Universal Plus Adhesive with Scotchbond™ Universal Adhesive when used in self-etch mode for preparation of posterior Class I and Class II restorations using Filtek™ 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).

02

Conditions studied

  • Cavities of Teeth
  • Dental Decay

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Keywords

  • dental materials
  • dental adhesives
  • dental fillings
  • dental cavities
  • Scotchbond Universal Plus
  • Scotchbond Universal
  • Filtek Universal Restorative
03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 51 is below the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Solventum US LLC is the lead sponsor of 62 studies on the registry; 2 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The Subject is between the ages of 18 and 70 years old at time of consent.
  2. The Subject requires at least two direct composite restorations for posterior Class I or Class II carious lesions in vital teeth that are asymptomatic and with minimal mobility (\< 1 mm in the buccolingual direction).
  3. Study teeth have a minimum buccolingual diameter of the occlusal surface that is at least 1/3 of the distance between the buccal and lingual cusps
  4. Teeth selected for Class II restorations need to have an adjacent tooth in a position that will allow for a contact relationship to be established.
  5. The Subject is able and willing to sign Informed Consent Form in English without assistance.
  6. The Subject is able and willing to be available for all scheduled study visits.
  7. The Subject is in good general health (ie, meets American Society of Anesthesiologists (ASA) Level I or ASA Level II classification criteria).
  8. The selected teeth need to have occlusal contact with an antagonistic natural tooth.
  9. The Subject has existing radiographic images of the study teeth of current and acceptable diagnostic quality obtained within the previous 12 months.

Exclusion criteria

Exclusion Criteria:

  1. The Subject has a history of adverse reaction to any materials used in this study.
  2. The Subject is pregnant or breast feeding at the time of screening.
  3. The Subject has fewer than 20 teeth.
  4. The Subject is taking part in or planned to be enrolled in an evaluation of other restorative materials at any time during the study.
  5. The Subject has advanced periodontal disease (ie, Grace \& Smales Mobility Index grade ≥ 2) that involve the study teeth.
  6. The Subject had orthodontic appliance treatment within the previous 3 months.
  7. The Subject has pronounced enamel wear facets, indicating severe, on-going bruxism.
  8. The Subject has severe xerostomia.
  9. The study tooth has a history of or existing, prolonged tooth hypersensitivity.
  10. The study tooth is an abutment for fixed or removable prostheses.
  11. The study tooth has a fracture or is visibly cracked such that it may impact the longevity of the tooth.
  12. The carious lesion is stage RC5 or RC6 of the ICDAS radiographic scoring system.
  13. The Subject is unable to understand study procedures or provide consent in English.
  14. The Subject is an employee or student of the study investigator(s).

Intraoperative Exclusion Criteria:

1) The Subject has pulp exposure of either study tooth during the restoration procedure.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    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).

    Device: Scotchbond™ Universal Plus Adhesive

  • Active comparator
    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).

    Device: Scotchbond™ Universal Adhesive

Interventions

  • DeviceScotchbond™ 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

  • DeviceScotchbond™ 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

06

What researchers measure

Primary outcomes

  1. Retention of Restorative Material

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

    Time frame: 24 months post-restoration

  2. 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.

    Time frame: 24 months post-restoration

  3. 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.

    Time frame: 24 months post-restoration

Secondary outcomes

  1. Retention of Restorative Material

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

    Time frame: 6 months post-restoration

  2. Retention of Restorative Material

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

    Time frame: 12 months post-restoration

  3. 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.

    Time frame: 6 months post-restoration

  4. 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.

    Time frame: 12 months post-restoration

  5. 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.

    Time frame: baseline day of restoration

  6. 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.

    Time frame: 6 months post-restoration

  7. 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.

    Time frame: 12 months post-restoration

07

Results

Posted Dec 17, 2025
Limitations and caveats
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.

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.

Participant flow — Overall Study
MilestoneScotchbond Universal Plus TreatmentScotchbond Universal Comparator
Started5151
Completed3738
Not completed1413
Withdrew: Lost to follow-up1313
Withdrew: Protocol violation10

Outcome measures

PrimaryRetention of Restorative Material

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

Time frame:
24 months post-restoration
Reported as:
Number · percentage of restorations
Retention of Restorative Material
percentage of restorationsScotchbond Universal Plus TreatmentScotchbond Universal Comparator
No loss of restorative material97100
Partial or complete loss of restorative material30
PrimaryFracture 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.

Time frame:
24 months post-restoration
Reported as:
Number · percentage of restorations
Fracture of Restorative Material
percentage of restorationsScotchbond Universal Plus TreatmentScotchbond Universal Comparator
1. Excellent/Very Good97100
2. Good00
3. Sufficient/Satisfactory30
4. Unsatisfactory00
PrimaryMarginal 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.

