CompletedNot Applicable

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

United States51 participantsStarted 2022-06-14

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Exclusion criteria

What they're measuring

Retention of Restorative Material

Timeframe: 24 months post-restoration

Fracture of Restorative Material

Timeframe: 24 months post-restoration

Marginal Adaptation

Timeframe: 24 months post-restoration

Trial details

NCT IDNCT05248204

SponsorSolventum US LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-06

Results submitted2025-10-22

View on ClinicalTrials.gov More Cavities of Teeth trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.