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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02464540
Other study ID # FUPelotas
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2015
Est. completion date March 2018

Study information

Verified date February 2020
Source Federal University of Pelotas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this randomized clinical trial is to evaluate the influence of luting agent, thickness and color of laminate veneers (LVs) and color of dental substrate on the optical properties of LVs.


Description:

The following date will be collected (i) the color of dental substrate obtained before and after dental preparation, (ii) the thickness and color of the LVs obtained before of the cementation procedures on white and black value background, (iii) and the final color of the LVs bonded to dental substrates obtained after cementation. For LVs cementation two cements will be used, the light-cured resin cement and the flowable composite, which will be randomly divided into two groups (n=31). The color of LVs 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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date March 2018
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Optical Properties of Laminate Veneers

Intervention

Procedure:
Laminate veneers luted with 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 (?E) 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.
Laminate veneers luted with 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 (?E) 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.

Locations

Country Name City State
Brazil Noéli Boscato Pelotas RS

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Optical Properties of Laminate Veneers 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 (?E) 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)