Discoloration, ToothNCT03086928
One Year Clinical Evaluation of E-max CAD and Lava Ultimate Laminate Veneers
A study testing lava ultimate and E.max cad in people with Discoloration, Tooth, run by Cairo University.
Trial summary
Restoration of anterior teeth using conservative approach allows clinicians to provide porcelain laminate veneers with excellent esthetics without extensive tooth structure removal. laminate veneers need the use of etch-able ceramics like glass ceramics (E.max) and hybrid ceramics (Lava Ultimate). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Discoloration, Tooth
- What is being tested?
- lava ultimate and E.max cad
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Apr 2017to Apr 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- From 18-50 years old, be able to read and sign the informed consent document.
- Be 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, defect not involve more than 60% enamel loss, mild malposition, anterior upper….).
- Be 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 60% 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.
kareem abo bakr, PHD contact
About this study
Official title: One Year Clinical Evaluation of E-max CAD and Lava Ultimate Laminate Veneers With Butt Joint Preparation
Restoration of anterior teeth using conservative approach allows clinicians to provide porcelain laminate veneers with excellent esthetics without extensive tooth structure removal. laminate veneers need the use of etch-able ceramics like glass ceramics (E.max) and hybrid ceramics (Lava Ultimate). The aim of this study is to compare both e.max and lava ultimate veneers clinically.
Read the detailed description
The use of E-max CAD well documented in the literatures as successful restoration modality which has superior optical and mechanical properties. The introduction of hybrid ceramic materials combined the advantages of both glass ceramics and composite resin. Resin nano-ceramic is a mixture of a resin composite matrix and nano-ceramic fillers of approximately 80% by weight. The main advantages of this material over the glass ceramics are the stress absorbing action or stress distribution by having modulus of elasticity near to the tooth dentin and can be individualized intra-orally or extra-orally, either before or after definitive cementation.
Yet there are no studies for clinical evaluation of both mentioned laminate veneers restorations. This study is conducted to compare between both materials clinically according to modified USPHS criteria in terms of marginal adaptation, fracture, debonding, marginal discoloration and patient satisfaction.
- Conditions
- Discoloration, Tooth
- Being tested
- lava ultimate, E.max 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.
lava ultimateOther
resin nano ceramic material
E.max cadOther
Lithium disilicate glass ceramic
| Study group | Role | What they receive |
|---|---|---|
| lava ultimate | Experimental | lava ultimate is Resin nano-ceramic which is a mixture of a resin composite matrix and nano-ceramic fillers of approximately 80% by weight. The main advantages of this material over the glass ceramics are the stress absorbing action or stress distribution by having modulus of elasticity near to the tooth dentin and can be individualized intra-orally or extra-orally, either before or after definitive cementation. Receives: Other: lava ultimate |
| E.max cad | Active comparator | E.max is lithium disilicate glass ceramic, composed of quartz, lithium dioxide, phosphor oxide, alumina oxide, and potassium oxide with superior mechanical and optical properties if used for laminate veneers Receives: Other: E.max cad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction evaluated by using a questionnaire
Patient satisfaction will be evaluated by using a questionnaire, which will be translated. A validation of the Arabic translation will be done before using the questionnaire in the trial. Each participant will take the questionnaire into a quiet room and will be left alone until questionnaire is totally answered.
Measured: one year
Secondary outcomes (1)
Modified USPHS criteria
It is a criteria for clinical evaluation of dental restorative materials in terms of marginal adaptation, marginal discoloration, fracture, debonding.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study startApr 2017 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionApr 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 Discoloration, ToothStudies 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, Mai Mohamed Eltohami, Cairo University
- Investigators
- amina zaki, PHD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086928
- Sponsor's protocol ID
- CEBC-CU-2017-3-12
- Status last verified
- Mar 2017
- First submitted
- 9 Mar 2017
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pimentel W, Teixeira ML, Costa PP, Jorge MZ, Tiossi R. Predictable Outcomes with Porcelain Laminate Veneers: A Clinical Report. J Prosthodont. 2016 Jun;25(4):335-40. doi: 10.1111/jopr.12413. Epub 2015 Dec 3.
