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Dental Adhesive
Dental Adhesives for Cavities
N/A
Waitlist Available
Led By Jorge Perdigao, DMD, MS, PhD
Research Sponsored by 3M
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 12 months, and 24 months
Awards & highlights
Study Summary
This trial is testing a new dental adhesive to see if it's as effective as the current one at bonding dental fillings.
Who is the study for?
Adults aged 18-70 needing two fillings in back teeth (Class I or II) can join this study. Teeth must be healthy, have minimal movement, and not sensitive. Participants need recent x-rays and must be able to sign consent in English without help. Pregnant women, those with severe gum disease, fewer than 20 teeth, or a history of reactions to dental materials cannot participate.Check my eligibility
What is being tested?
The trial is testing if Scotchbond Universal Plus Adhesive is as good for bonding fillings as the standard Scotchbond Universal Adhesive in adult patients' back teeth. Each participant will get one filling with each adhesive type using Filtek Universal Restorative material.See study design
What are the potential side effects?
While specific side effects are not listed for dental adhesives like Scotchbond products, potential risks may include allergic reactions or sensitivity around the treated area.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
Select...
I need at least two fillings for cavities in back teeth that don't hurt and barely move.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, 12 months, and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 12 months, and 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Approximal Anatomical Form
Color match
Fracture of Restorative Material
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Scotchbond Universal Plus TreatmentExperimental Treatment1 Intervention
Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).
Group II: Scotchbond Universal ComparatorActive Control1 Intervention
Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).
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Who is running the clinical trial?
3MLead Sponsor
157 Previous Clinical Trials
31,424 Total Patients Enrolled
Jorge Perdigao, DMD, MS, PhDPrincipal InvestigatorUniversity of Minnesota
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am in good health overall.I can attend all required study visits.I have severe tooth wear from grinding.The tooth needing a filling has a neighboring tooth that allows for proper contact.My selected teeth touch the opposite natural teeth when I bite down.My tooth is cracked or fractured in a way that might affect its future health.My teeth are very loose due to severe gum disease.You have had a bad reaction to any of the materials used in this study before.I have had braces or similar dental treatments in the last 3 months.I am between 18 and 70 years old.I need at least two fillings for cavities in back teeth that don't hurt and barely move.Your teeth need to be a certain size and shape for the study.I have fewer than 20 teeth.My tooth decay is at an advanced stage.My tooth did not expose the pulp during the dental procedure.I have severe dry mouth.You have a tooth that is sensitive for a long time or has a history of being sensitive.You are currently using or planning to use other materials for dental restoration during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Scotchbond Universal Plus Treatment
- Group 2: Scotchbond Universal Comparator
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this research endeavor for volunteers?
"The clinicaltrials.gov database reveals that this particular investigation is not presently seeking participants, as it was last modified on April 27th 2022. Despite this, there are 103 other trials currently enrolling patients."
Answered by AI
Is this experiment enrolling any octogenarians?
"This clinical trial is open to those aged 18-70. For participants that fit outside of this age bracket, there are 55 studies for minors and 31 trials specifically targeting seniors."
Answered by AI
Who is eligible to volunteer for this experiment?
"Inclusion criteria for this trial requires that participants are dentate and possess a chronilogical age between 18 to 70 years old. A maximum of 50 individuals can be admitted into the clinical study."
Answered by AI
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