Class V Non-carious Cervical Dental LesionsSBU+ClassVNCT05361746
Scotchbond Universal Plus Compared to Scotchbond Universal With Filtek Universal Restorative to Restore Class V NCCLs
A study testing Scotchbond Universal Plus Adhesive and Scotchbond Universal Adhesive in people with Class V Non-carious Cervical Dental Lesions, run by Solventum US LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Class V Non-carious Cervical Dental Lesions
- What is being tested?
- Scotchbond Universal Plus Adhesive and Scotchbond Universal Adhesive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2022to 11 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects may be included that meet the following criteria:
- Subject is at least 18 years of age at the time of consent
- Subject is able to provide their own informed consent
- Subject has a minimum of two teeth that:
- have non-carious Class V lesions that are at least 1.5 mm deep
- are not devitalized
Show all 10Show fewer
- have not undergone root canal treatment
- Subject has an Approximal Plaque Index score ≤ 40% as assessed via explorer and without the use of plaque-disclosing agents
- Subject is able and willing to return for all scheduled study visits
- Subject meets the Level-I or Level-II classification criteria of the American Society of Anesthesiologists (ASA) Physical Status Classification System For Dental Patient Care
Who cannot join
- Subjects may not be included that meet any of the following criteria:
- Subject has any of the following:
- rampant caries
- chronic periodontitis
- salivary gland dysfunction
- Subject is unable, for any reason, to tolerate the procedure time required to place the restorations
Show all 9Show fewer
- Subject has unacceptable oral hygiene (eg, chronic moderate to heavy plaque accumulation along the gumline)
- Subject has known sensitivity to the study product components (ie, acrylate)
- Subject is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University HSC-Health, School of Dentistry
New Orleans, Louisiana, 70119
About this study
Official title: Clinical Performance of a New Dental Adhesive, 3M™ Scotchbond™ Universal Plus Adhesive, Compared to 3M™ Scotchbond™ Universal Adhesive When Used With 3M™ Filtek™ Universal Restorative to Restore Class V Non-carious Cervical Lesions
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.
Read the detailed description
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).
- Being tested
- Scotchbond Universal Plus Adhesive, Scotchbond Universal Adhesive
- Keywords
- composite resins, dental adhesives, noncarious lesions, abfraction lesions, bonding, dental, clinical study, Scotchbond Universal plus, Scotchbond Universal, Filtek, dental materials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scotchbond Universal Plus AdhesiveDevice
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.
Scotchbond Universal AdhesiveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SBU+ Treatment Group | Experimental | In a split-mouth design, either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs underwent restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive . Receives: Device: Scotchbond Universal Plus Adhesive |
| SBU Control Group | Active comparator | In a split-mouth design, either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs underwent restoration(s) using the predicate device, Scotchbond Universal (SBU) Adhesive. Receives: Device: Scotchbond Universal Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of Restorative Material
The percentage of restorations with partial or complete loss of the restorative materials.
Measured: 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:
- Excellent/very good: No clinically detectable gap.
- Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing.
- Sufficient/Satisfactory: Leakage/discoloration is present but limited to the marginal area.
- Unsatisfactory: Localized gap larger than 250 µm, may result in exposure of dentine or base.
- Poor: Generalized gap larger than 250 µm or the restoration is loose but in situ, re-placement necessary.
Measured: 24 months post-restoration
Secondary outcomes (10)
Retention of Restorative Material
The percentage of restorations with partial or complete loss of the restoration material.
Measured: 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:
- Excellent/very good: No clinically detectable gap.
- Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing.
- Sufficient/Satisfactory: Leakage/discoloration is present but limited to the marginal area.
- Unsatisfactory: Localized gap larger than 250 µm, may result in exposure of dentine or base.
- Poor: Generalized gap larger than 250 µm or the restoration is loose but in situ, re-placement necessary.
Measured: 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.
Scoring categories for the fracture of restorative material are defined as follows:
- Excellent/very good: No fractures/cracks
- Good: Small hairline cracks
- Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact
- Unsatisfactory: Material chip fractures which damage marginal quality or approximal contacts
Measured: 6 months post-restoration
Secondary Caries
Secondary caries in study teeth scored on scale 1-5.
