Color; Change Teeth, PosteruptiveNCT06368869
The Effect of Different Types of Resin Cements on the Color Stability of Two Different Types of Ceramic Veneers
A study testing Livento press veneers luted with dual cured resin cement, Livento press veneers luted with light cured resin cement and Celtra duo veneers luted with dual cured resin cement in people with Color; Change Teeth, Posteruptive, run by amr elshimy at 1 site in Egypt.
Trial summary
Aim of the study was to evaluate the color stability of lithium disilicate ceramic veneers and zirconia reinforced lithium silicate ceramic veneers by using two different types of resin cements including light cured and dual cured cements. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Color; Change Teeth, Posteruptive
- What is being tested?
- Livento press veneers luted with dual cured resin cement, Livento press veneers luted with light cured resin cement and Celtra duo veneers luted with dual cured resin cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2023to 20 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Good oral hygiene with compliance to perform strict oral hygiene measures (periodontal screening index 0-1).
- Slight malposition.
- Teeth with spacing.
- Teeth with discoloration
Who cannot join
- Advanced periodontitis, gingivitis, or recession.
- Abutments with subgingival restorations or root caries.
- Parafunctional habits.
- Undergoing orthodontic treatment.
- Presence of orthodontic appliance.
- Obvious dentition malalignment.
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- Mandibular prognathism.
- Maxillary retrognathism.
- Smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Types of Resin Cements on the Color Stability of Two Different Types of Ceramic Veneers (Randomized Controlled Clinical Trial)
Aim of the study was to evaluate the color stability of lithium disilicate ceramic veneers and zirconia reinforced lithium silicate ceramic veneers by using two different types of resin cements including light cured and dual cured cements.
- Conditions
- Color; Change Teeth, Posteruptive
- Being tested
- Livento press veneers luted with dual cured resin cement, Livento press veneers luted with light cured resin cement, Celtra duo veneers luted with dual cured resin cement, Celtra duo veneers luted with light cured resin cement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Livento press veneers luted with dual cured resin cementOther
Veneers will be fabricated using Lithium disilicate (Livento® Press) ceramic and luted using Bifix QM dual cured cement
Livento press veneers luted with light cured resin cementOther
Veneers will be fabricated using Lithium disilicate (Livento® Press) ceramic and luted using Bisco choice 2 light cured cement
Celtra duo veneers luted with dual cured resin cementOther
Veneers will be fabricated using Zirconia-reinforced lithium silicate (Celtra® Press) ceramic and luted using Bifix QM dual cured cement
Celtra duo veneers luted with light cured resin cementOther
Veneers will be fabricated using Zirconia-reinforced lithium silicate (Celtra® Press) ceramic and luted Bisco choice 2 light cured cement
| Study group | Role | What they receive |
|---|---|---|
| Livento press veneers luted with dual cured resin cement | Experimental | Not described Receives: Other: Livento press veneers luted with dual cured resin cement |
| Livento press veneers luted with light cured resin cement | Active comparator | Not described Receives: Other: Livento press veneers luted with light cured resin cement |
| Celtra duo veneers luted with dual cured resin cement | Experimental | Not described Receives: Other: Celtra duo veneers luted with dual cured resin cement |
| Celtra duo veneers luted with light cured resin cement | Active comparator | Not described Receives: Other: Celtra duo veneers luted with light cured resin cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color stability assessment
VITA Easyshade® Advance spectrophotometer will be used to measure the shade on the CIELab system, which defines color on 3 axes: L*, lightness, ranging from 0 (black) to 100 (white); and a* and b*, chromatic characteristics ranging from red (+a*) to green (-a*) and yellow (+b*) to blue (-b*) The color will be measured 3 times, and the mean L*, a*, and b* values will be calculated and used to measure color change (delta E)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start10 Jan 2023
- Primary completion20 Jan 2024
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Color; Change Teeth, PosteruptiveStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- amr elshimy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, amr elshimy, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368869
- Sponsor's protocol ID
- #1/2022
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Types of Resin Cements on the Color Stability of Two Different Types of Ceramic Veneers (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06368869
- Acronym / sponsor ID
- #1/2022
- Conditions
- Color; Change Teeth, Posteruptive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- amr elshimyUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study was to evaluate the color stability of lithium disilicate ceramic veneers and zirconia reinforced lithium silicate ceramic veneers by using two different types of resin cements including light cured and dual cured cements.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Livento press veneers luted with dual cured resin cement | Experimental | Other: Livento press veneers luted with dual cured resin cement |
| Livento press veneers luted with light cured resin cement | Active comparator | Other: Livento press veneers luted with light cured resin cement |
| Celtra duo veneers luted with dual cured resin cement | Experimental | Other: Celtra duo veneers luted with dual cured resin cement |
| Celtra duo veneers luted with light cured resin cement | Active comparator | Other: Celtra duo veneers luted with light cured resin cement |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Good oral hygiene with compliance to perform strict oral hygiene measures (periodontal screening index 0-1).
- Slight malposition.
- Teeth with spacing.
- Teeth with discoloration
Key exclusion criteria (9 listed)
- Advanced periodontitis, gingivitis, or recession.
- Abutments with subgingival restorations or root caries.
- Parafunctional habits.
- Undergoing orthodontic treatment.
- Presence of orthodontic appliance.
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 |
|---|---|---|
| Livento press veneers luted with dual cured resin cementVeneers will be fabricated using Lithium disilicate (Livento® Press) ceramic and luted using Bifix QM dual cured cement | Other | Livento press veneers luted with dual cured resin cement |
| Livento press veneers luted with light cured resin cementVeneers will be fabricated using Lithium disilicate (Livento® Press) ceramic and luted using Bisco choice 2 light cured cement | Other | Livento press veneers luted with light cured resin cement |
| Celtra duo veneers luted with dual cured resin cementVeneers will be fabricated using Zirconia-reinforced lithium silicate (Celtra® Press) ceramic and luted using Bifix QM dual cured cement | Other | Celtra duo veneers luted with dual cured resin cement |
| Celtra duo veneers luted with light cured resin cementVeneers will be fabricated using Zirconia-reinforced lithium silicate (Celtra® Press) ceramic and luted Bisco choice 2 light cured cement | Other | Celtra duo veneers luted with light cured resin cement |
Primary outcome
Color stability assessment
Time frame: up to 12 months
VITA Easyshade® Advance spectrophotometer will be used to measure the shade on the CIELab system, which defines color on 3 axes: L*, lightness, ranging from 0 (black) to 100 (white); and a* and b*, chromatic characteristics ranging from red (+a*) to green (-a*) and yellow (+b*) to blue (-b*) The color will be measured 3 times, and the mean L*, a*, and b* values will be calculated and used to measure color change (delta E)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Livento press veneers luted with dual cured resin cement, Livento press veneers luted with light cured resin cement and Celtra duo veneers luted with dual cured resin cement in people with Color; Change Teeth, Posteruptive, run by amr elshimy at 1 site in Egypt.
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 4 inclusion and 9 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 16 Apr 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Color stability assessment (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2024.