N/A N=102 Randomized Single-blind Treatment

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

Cavities of Teeth · Dental Decay

Bottom Line

View on ClinicalTrials.gov: NCT05248204 ↗

Enrolled (actual)

102

Serious AEs

0.0%

Results posted

Dec 2025

Primary outcome: Primary: Retention of Restorative Material — 97; 100; 3; 0 percentage of restorations

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Scotchbond™ Universal Plus Adhesive (Device); Scotchbond™ Universal Adhesive (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Solventum US LLC
Primary completion: Mar 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Retention of Restorative Material	100; 100; 0; 0	—
PRIMARY Fracture of Restorative Material	95.4; 100; 2.3; 0; 2.3; 0	—
PRIMARY Marginal Adaptation	20; 29.55; 80; 65.9; 0; 4.55	—
SECONDARY Retention of Restorative Material	100; 100; 0; 0	—
SECONDARY Retention of Restorative Material	100; 100; 0; 0	—
SECONDARY Fracture of Restorative Material	95.4; 100; 2.3; 0; 2.3; 0	—
SECONDARY Fracture of Restorative Material	95.4; 100; 2.3; 0; 2.3; 0	—
SECONDARY Marginal Adaptation	20; 29.55; 80; 65.9; 0; 4.55	—
SECONDARY Marginal Adaptation	20; 29.55; 80; 65.9; 0; 4.55	—
SECONDARY Marginal Adaptation	20; 29.55; 80; 65.9; 0; 4.55	—

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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).

Intraoperative Exclusion Criteria:

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05248204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.