- Excellent/Very Good: No secondary or primary caries
- Good: Small and localized areas of demineralization
- Sufficient/Satisfactory: Larger areas of demineralization
- Unsatisfactory: Caries with cavitation and suspected undermining caries
- Poor: Deep caries or exposed dentin not accessible for repair of restoration.
Measured: 6 months post-restoration
Retention of Restorative Material
The percentage of restorations with partial or complete loss of the restoration material.
Measured: 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:
- Excellent/very good: No clinically detectable gap.
- Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing.
- Sufficient/Satisfactory: Leakage/discoloration is present but limited to the marginal area.
- Unsatisfactory: Localized gap larger than 250 µm, may result in exposure of dentine or base.
- Poor: Generalized gap larger than 250 µm or the restoration is loose but in situ, re-placement necessary.
Measured: 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:
- Excellent/very good: No fractures/cracks
- Good: Small hairline cracks
- Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact
- Unsatisfactory: Material chip fractures which damage marginal quality or approximal contacts
Measured: 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.
- Excellent/Very Good: No secondary or primary caries
- Good: Small and localized areas of demineralization
- Sufficient/Satisfactory: Larger areas of demineralization
- Unsatisfactory: Caries with cavitation and suspected undermining caries
- Poor: Deep caries or exposed dentin not accessible for repair of restoration.
Measured: 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:
- Excellent/very good: No fractures/cracks
- Good: Small hairline cracks
- Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact
- Unsatisfactory: Material chip fractures which damage marginal quality or approximal contacts
Measured: 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.
- Excellent/Very Good: No secondary or primary caries
- Good: Small and localized areas of demineralization
- Sufficient/Satisfactory: Larger areas of demineralization
- Unsatisfactory: Caries with cavitation and suspected undermining caries
- Poor: Deep caries or exposed dentin not accessible for repair of restoration.
Measured: 24 months post-restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start18 Aug 2022
- Primary completion7 Apr 2025
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Class V Non-carious Cervical Dental LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each subject had either two restorations (two teeth) or four restorations (four teeth) performed at the beginning of the study, with each tooth restoration using only one type of adhesive. Study teeth were paired according to lesion depth and randomized to treatment in a 1:1 ratio with at least half of the teeth (ie, 1 tooth for Subjects with 2 eligible teeth or 2 teeth for Subjects with 4 eligible teeth) randomized to undergo restoration(s) using Scotchbond Universal Plus Adhesive (SBU+ Treatment group) and the other half of the teeth undergoing restoration(s) using Scotchbond Universal Adhesive (SBU Control group).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alika Yu, DDS, Principal investigator, Louisiana State University HSC Health, School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361746
- Sponsor's protocol ID
- EM-11-050068
- Acronym
- SBU+ClassV
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2022
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 20628774Burgess JO, Sadid-Zadeh R, Cakir D, Ramp LC. Clinical evaluation of self-etch and total-etch adhesive systems in noncarious cervical lesions: a two-year report. Oper Dent. 2013 Sep-Oct;38(5):477-87. doi: 10.2341/12-355-CR. Epub 2013 Jan 17.
PubMed 23327229Lawson NC, Robles A, Fu CC, Lin CP, Sawlani K, Burgess JO. Two-year clinical trial of a universal adhesive in total-etch and self-etch mode in non-carious cervical lesions. J Dent. 2015 Oct;43(10):1229-34. doi: 10.1016/j.jdent.2015.07.009. Epub 2015 Jul 29.