PubMed 26633080D'Arcangelo C, De Angelis F, Vadini M, D'Amario M. Clinical evaluation on porcelain laminate veneers bonded with light-cured composite: results up to 7 years. Clin Oral Investig. 2012 Aug;16(4):1071-9. doi: 10.1007/s00784-011-0593-0. Epub 2011 Jul 20.
PubMed 21773711
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Clinical Evaluation of E-max CAD and Lava Ultimate Laminate Veneers With Butt Joint Preparation
- ClinicalTrials.gov ID
- NCT03086928
- Acronym / sponsor ID
- CEBC-CU-2017-3-12
- Conditions
- Discoloration, Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2017 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 22 Mar 2017 (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.
Restoration of anterior teeth using conservative approach allows clinicians to provide porcelain laminate veneers with excellent esthetics without extensive tooth structure removal. laminate veneers need the use of etch-able ceramics like glass ceramics (E.max) and hybrid ceramics (Lava Ultimate). The aim of this study is to compare both e.max and lava ultimate veneers clinically.
Detailed description
The use of E-max CAD well documented in the literatures as successful restoration modality which has superior optical and mechanical properties. The introduction of hybrid ceramic materials combined the advantages of both glass ceramics and composite resin. Resin nano-ceramic is a mixture of a resin composite matrix and nano-ceramic fillers of approximately 80% by weight. The main advantages of this material over the glass ceramics are the stress absorbing action or stress distribution by having modulus of elasticity near to the tooth dentin and can be individualized intra-orally or extra-orally, either before or after definitive cementation.
Yet there are no studies for clinical evaluation of both mentioned laminate veneers restorations. This study is conducted to compare between both materials clinically according to modified USPHS criteria in terms of marginal adaptation, fracture, debonding, marginal discoloration and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lava ultimate | Experimental | Other: lava ultimatelava ultimate is Resin nano-ceramic which is a mixture of a resin composite matrix and nano-ceramic fillers of approximately 80% by weight. The main advantages of this material over the glass ceramics are the stress absorbing action or stress distribution by having modulus of elasticity near to the tooth dentin and can be individualized intra-orally or extra-orally, either before or after definitive cementation. |
| E.max cad | Active comparator | Other: E.max cadE.max is lithium disilicate glass ceramic, composed of quartz, lithium dioxide, phosphor oxide, alumina oxide, and potassium oxide with superior mechanical and optical properties if used for laminate veneers |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- From 18-50 years old, be able to read and sign the informed consent document.
- Be 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, defect not involve more than 60% enamel loss, mild malposition, anterior upper….).
- Be 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 60% 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 |
|---|---|---|
| lava ultimateresin nano ceramic material | Other | lava ultimate |
| E.max cadLithium disilicate glass ceramic | Other | E.max cad |
Primary outcome
Patient satisfaction evaluated by using a questionnaire
Time frame: one year
Patient satisfaction will be evaluated by using a questionnaire, which will be translated. A validation of the Arabic translation will be done before using the questionnaire in the trial. Each participant will take the questionnaire into a quiet room and will be left alone until questionnaire is totally answered.
1 secondary outcome
Modified USPHS criteria
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Background: PubMed 26633080Pimentel W, Teixeira ML, Costa PP, Jorge MZ, Tiossi R. Predictable Outcomes with Porcelain Laminate Veneers: A Clinical Report. J Prosthodont. 2016 Jun;25(4):335-40. doi: 10.1111/jopr.12413. Epub 2015 Dec 3.
- Background: PubMed 21773711D'Arcangelo C, De Angelis F, Vadini M, D'Amario M. Clinical evaluation on porcelain laminate veneers bonded with light-cured composite: results up to 7 years. Clin Oral Investig. 2012 Aug;16(4):1071-9. doi: 10.1007/s00784-011-0593-0. Epub 2011 Jul 20.
- 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.
kareem abo bakr, PHD contact
amina zaki, PHD study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing lava ultimate and E.max cad in people with Discoloration, Tooth, 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 5 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 22 Mar 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?
Contact mai elgendi, B.D.S (201126811001, mai.eltohami@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction evaluated by using a questionnaire (time frame: one 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 NCT03086928, 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 22 Mar 2017.