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Completed

NCT Number: NCT05361746

Scotchbond Universal Plus Compared to Scotchbond Universal With Filtek Universal Restorative to Restore Class V NCCLs

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.

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Key information

Conditions

Class V Non-carious Cervical Dental Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louisiana State University HSC-Health, School of Dentistry

New Orleans, Louisiana, 70119, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • 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

Exclusion criteria

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
  • 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

Treatment and study plan

Scotchbond Universal Plus Adhesive

Device

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 Adhesive

Device

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.

Primary outcomes

  1. Retention of Restorative Material

    Time frame: 24 months post-restoration

    The percentage of restorations with partial or complete loss of the restorative materials.

  2. 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:

    • 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.

Secondary outcomes

  1. Retention of Restorative Material

    Time frame: 6 months post-restoration

    The percentage of restorations with partial or complete loss of the restoration material.

  2. Marginal Adaptation

    Time frame: 6 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 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.

  3. Fracture of Restorative Material

    Time frame: 6 months post-restoration

    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

  4. Secondary Caries

    Time frame: 6 months post-restoration

    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.

  5. Retention of Restorative Material

    Time frame: 12 months post-restoration

    The percentage of restorations with partial or complete loss of the restoration material.

  6. Marginal Adaptation

    Time frame: 12 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 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.

  7. Fracture of Restorative Material

    Time frame: 12 months post-restoration

    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

  8. Secondary Caries

    Time frame: 12 months post-restoration

    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.

  9. Fracture of Restorative Material

    Time frame: 24 months post-restoration

    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

  10. Secondary Caries

    Time frame: 24 months post-restoration

    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.

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Registry information

Official study 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

Acronym: SBU+ClassV

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 5, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.