Scotchbond Universal Plus Adhesive for Class V Non-carious Cervical Dental Lesions
Phase-Based Progress Estimates
Effectiveness
Safety
Louisiana State University HSC-Health, School of Dentistry, New Orleans, LA
Class V Non-carious Cervical Dental Lesions
Scotchbond Universal Plus Adhesive - DeviceEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary
This trial will compare two dental adhesives to see which works better with Filtek restorative material on Class-V non-carious cervical lesions. The Scotchbond Universal Plus Adhesive is used to treat Class V Non-carious Cervical Dental Lesions and has been previously approved by the FDA for a different condition. The treatment can be done online without the use of a placebo.
Treatment Effectiveness
Effectiveness Progress
Other trials for Class V Non-carious Cervical Dental Lesions
Study Objectives
0 Primary · 4 Secondary · Reporting Duration: 6 months, 12 months, 24 months
24 months
Incidence of adverse events
Time to restoration failure
Month 24
Post-operative hypersensitivity and tooth vitality
7 days
Baseline post-operative hypersensitivity (subject self-assessment)
Month 12
Marginal Adaptation
Restoration Retention
Month 24
Color match
Fracture of Restorative Material
Marginal staining
Patient satisfaction
Polish retention
Secondary Caries
Surface staining
Trial Safety
Safety Progress
Other trials for Class V Non-carious Cervical Dental Lesions
Trial Design
2 Treatment Groups
SBU Control Group
1 of 2
SBU+ Treatment Group
1 of 2
Active Control
Experimental Treatment
46 Total Participants · 2 Treatment Groups
Primary Treatment: Scotchbond Universal Plus Adhesive · No Placebo Group · N/A
SBU+ Treatment Group
Device
Experimental Group · 1 Intervention: Scotchbond Universal Plus Adhesive · Intervention Types: DeviceSBU Control Group
Device
ActiveComparator Group · 1 Intervention: Scotchbond Universal Adhesive · Intervention Types: DeviceTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months, 12 months, 24 months
Closest Location: Louisiana State University HSC-Health, School of Dentistry · New Orleans, LA
N/AFirst Recorded Clinical Trial
1 TrialsResearching Class V Non-carious Cervical Dental Lesions
0 CompletedClinical Trials
Who is running the clinical trial?
3MLead Sponsor
143 Previous Clinical Trials
30,971 Total Patients Enrolled
John Burgess, DDS, MSPrincipal InvestigatorLouisiana State University HSC Health, School of Dentistry
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:A person who is not devitalized is able to give informed consent.
You are at least 18 years of age at the time of consent.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Hickel, Reinhard, Arnd Peschke, Martin Tyas, Ivar Mjör, Stephen Bayne, Mathilde Peters, Karl-Anton Hiller, Ross Randall, Guido Vanherle, and Siegward D. Heintze. 2010. “FDI World Dental Federation: Clinical Criteria for the Evaluation of Direct and Indirect Restorations—update and Clinical Examples”. Clinical Oral Investigations. Springer Science and Business Media LLC. doi:10.1007/s00784-010-0432-8.
- Burgess, JO, R Sadid-Zadeh, D Cakir, and LC Ramp. 2013. “Clinical Evaluation of Self-etch and Total-etch Adhesive Systems in Noncarious Cervical Lesions: A Two-year Report”. Operative Dentistry. Operative Dentistry. doi:10.2341/12-355-cr.
- Lawson, Nathaniel C., Augusto Robles, Chin-Chuan Fu, Chee Paul Lin, Kanchan Sawlani, and John O. Burgess. 2015. “Two-year Clinical Trial of a Universal Adhesive in Total-etch and Self-etch Mode in Non-carious Cervical Lesions”. Journal of Dentistry. Elsevier BV. doi:10.1016/j.jdent.2015.07.009.
- 2022. "Scotchbond Universal Plus Compared to Scotchbond Universal With Filtek Universal Restorative to Restore Class V NCCLs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05361746.
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