Tooth DiscolorationNCT03136276
One Year Clinical Evaluation of IPS Empress CAD Versus Polished Celtra Duo Ceramic Laminate Veneers
A study testing IPS Empress CAD and polished Celtra Duo in people with Tooth Discoloration and Tooth Fractures, run by Cairo University.
Trial summary
When restoring teeth with IPS Empress laminate veneers, fracture of restorations may occur. So, material with higher mechanical properties is required. Celtra Duo is a new material with glass ceramics infiltrated by 10% zirconia particles which increase the fracture resistance of the material. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tooth Discoloration, Tooth Fractures, Diastema
- What is being tested?
- IPS Empress CAD and polished Celtra Duo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Sep 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
- No healthy volunteers
- Adult
Who may be able to join
- All subjects are required to be:
- From 18-50 years old, be able to read and sign the informed consent document.
- Have no active periodontal or pulpal diseases, have teeth with good restorations
- Psychologically and physically able to tolerate conventional dental procedures
- Patients with teeth problems indicated for laminate veneer:
- Discoloration
Show all 12Show fewer
- Fracture not involving more than 50% enamel loss
- Mild malposition
- Diastema
- Enamel fluorosis
- Stained or defective restorations
- Able to return for follow-up examinations and evaluation
Who cannot join
- Patient with post and core endodontically treated teeth
- Patient with fractured teeth of more than 50% enamel loss
- Patients with poor oral hygiene and motivation
- Pregnant women's
- Patients in the growth stage with partially erupted teeth
- Psychiatric problems or unrealistic expectations
Show all 9Show fewer
- Lack of opposing dentition in the area of interest
- Patients involved in contact sports
- Teeth with deep discoloration
Trial locations and contacts
No sites are listed yet.
Jylan EL-Guindy contact
About this study
When restoring teeth with IPS Empress laminate veneers, fracture of restorations may occur. So, material with higher mechanical properties is required. Celtra Duo is a new material with glass ceramics infiltrated by 10% zirconia particles which increase the fracture resistance of the material.
- Conditions
- Tooth Discoloration, Tooth Fractures, Diastema
- Being tested
- IPS Empress CAD, polished Celtra Duo
- Medical subject headings
- Tooth Discoloration, Tooth Fractures, Diastema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPS Empress CADOther
Also called leucite based glass ceramics
standard etchable glass ceramics
polished Celtra DuoOther
Also called zirconia reinforced lithium silicate (ZLS)
new glass ceramic material
| Study group | Role | What they receive |
|---|---|---|
| IPS Empress CAD | Active comparator | Leucite Based glass Ceramics which is etchable ceramics and proved to have good success rate if used for laminate veneers Receives: Other: IPS Empress CAD |
| polished Celtra Duo | Experimental | Zirconia reinforced lithium silicate, it is a recent material with glass ceramics enriched with 10% zirconia that offers high strength properties Receives: Other: polished Celtra Duo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture
number of fractured laminates
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 posted2 May 2017
- Study startJul 2017 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayat Ibrahim Mahrous Ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136276
- Sponsor's protocol ID
- 19786
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2017
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Clinical Evaluation of IPS Empress CAD Versus Polished Celtra Duo Ceramic Laminate Veneers
- ClinicalTrials.gov ID
- NCT03136276
- Acronym / sponsor ID
- 19786
- Conditions
- Tooth Discoloration, Tooth Fractures, Diastema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 2 May 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.
When restoring teeth with IPS Empress laminate veneers, fracture of restorations may occur. So, material with higher mechanical properties is required. Celtra Duo is a new material with glass ceramics infiltrated by 10% zirconia particles which increase the fracture resistance of the material.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPS Empress CAD | Active comparator | Other: IPS Empress CADLeucite Based glass Ceramics which is etchable ceramics and proved to have good success rate if used for laminate veneers |
| polished Celtra Duo | Experimental | Other: polished Celtra DuoZirconia reinforced lithium silicate, it is a recent material with glass ceramics enriched with 10% zirconia that offers high strength properties |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- From 18-50 years old, be able to read and sign the informed consent document.
- Have no active periodontal or pulpal diseases, have teeth with good restorations
- Psychologically and physically able to tolerate conventional dental procedures
- Patients with teeth problems indicated for laminate veneer:
- Able to return for follow-up examinations and evaluation
Key exclusion criteria (9 listed)
- Patient with post and core endodontically treated teeth
- Patient with fractured teeth of more than 50% enamel loss
- Patients with poor oral hygiene and motivation
- Pregnant women's
- Patients in the growth stage with partially erupted teeth
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 |
|---|---|---|
| IPS Empress CADAlso: leucite based glass ceramicsstandard etchable glass ceramics | Other | IPS Empress CAD |
| polished Celtra DuoAlso: zirconia reinforced lithium silicate (ZLS)new glass ceramic material | Other | polished Celtra Duo |
Primary outcome
Fracture
Time frame: 1 year
number of fractured laminates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- 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.
Jylan EL-Guindy contact
Questions about this trial
What is this clinical trial studying?
A study testing IPS Empress CAD and polished Celtra Duo in people with Tooth Discoloration and Tooth Fractures, 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 12 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: status not confirmed, as of the sponsor's last update on 2 May 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 Hayat El-Banna, M.D.s (01001248734, hayat.elbanna@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture (time frame: 1 year). 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 2 May 2017.