Status:
ACTIVE_NOT_RECRUITING
Scotchbond Universal Plus Compared to Scotchbond Universal With Filtek Universal Restorative to Restore Class V NCCLs
Lead Sponsor:
Solventum US LLC
Conditions:
Class V Non-carious Cervical Dental Lesions
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, controlled, within-subject, randomized, single-center study comparing Scotchbond Universal Plus and Scotchbond Universal adhesives when used with Filtek restorative. The study w...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05361746
Start Date
August 18 2022
End Date
July 30 2025
Last Update
September 26 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Louisiana State University HSC-Health, School of Dentistry
New Orleans, Louisiana, United States, 70119