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

NCT05248204 | Completed Results FDA Device

• 1 other identifier: EM-11-050069
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cavities of Teeth; Dental Decay

Keywords

dental materials; dental adhesives; dental fillings; dental cavities; Scotchbond Universal Plus; Scotchbond Universal; Filtek Universal Restorative

Outcome Measures

Primary Outcomes (3)

• Retention of Restorative Material

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

  24 months post-restoration

• Fracture of Restorative Material

  Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI (Fédération Dentaire Internationale) World Dental Federation criteria.

  24 months post-restoration

• Marginal Adaptation

  Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.

  24 months post-restoration

Secondary Outcomes (7)

• Retention of Restorative Material

  6 months post-restoration

• Retention of Restorative Material

  12 months post-restoration

• Fracture of Restorative Material

  6 months post-restoration

• Fracture of Restorative Material

  12 months post-restoration

• Marginal Adaptation

  baseline day of restoration

Study Arms (2)

Scotchbond Universal Plus Treatment

EXPERIMENTAL

Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).

Device: Scotchbond™ Universal Plus Adhesive

Scotchbond Universal Comparator

ACTIVE COMPARATOR

Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).

Device: Scotchbond™ Universal Adhesive

Interventions

Scotchbond™ Universal Adhesive DEVICE

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

Scotchbond Universal Comparator

Scotchbond™ Universal Plus Adhesive DEVICE

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 Plus Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The Subject is between the ages of 18 and 70 years old at time of consent.
• 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).
• 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
• 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.
• The Subject is able and willing to sign Informed Consent Form in English without assistance.
• The Subject is able and willing to be available for all scheduled study visits.
• The Subject is in good general health (ie, meets American Society of Anesthesiologists (ASA) Level I or ASA Level II classification criteria).
• The selected teeth need to have occlusal contact with an antagonistic natural tooth.
• The Subject has existing radiographic images of the study teeth of current and acceptable diagnostic quality obtained within the previous 12 months.

You may not qualify if:

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

Sponsors & Collaborators

• Solventum US LLC: lead

Study Sites (1)

University of Minnesota School of Dentristry

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (2)

• 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.

  PMID: 20628774 BACKGROUND

• 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.

  PMID: 19492717 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

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.

Results Point of Contact

• Title: Paula Myhre
• Organization: Solventum US LLC

pemyhre1@solventum.com

6513948069

Study Officials

• Jorge Perdigao, DMD, MS, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, controlled, open-label, assessor-blinded, split-mouth, single-center post-market clinical follow-up study.

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 21, 2022
• Study Start: June 14, 2022
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)