Your session is about to expire
← Back to Search
Composite Filling Material
Dental Composite and Adhesive System for Tooth Decay
N/A
Waitlist Available
Led By Erica Teixeira, DDS, MS, PhD
Research Sponsored by Erica Teixeira
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 year, 3 years
Awards & highlights
Study Summary
This trial is comparing a new type of filling to an existing one. Two different fillings will be placed in each person, and researchers will compare how well they work.
Eligible Conditions
- Cavities
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 year, 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 year, 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient satisfaction of the restoration appearance (esthetics) VAS
Secondary outcome measures
Patient satisfaction of the restoration appearance (esthetics) VRS
Percent success of the restoration according to biological aspects
Percent success of the restoration according to functional aspects
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: System AExperimental Treatment19 Interventions
Tokuyama Universal Bond (TUB) single component self-etching 1-step adhesive system w/Tokyuama supra-nanofilled dental composite (ECM) (Tokuyama Dental Corp., Japan), informed consent signed, release of medical information signed, oral exam, health Questionnaire completed and/or updated, xray obtained if needed, pulp vitality testing, Tooth shade determination, photos of teeth, local and/or topical anesthetic applied as necessary, rubber dam isolation, tooth surface cleaned, cavity preparation performed as usual for caries removal, Enamel margins beveled, infinite invisible margins created, adhesive systems applied, dental composite placed, shade selection using Easy Shade 5. Light curing, restoration will be contoured and polished. teeth assessment, clinical assessment
Group II: System BActive Control19 Interventions
ScotchBond Universal one-step adhesive system with Filtek Supreme Ultra™, nanofilled dental composite (3M) will randomly be applied to the other tooth informed consent signed, release of medical information signed, oral exam, health Questionnaire completed and/or updated, xray obtained if needed, pulp vitality testing, Tooth shade determination, photos of teeth, local and/or topical anesthetic applied as necessary, rubber dam isolation, tooth surface cleaned, cavity preparation performed as usual for caries removal, Enamel margins beveled, infinite invisible margins created, adhesive systems applied, dental composite placed, shade selection using Easy Shade 5. Light curing, restoration will be contoured and polished. teeth assessment and clinical assessment at periodic timepoints.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Light Curing
2019
N/A
~50
Contoured and polished
2019
N/A
~50
local and/or topical anesthetic
2019
N/A
~50
enamel margins
2019
N/A
~50
Tokuyama Universal Bond
2019
N/A
~50
cavity preparation
2019
N/A
~50
rubber dam
2019
N/A
~50
Adhesive Systems
2019
N/A
~50
xray
2019
N/A
~50
Pulp vitality testing
2019
N/A
~50
Find a Location
Who is running the clinical trial?
Tokuyama Dental CorporationUNKNOWN
Erica TeixeiraLead Sponsor
Erica Teixeira, DDS, MS, PhDPrincipal Investigator - University of Iowa College of Dentistry
University of Iowa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have less than 20 teeth.You have an allergy to materials or ingredients that contain methacrylate.The teeth that need to be fixed have already had root canal treatment or pulp capping.You have severe and uncontrolled tooth decay.You have bad teeth or gums due to not taking care of your mouth.You have teeth that can be used to support a dental prosthetic.You have severe untreated gum disease or have had recent gum surgery.You have a broken or visibly cracked tooth.You have visible signs of teeth grinding or clenching, such as worn down teeth.You are currently pregnant.You have sensitive teeth or are currently using treatments, pastes, or medications to reduce tooth sensitivity.You need two identical dental restorations in the front teeth area.You are currently receiving or require therapy for your temporomandibular joint (TMJ).You have a history of missing dental appointments.You have dental problems that are causing pain or extensive decay.
Research Study Groups:
This trial has the following groups:- Group 1: System B
- Group 2: System A
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 open vacancies for participants in this trial?
"Per the information hosted on clinicaltrials.gov, this investigation is no longer seeking patients; it was initially posted in January 2019 and last updated July 2022. Although this trial has concluded participant recruitment, 104 other research studies are now recruiting individuals."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger