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Dental Material
CAD-CAM Dental Crowns for Restorative Dentistry
N/A
Waitlist Available
Led By Dennis J. Fasbinder, DDS
Research Sponsored by Ivoclar Vivadent AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Each lesion or defective restoration should exhibit sufficient size or loss of tooth structure requiring a full crown restoration
All teeth will test vital and be asymptomatic at the beginning of treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 5 years
Awards & highlights
Study Summary
This trial found that using a self-adhesive luting material in combination with total etch/universal bonding agent to place CAD-CAM crowns made of lithium disilicate results in fewer gaps and less excess cement.
Who is the study for?
This trial is for adults over 18 with a cavity or damaged tooth needing a full crown on certain teeth. They must have healthy, symptom-free teeth with at least one opposing and adjacent tooth in good condition. Pregnant women, those allergic to study materials, or unable to attend follow-ups are excluded.Check my eligibility
What is being tested?
The study tests lithium disilicate crowns placed using two different adhesives: dual-curing adhesive or self-adhesive luting material combined with total etch/universal bonding agent. It aims to determine the best method for attaching these types of dental crowns.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include tooth sensitivity, discomfort, or an allergic reaction to the materials used in the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need a full crown due to significant tooth damage or decay.
Select...
All my teeth are healthy and I have no tooth pain.
Select...
I will receive no more than two dental restorations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
short-term post-operative sensitivity
Secondary outcome measures
Quality Criteria (modified FDI criteria)
Side effects data
From 2009 Phase 4 trial • 1270 Patients • NCT0026144315%
AKATHISIA
14%
TREMOR
9%
INSOMNIA
9%
HEADACHE
9%
NAUSEA
8%
SOMNOLENCE
6%
DIZZINESS
6%
DIARRHOEA
6%
SEDATION
5%
EXTRAPYRAMIDAL DISORDER
5%
RESTLESSNESS
4%
WEIGHT INCREASED
2%
PYREXIA
1%
COUGH
1%
PAIN IN EXTREMITY
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single-Blind Aripiprazole
Double-Blind Placebo
Extension Phase Placebo
Double-Blind Aripiprazole
Extension Phase Aripiprazole
Trial Design
2Treatment groups
Experimental Treatment
Group I: Crowns self-adhesively cementedExperimental Treatment1 Intervention
Group 1 receives crowns with an occlusal thickness of 1.5 mm and luted with a self-adhesive, self-curing resin cement (SpeedCem Plus, Ivoclar Vivadent AG).
Group II: Crowns adhesively lutedExperimental Treatment1 Intervention
Group 2 receives crowns with an occlusal thickness of 1.2 mm delivered with a dual-curing resin cement (Variolink Esthetic (DC),Ivoclar Vivadent AG).
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Who is running the clinical trial?
Ivoclar Vivadent AGLead Sponsor
33 Previous Clinical Trials
2,092 Total Patients Enrolled
Dennis J. Fasbinder, DDSPrincipal InvestigatorUniversity of Michigan School of Dentistry, Department of Cariology, Restorative Sciences & Endodontics
2 Previous Clinical Trials
95 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have dead or sensitive teeth.I am 18 years old or older.I have at least one cavity or a need for tooth repair on an upper or lower back tooth.I cannot come back for follow-up visits.I need a full crown due to significant tooth damage or decay.All my teeth are healthy and I have no tooth pain.I have had treatments to protect the nerve inside my tooth.I will receive no more than two dental restorations.I have significant untreated dental issues like gum disease or many cavities.I am not pregnant or breastfeeding.I have a tooth that touches another tooth when I bite and is next to a tooth with a tight space.
Research Study Groups:
This trial has the following groups:- Group 1: Crowns self-adhesively cemented
- Group 2: Crowns adhesively luted
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.
Is there still capacity to join this research trial?
"As per clinicaltrials.gov, this trial is not actively searching for participants at this moment in time. The study was first published on October 1st 2021 and its final update occured on September 27th 2021. Even though the aforementioned investigation has closed enrollment, there are still 21 other trials recruiting patients currently.."
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