Tooth DiscolorationNCT02943395
Color Stability of E.Max CAD Laminate Veneers Cemented With Light Cure Versus Dual Cure Amine Free Adhesive Resin Cement
A study testing E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement and E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement in people with Tooth Discoloration, run by Cairo University.
Trial summary
Light curing cements used for laminate veneers may be not totally cured in certain areas, so dual cured resin cements may solve this problem yet the dual cured cements containing amines cause yellowish discoloration of the veneers after time. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement and E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Mar 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All subjects are required to be:
- From 18-60 years old, and able to read and sign the informed consent document
- physically and psychologically able to tolerate conventional restorative procedures
- Have no active periodontal or pulpal diseases, have teeth with good restorations
- Patients with teeth problems indicated for laminate veneer (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ….)
- Willing to return for follow-up examinations and evaluation
Who cannot join
- Patients in the growth stage with partially erupted teeth
- Patient with fractured teeth of more than 50% enamel loss
- Patients with poor oral hygiene and motivation
- Pregnant women
- Psychiatric problems or unrealistic expectations
- Lack of opposite occluding dentition in the area intended for restoration
Trial locations and contacts
No sites are listed yet.
Jylan elguindy contact
About this study
Light curing cements used for laminate veneers may be not totally cured in certain areas, so dual cured resin cements may solve this problem yet the dual cured cements containing amines cause yellowish discoloration of the veneers after time.
A new dual cured cement which is amine free is introduced so the investigators have to try it clinically using parallel groups in randomized clinical trial.
- Conditions
- Tooth Discoloration
- Being tested
- E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement, E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cementOther
E.Max CAD Laminate Veneers cemented with light cured adhesive resin cementOther
| Study group | Role | What they receive |
|---|---|---|
| dual cure amine free adhesive resin cement | Experimental | resin cement that get activated by both light and chemicals Receives: Other: E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement |
| light cured adhesive resin cement | Active comparator | resin cement that only get activated by light Receives: Other: E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color stability assessed clinically using easy shade vita device
Color stability
Measured: 1 Year
Secondary outcomes (1)
Patient satisfaction assessed using a Questionnaire
Questionnaire for the patient satisfaction
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tooth DiscolorationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahmoud hossam eldin elkomy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943395
- Sponsor's protocol ID
- 17191405
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
Publications
Magalhaes AP, Cardoso Pde C, de Souza JB, Fonseca RB, Pires-de-Souza Fde C, Lopez LG. Influence of activation mode of resin cement on the shade of porcelain veneers. J Prosthodont. 2014 Jun;23(4):291-5. doi: 10.1111/jopr.12098. Epub 2013 Oct 7.
PubMed 24118675Gresnigt MM, Kalk W, Ozcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21.
PubMed 22821429
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Stability of E.Max CAD Laminate Veneers Cemented With Light Cure Versus Dual Cure Amine Free Adhesive Resin Cement
- ClinicalTrials.gov ID
- NCT02943395
- Acronym / sponsor ID
- 17191405
- Conditions
- Tooth Discoloration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Mar 2018 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- 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.
Light curing cements used for laminate veneers may be not totally cured in certain areas, so dual cured resin cements may solve this problem yet the dual cured cements containing amines cause yellowish discoloration of the veneers after time.
A new dual cured cement which is amine free is introduced so the investigators have to try it clinically using parallel groups in randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dual cure amine free adhesive resin cement | Experimental | Other: E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cementresin cement that get activated by both light and chemicals |
| light cured adhesive resin cement | Active comparator | Other: E.Max CAD Laminate Veneers cemented with light cured adhesive resin cementresin cement that only get activated by light |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- From 18-60 years old, and able to read and sign the informed consent document
- physically and psychologically able to tolerate conventional restorative procedures
- Have no active periodontal or pulpal diseases, have teeth with good restorations
- Patients with teeth problems indicated for laminate veneer (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ….)
- Willing to return for follow-up examinations and evaluation
Key exclusion criteria (6 listed)
- Patients in the growth stage with partially erupted teeth
- Patient with fractured teeth of more than 50% enamel loss
- Patients with poor oral hygiene and motivation
- Pregnant women
- Psychiatric problems or unrealistic expectations
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 |
|---|---|---|
| E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement | Other | dual cure amine free adhesive resin cement |
| E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement | Other | light cured adhesive resin cement |
Primary outcome
Color stability assessed clinically using easy shade vita device
Time frame: 1 Year
Color stability
1 secondary outcome
Patient satisfaction assessed using a Questionnaire
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Background: PubMed 24118675Magalhaes AP, Cardoso Pde C, de Souza JB, Fonseca RB, Pires-de-Souza Fde C, Lopez LG. Influence of activation mode of resin cement on the shade of porcelain veneers. J Prosthodont. 2014 Jun;23(4):291-5. doi: 10.1111/jopr.12098. Epub 2013 Oct 7.
- Background: PubMed 22821429Gresnigt MM, Kalk W, Ozcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21.
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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.
Jylan elguindy contact
Questions about this trial
What is this clinical trial studying?
A study testing E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement and E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement in people with Tooth Discoloration, run by Cairo University.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Elkomy, B.D.s (01113735370, mahmoud.hossam919@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color stability assessed clinically using easy shade vita device (time frame: 1 Year). 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 NCT02943395, which also lists 2 linked publications.
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 24 Oct 2016.