PubMed 26231300
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a New Dental Adhesive, 3M™ Scotchbond™ Universal Plus Adhesive, Compared to 3M™ Scotchbond™ Universal Adhesive When Used With 3M™ Filtek™ Universal Restorative to Restore Class V Non-carious Cervical Lesions
- ClinicalTrials.gov ID
- NCT05361746
- Acronym / sponsor ID
- SBU+ClassV / EM-11-050068
- Keywords
- composite resins, dental adhesives, noncarious lesions, abfraction lesions, bonding, dental, clinical study, Scotchbond Universal plus, Scotchbond Universal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Posted 24 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each subject had either two restorations (two teeth) or four restorations (four teeth) performed at the beginning of the study, with each tooth restoration using only one type of adhesive. Study teeth were paired according to lesion depth and randomized to treatment in a 1:1 ratio with at least half of the teeth (ie, 1 tooth for Subjects with 2 eligible teeth or 2 teeth for Subjects with 4 eligible teeth) randomized to undergo restoration(s) using Scotchbond Universal Plus Adhesive (SBU+ Treatment group) and the other half of the teeth undergoing restoration(s) using Scotchbond Universal Adhesive (SBU Control group).
| Arm | Type | Receives |
|---|---|---|
| SBU+ Treatment Group | Experimental | Device: Scotchbond Universal Plus AdhesiveIn a split-mouth design, either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs underwent restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive . |
| SBU Control Group | Active comparator | Device: Scotchbond Universal AdhesiveIn a split-mouth design, either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs underwent restoration(s) using the predicate device, Scotchbond Universal (SBU) Adhesive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is at least 18 years of age at the time of consent
- Subject is able to provide their own informed consent
- Subject has a minimum of two teeth that:
- Subject has an Approximal Plaque Index score ≤ 40% as assessed via explorer and without the use of plaque-disclosing agents
- Subject is able and willing to return for all scheduled study visits
Key exclusion criteria (9 listed)
- Subject has any of the following:
- Subject is unable, for any reason, to tolerate the procedure time required to place the restorations
- Subject has unacceptable oral hygiene (eg, chronic moderate to heavy plaque accumulation along the gumline)
- Subject has known sensitivity to the study product components (ie, acrylate)
- Subject is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scotchbond Universal Plus AdhesiveEligible 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. | Device | SBU+ Treatment Group |
| Scotchbond Universal AdhesiveEligible 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. | Device | SBU Control Group |
Primary outcome
Retention of Restorative Material
Time frame: 24 months post-restoration
The percentage of restorations with partial or complete loss of the restorative materials.
Marginal Adaptation
Time frame: 24 months post-restoration
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.
10 secondary outcomes
Retention of Restorative Material
Time frame: 6 months post-restoration
Marginal Adaptation
Time frame: 6 months post restoration
Fracture of Restorative Material
Time frame: 6 months post-restoration
Secondary Caries
Time frame: 6 months post-restoration
Retention of Restorative Material
Time frame: 12 months post-restoration
Marginal Adaptation
Time frame: 12 months post-restoration
Fracture of Restorative Material
Time frame: 12 months post-restoration
Secondary Caries
Time frame: 12 months post-restoration
Fracture of Restorative Material
Time frame: 24 months post-restoration
Secondary Caries
Time frame: 24 months post-restoration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20628774Hickel 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.
- Background: PubMed 23327229Burgess JO, Sadid-Zadeh R, Cakir D, Ramp LC. Clinical evaluation of self-etch and total-etch adhesive systems in noncarious cervical lesions: a two-year report. Oper Dent. 2013 Sep-Oct;38(5):477-87. doi: 10.2341/12-355-CR. Epub 2013 Jan 17.
- Background: PubMed 26231300Lawson NC, Robles A, Fu CC, Lin CP, Sawlani K, Burgess JO. Two-year clinical trial of a universal adhesive in total-etch and self-etch mode in non-carious cervical lesions. J Dent. 2015 Oct;43(10):1229-34. doi: 10.1016/j.jdent.2015.07.009. Epub 2015 Jul 29.
- Individual participant dataSharing planned: No
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Class V Dental Caries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alika Yu, DDS principal investigator
Louisiana State University HSC Health, School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scotchbond Universal Plus Adhesive and Scotchbond Universal Adhesive in people with Class V Non-carious Cervical Dental Lesions, run by Solventum US LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention of Restorative Material (time frame: 24 months post-restoration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05361746, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.