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Adhesive

Dental Adhesives for Tooth Wear (SBU+ClassV Trial)

N/A

Waitlist Available

Led By John Burgess, DDS, MS

Research Sponsored by 3M

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is at least 18 years of age at the time of consent

Subject has a minimum of two teeth with non-carious Class V lesions that are at least 1.5 mm deep, not devitalized, and have not undergone root canal treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months, 12 months, 24 months

Awards & highlights

SBU+ClassV Trial Summary

This trial will compare two dental adhesives to see which works better with Filtek restorative material on Class-V non-carious cervical lesions.

Who is the study for?

This trial is for adults with at least two teeth that have non-carious Class V lesions, which are not dead and haven't had root canal treatment. Participants need good oral hygiene (low plaque levels) and must be healthy enough for dental care as per ASA guidelines. People with allergies to acrylates, salivary gland issues, severe tooth decay or gum disease, or those who can't sit through the dental procedure aren't eligible.Check my eligibility

What is being tested?

The study tests two adhesives: Scotchbond Universal Plus and Scotchbond Universal when used with Filtek restorative material on teeth wear lesions. It's a controlled study where each participant receives both treatments in a random order on different teeth.See study design

What are the potential side effects?

Potential side effects may include sensitivity reactions to the adhesive components like burning or tingling sensations in the treated area, discomfort during application, or allergic responses if one has an existing acrylate allergy.

SBU+ClassV Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have at least two teeth with deep cavities near the gum line that haven't had root canal treatment.

SBU+ClassV Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months, 12 months, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months, 12 months, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 12 months, 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Fracture of Restorative Material

Marginal Adaptation

Restoration Retention

+1 more

Other outcome measures

Baseline post-operative hypersensitivity (subject self-assessment)

Color match

Incidence of adverse events

+6 more

SBU+ClassV Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SBU+ Treatment GroupExperimental Treatment1 Intervention

Either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs will undergo restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive .

Group II: SBU Control GroupActive Control1 Intervention

Either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs will undergo restoration(s) using the predicate device, Scotchbond Universal (SBU) Adhesive.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

3MLead Sponsor

157 Previous Clinical Trials

31,306 Total Patients Enrolled

1 Trials studying Tooth Wear

39 Patients Enrolled for Tooth Wear

John Burgess, DDS, MSPrincipal InvestigatorLouisiana State University HSC Health, School of Dentistry

Media Library

Scotchbond Universal Adhesive (Adhesive) Clinical Trial Eligibility Overview. Trial Name: NCT05361746 — N/A

Tooth Wear Research Study Groups: SBU+ Treatment Group, SBU Control Group

Tooth Wear Clinical Trial 2023: Scotchbond Universal Adhesive Highlights & Side Effects. Trial Name: NCT05361746 — N/A

Scotchbond Universal Adhesive (Adhesive) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05361746 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this clinical trial still available?

"Clinicaltrials.gov indicates that sign-ups for this study have been suspended - it was initially posted on August 18th 2021 and its last update occurred on September 20th 2022. However, there is another trial actively recruiting at present."

Answered by AI

Recent research and studies

Clinical Oral InvestigationsJournal

FDI World Dental Federation: Clinical Criteria for the Evaluation of Direct and Indirect Restorations—update and Clinical Examples

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.

Operative DentistryJournal

Clinical Evaluation of Self-etch and Total-etch Adhesive Systems in Noncarious Cervical Lesions: A Two-year Report

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.

Journal of DentistryJournal

Two-year Clinical Trial of a Universal Adhesive in Total-etch and Self-etch Mode in Non-carious Cervical Lesions

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.

clinicaltrials.govStudy