- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02464540
Optical Properties of Light Cured Luting Agent on Laminate Veneer
Randomized Clinical Trial of Light Cured Luting Agents on Laminate Veneers
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
RS
-
Pelotas, RS, Brazil, 96015-560
- Noéli Boscato
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Minimum 18 years of age
- Patients with diastema
- Conoid teeth
- Misaligned anterior teeth
- Discolored teeth and/or teeth with erosion/abrasion
- Posterior occlusal stability
- Individuals who are willing to attend the clinics on predetermined days, to agree to sign the consent form and clarified, after receiving information about the study objectives, risks and benefits associated with the procedures.
Exclusion Criteria:
- Patients with extensive loss of tooth structure
- Subjects suffering from temporomandibular disorders, neurological and oral mucosa diseases
- Inadequate oral hygiene or periodontal problems
- Smokers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Light-cured resin cement
Laminate veneers luted using light-cured resin cement
|
After the use of light-cured luting agent the color of laminate venners will be performed with visual evaluation based on Vita and 3D Master scales and with a spectrophotometer Vita Easyshade (Vita Zahnfabrik / Bad Saeckingen, Germany) based on CIEL*a* b system.
Data collected will be evaluated for translucency parameter (TP) and color variation (ΔE) according to luting agent, thickness and color of the LVs as well as color of dental substrate.
Additionally, the color obtained with visual evaluation and with spectrophotometer will be compared to evaluate the level of agreement between the color observed by the operator and the color named by the spectrophotometer.
|
Active Comparator: Light-cured flowable composite
Laminate veneers luted using light-cured flowable composite
|
After the use of light-cured luting agent the color of laminate veneers will be performed with visual evaluation based on Vita and 3D Master scales and with a spectrophotometer Vita Easyshade (Vita Zahnfabrik / Bad Saeckingen, Germany) based on CIEL*a* b system.
Data collected will be evaluated for translucency parameter (TP) and color variation (ΔE) according to luting agent, thickness and color of the LVs as well as color of dental substrate.
Additionally, the color obtained with visual evaluation and with spectrophotometer will be compared to evaluate the level of agreement between the color observed by the operator and the color named by the spectrophotometer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optical Properties of Laminate Veneers
Time Frame: after luting the laminate veneers (at least 1 hours after cementation)
|
The color of laminate veneers will be performed with a spectrophotometer Vita Easyshade (Vita Zahnfabrik / Bad Saeckingen, Germany) based on Vita and 3D Master scales and on CIEL*a* b system. Data collected will be evaluated for translucency parameter (TP) and color difference (ΔE) according the thickness and color of the laminate veneers as well as color of dental substrate. The acceptable threshold color difference for the CIEDE2000 method is 1.8 (Paravina et al, 2015). Greater color variation is desirable when a shade match between darker and lighter adjacent tooth substrates is required and values above the clinical thresholds for acceptability of color differences indicating lower masking ability of the material. "Level of Agreement Between the Color Observed by the Operator and the Color Named by the Spectrophotometer" was included as a Primary or Secondary Outcome Measure, but data was not collected. |
after luting the laminate veneers (at least 1 hours after cementation)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FUPelotas
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