Tooth DiscolorationNCT02940717
Clinical Evaluation of the Fracture Resistance for E-max Cad and Vita Suprinity Laminate Veneers
A study testing Vita suprinity and Emax CAD in people with Tooth Discoloration, run by Cairo University.
Trial summary
Patients need laminate veneer for their teeth usually use Emax CAD as an etchable ceramic. Yet fracture may occur so a stronger material is needed. Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 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?
- Vita suprinity and Emax CAD
- 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
About this study
Patients need laminate veneer for their teeth usually use Emax CAD as an etchable ceramic. Yet fracture may occur so a stronger material is needed. Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10% by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS) and can be used to fabricate laminate veneers but the investigators have to know clinically it is fracture resistance, so the investigators are going to have Parallel groups in a randomized clinical trial.
- Conditions
- Tooth Discoloration
- Being tested
- Vita suprinity, Emax CAD
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vita suprinityOther
Also called zirconia-reinforced lithium silicate ceramic
New glass ceramic material
Emax CADOther
Also called lithium disilicate glass ceramic
standard etchable glass ceramic used for laminate venneers
| Study group | Role | What they receive |
|---|---|---|
| Vita suprinity | Experimental | Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10 % by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS). Receives: Other: Vita suprinity |
| Emax cad | Active comparator | lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for laminate venners Receives: Other: Emax CAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture resistance assessed by clinical evaluation using dental mirror and probe according to the modified united states public health criteria
clinical evaluation of Fracture resistance
Measured: 1 Year
Secondary outcomes (1)
Patient satisfaction assessed using a Questionnaire
Questionnaire for 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 posted21 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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, Ahmed mohamed osman Youssef, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940717
- Sponsor's protocol ID
- emax_vita
- Status last verified
- Jul 2017
- First submitted
- 19 Oct 2016
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Elsaka SE, Elnaghy AM. Mechanical properties of zirconia reinforced lithium silicate glass-ceramic. Dent Mater. 2016 Jul;32(7):908-14. doi: 10.1016/j.dental.2016.03.013. Epub 2016 Apr 14.
PubMed 27087687Gresnigt 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 22821429Weyhrauch M, Igiel C, Scheller H, Weibrich G, Lehmann KM. Fracture Strength of Monolithic All-Ceramic Crowns on Titanium Implant Abutments. Int J Oral Maxillofac Implants. 2016 Mar-Apr;31(2):304-9. doi: 10.11607/jomi.4601.
PubMed 27004277
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Fracture Resistance for E-max Cad and Vita Suprinity Laminate Veneers
- ClinicalTrials.gov ID
- NCT02940717
- Acronym / sponsor ID
- emax_vita
- 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
- Jan 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 21 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.
Patients need laminate veneer for their teeth usually use Emax CAD as an etchable ceramic. Yet fracture may occur so a stronger material is needed. Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10% by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS) and can be used to fabricate laminate veneers but the investigators have to know clinically it is fracture resistance, so the investigators are going to have Parallel groups in a 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 |
|---|---|---|
| Vita suprinity | Experimental | Other: Vita suprinityVita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10 % by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS). |
| Emax cad | Active comparator | Other: Emax CADlithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for laminate venners |
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 |
|---|---|---|
| Vita suprinityAlso: zirconia-reinforced lithium silicate ceramicNew glass ceramic material | Other | Vita suprinity |
| Emax CADAlso: lithium disilicate glass ceramicstandard etchable glass ceramic used for laminate venneers | Other | Emax cad |
Primary outcome
Fracture resistance assessed by clinical evaluation using dental mirror and probe according to the modified united states public health criteria
Time frame: 1 Year
clinical evaluation of Fracture resistance
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 21 Jul 2017.
- Background: PubMed 27087687Elsaka SE, Elnaghy AM. Mechanical properties of zirconia reinforced lithium silicate glass-ceramic. Dent Mater. 2016 Jul;32(7):908-14. doi: 10.1016/j.dental.2016.03.013. Epub 2016 Apr 14.
- 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.
- Background: PubMed 27004277Weyhrauch M, Igiel C, Scheller H, Weibrich G, Lehmann KM. Fracture Strength of Monolithic All-Ceramic Crowns on Titanium Implant Abutments. Int J Oral Maxillofac Implants. 2016 Mar-Apr;31(2):304-9. doi: 10.11607/jomi.4601.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Vita suprinity and Emax CAD 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 21 Jul 2017. 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?
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?
Fracture resistance assessed by clinical evaluation using dental mirror and probe according to the modified united states public health criteria (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 NCT02940717, which also lists 3 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 21 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.