Optical Properties of Laminate VeneersNCT02464540
Optical Properties of Light Cured Luting Agent on Laminate Veneer
A study testing Laminate veneers luted with light-cured resin cement and Laminate veneers luted with light-cured flowable composite in people with Optical Properties of Laminate Veneers, run by Federal University of Pelotas at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optical Properties of Laminate Veneers
- What is being tested?
- Laminate veneers luted with light-cured resin cement and Laminate veneers luted with light-cured flowable composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with extensive loss of tooth structure
- Subjects suffering from temporomandibular disorders, neurological and oral mucosa diseases
- Inadequate oral hygiene or periodontal problems
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial of Light Cured Luting Agents on Laminate Veneers
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.
Read the detailed 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.
- Conditions
- Optical Properties of Laminate Veneers
- Being tested
- Laminate veneers luted with light-cured resin cement, Laminate veneers luted with light-cured flowable composite
- Keywords
- laminate veneers, luting agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laminate veneers luted with light-cured resin cementProcedure or surgery
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.
Laminate veneers luted with light-cured flowable compositeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Light-cured resin cement | Active comparator | Laminate veneers luted using light-cured resin cement Receives: Procedure: Laminate veneers luted with light-cured resin cement |
| Light-cured flowable composite | Active comparator | Laminate veneers luted using light-cured flowable composite Receives: Procedure: Laminate veneers luted with light-cured flowable composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (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.
Measured: after luting the laminate veneers (at least 1 hours after cementation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2016
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Optical Properties of Laminate VeneersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noéli Boscato, PhD, Federal University of Pelotas
- Investigators
- Noéli Boscato, PhD, Principal investigator, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464540
- Sponsor's protocol ID
- FUPelotas
- Status last verified
- Feb 2020
- First submitted
- 8 May 2015
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Perroni AP, Barbon FJ, Chaves ET, Alberton da Silva S, de Moraes RR, Boscato N. Exploring the influence of tooth, ceramic, and resin luting agent variations on laminate veneer optical characteristics: a prospective clinical investigation. Clin Oral Investig. 2024 Nov 12;28(12):639. doi: 10.1007/s00784-024-06032-3.
PubMed 39528774
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Light Cured Luting Agents on Laminate Veneers
- ClinicalTrials.gov ID
- NCT02464540
- Acronym / sponsor ID
- FUPelotas
- Conditions
- Optical Properties of Laminate Veneers
- Keywords
- laminate veneers, luting agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Posted 17 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light-cured resin cement | Active comparator | Procedure: Laminate veneers luted with light-cured resin cementLaminate veneers luted using light-cured resin cement |
| Light-cured flowable composite | Active comparator | Procedure: Laminate veneers luted with light-cured flowable compositeLaminate veneers luted using light-cured flowable composite |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Minimum 18 years of age
- Patients with diastema
- Conoid teeth
- Misaligned anterior teeth
- Discolored teeth and/or teeth with erosion/abrasion
Key exclusion criteria (4 listed)
- Patients with extensive loss of tooth structure
- Subjects suffering from temporomandibular disorders, neurological and oral mucosa diseases
- Inadequate oral hygiene or periodontal problems
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laminate veneers luted with light-cured resin cementAfter 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. | Procedure or surgery | Light-cured resin cement |
| Laminate veneers luted with light-cured flowable compositeAfter 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. | Procedure or surgery | Light-cured flowable composite |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39528774Perroni AP, Barbon FJ, Chaves ET, Alberton da Silva S, de Moraes RR, Boscato N. Exploring the influence of tooth, ceramic, and resin luting agent variations on laminate veneer optical characteristics: a prospective clinical investigation. Clin Oral Investig. 2024 Nov 12;28(12):639. doi: 10.1007/s00784-024-06032-3.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noéli Boscato, PhD principal investigator
Federal University of Pelotas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laminate veneers luted with light-cured resin cement and Laminate veneers luted with light-cured flowable composite in people with Optical Properties of Laminate Veneers, run by Federal University of Pelotas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optical Properties of Laminate Veneers (time frame: after luting the laminate veneers (at least 1 hours after cementation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02464540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.