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Status:

COMPLETED

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

Lead Sponsor:

Solventum US LLC

Conditions:

Cavities of Teeth

Dental Decay

Eligibility:

All Genders

18-70 years

Phase:

NA

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 r...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 14 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 6 2025

Estimated Enrollment :

51 Patients enrolled

Trial Details

Trial ID

NCT05248204

Start Date

June 14 2022

End Date

March 6 2025

Last Update

December 17 2025

Active Locations (1)

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1

University of Minnesota School of Dentristry

Minneapolis, Minnesota, United States, 55455