Time frame:
24 months post-restoration
Reported as:
Number · percentage of restorations
Marginal Adaptation
percentage of restorationsScotchbond Universal Plus TreatmentScotchbond Universal Comparator
1. Excellent/Very Good84
2. Good9294
3. Sufficient/Satisfactory02
4. Unsatisfactory00
5. Poor00
SecondaryRetention of Restorative Material

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

Time frame:
6 months post-restoration
Reported as:
Number · percentage of restorations
Retention of Restorative Material
percentage of restorationsScotchbond Universal Plus TreatmentScotchbond Universal Comparator
No loss of restorative material100100
Partial or complete loss of restorative material00
SecondaryRetention of Restorative Material

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

Time frame:
12 months post-restoration
Reported as:
Number · percentage of restorations
Retention of Restorative Material
percentage of restorationsScotchbond Universal Plus TreatmentScotchbond Universal Comparator
No loss of restorative material100100
Partial or complete loss of restorative material00
SecondaryFracture 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.

Time frame:
6 months post-restoration
Reported as:
Number · percentage of restorations
Fracture of Restorative Material
percentage of restorationsScotchbond Universal Plus TreatmentScotchbond Universal Comparator
1. Excellent/Very Good9398
2. Good22
3. Sufficient/Satisfactory50
4. Unsatisfactory00
SecondaryFracture 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.

Time frame:
12 months post-restoration
Reported as:
Number · percentage of restorations
Fracture of Restorative Material
percentage of restorationsScotchbond Universal Plus TreatmentScotchbond Universal Comparator
1. Excellent/Very Good95.4100
2. Good2.30
3. Sufficient/Satisfactory2.30
4. Unsatisfactory00
SecondaryMarginal 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.

Time frame:
baseline day of restoration
Reported as:
Number · percentage of restorations
Marginal Adaptation
percentage of restorationsScotchbond Universal Plus TreatmentScotchbond Universal Comparator
1. Excellent/Very Good3337
2. Good6763
3. Sufficient/Satisfactory00
4. Unsatisfactory00
5. Poor00
SecondaryMarginal 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.

Time frame:
6 months post-restoration
Reported as:
Number · percentage of restorations
Marginal Adaptation
percentage of restorationsScotchbond Universal Plus TreatmentScotchbond Universal Comparator
1. Excellent/Very Good2217.1
2. Good7680.5
3. Sufficient/Satisfactory22.4
4. Unsatisfactory00
5. Poor00
SecondaryMarginal 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.

Time frame:
12 months post-restoration
Reported as:
Number · percentage of restorations
Marginal Adaptation
percentage of restorationsScotchbond Universal Plus TreatmentScotchbond Universal Comparator
1. Excellent/Very Good2029.55
2. Good8065.9
3. Sufficient/Satisfactory04.55
4. Unsatisfactory00
5. Poor00

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Scotchbond Universal Plus Treatment0/51 (0%)0/51 (0%)8/51 (15.7%)
Scotchbond Universal Comparator0/51 (0%)0/51 (0%)8/51 (15.7%)
Most frequent other events
Most frequent other events
EventScotchbond Universal Plus TreatmentScotchbond Universal Comparator
Dental Restoration FailureGeneral disorders2/512/51
Hyperaesthesia teethGastrointestinal disorders2/512/51
Dental cariesGastrointestinal disorders1/511/51
Gingival PainGastrointestinal disorders1/511/51
Periodontal InflammationGastrointestinal disorders1/511/51
Tooth FractureGastrointestinal disorders1/511/51
Tooth InfectionInfections and infestations1/511/51
Ligament SprainInjury, poisoning and procedural complications1/511/51

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.

Age, Continuous
Age, Continuous(years)Scotchbond Universal Plus TreatmentScotchbond Universal ComparatorTotal
Mean33 ± 12.433 ± 12.433 ± 12.4
Age, Customized
Age, Customized(Participants)Scotchbond Universal Plus TreatmentScotchbond Universal ComparatorTotal
<=18 years000
19 years to 64 years505050
>= 65 years111
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Scotchbond Universal Plus TreatmentScotchbond Universal ComparatorTotal
Female282828
Male232323
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Scotchbond Universal Plus TreatmentScotchbond Universal ComparatorTotal
Race: American Indian or Alaska Native000
Race: Asian999
Race: Black or African American121212
Race: Native Hawaiian or Other Pacific Islander000
Race: White232323
Race: Other333
Race: Multiple Race444
Ethnicity: Hispanic or Latino555
Ethnicity: Not Hispanic or Latino444444
Ethnicity: Unknown or Not Reported222
Region of Enrollment
Region of Enrollment(participants)Scotchbond Universal Plus TreatmentScotchbond Universal ComparatorTotal
United States515151
Tooth Characteristic: Restoration Class
Tooth Characteristic: Restoration Class(Restorations)Scotchbond Universal Plus TreatmentScotchbond Universal ComparatorTotal
Class I Restorations262955
Class II Restorations252247
08

Study locations

1 site
  • University of Minnesota School of Dentristry
    Minneapolis, Minnesota 55455, United States
09

References and documents

Publications

  • 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. PubMed 20628774 ↗
  • 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. PubMed 19492717 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 27, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05248204
Lead sponsor
Solventum US LLC
Responsible party
Sponsor
First posted
Feb 21, 2022
Start date
Jun 14, 2022
Primary completion
Mar 6, 2025
Completion
Mar 6, 2025
Results posted
Dec 17, 2025
Last update
Dec 17, 2025

Study contacts

Jorge Perdigao, DMD, MS, PhD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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