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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, 5 years
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for adults over 18 with tooth decay needing fillings in the front teeth (#4-#13). They must have a recent x-ray and responsive teeth to cold or electric tests. Excluded are those with allergies to dental materials, fewer than 20 teeth, poor oral hygiene, advanced gum disease, cracked teeth, under research team supervision, pregnant women, bruxism sufferers or those unable to attend follow-ups for 3 years.
What is being tested?
The study compares two types of dental filling composites: System A and System B. Each participant receives one filling from each system in different front teeth. The placement will be done by the same three researchers following a random order determined at the start.
What are the potential side effects?
Potential side effects may include discomfort during treatment like sensitivity to anesthetics used; there might also be reactions related to methacrylate-based materials such as irritation or allergic responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 year, 3 years, 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 year, 3 years, 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patient satisfaction of the restoration appearance (esthetics) VAS
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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.
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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.