ClinicalTrials.gg
Status unknownNCT03136276Updated May 2, 2017

One Year Clinical Evaluation of IPS Empress CAD Versus Polished Celtra Duo Ceramic Laminate Veneers

An interventional study of IPS Empress CAD and polished Celtra Duo in Tooth Discoloration, Tooth Fractures and Diastema, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-05-02.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tooth Discoloration
  • Tooth Fractures
  • Diastema
03

In context

Tooth Discoloration

105 studies on the registry are indexed under Tooth Discoloration; 19 are open to participants now.

This study's planned enrollment of 36 is below the median of 48 across 97 interventional studies indexed under Tooth Discoloration.

Browse Tooth Discoloration studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All subjects are required to be:

  1. From 18-50 years old, be able to read and sign the document.
  2. Have no active periodontal or pulpal diseases, have teeth with good restorations
  3. Psychologically and physically able to tolerate conventional dental procedures
  4. Patients with teeth problems indicated for laminate veneer:

    1. Discoloration
    2. Fracture not involving more than 50% enamel loss
    3. Mild malposition
    4. Diastema
    5. Enamel fluorosis
    6. Stained or defective restorations
  5. Able to return for follow-up examinations and evaluation

Exclusion criteria

Exclusion Criteria:

  1. Patient with post and core endodontically treated teeth
  2. Patient with fractured teeth of more than 50% enamel loss
  3. Patients with poor oral hygiene and motivation
  4. Pregnant women's
  5. Patients in the growth stage with partially erupted teeth
  6. Psychiatric problems or unrealistic expectations
  7. Lack of opposing dentition in the area of interest
  8. Patients involved in contact sports
  9. Teeth with deep discoloration
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Active comparator
    IPS Empress CAD

    Leucite Based glass Ceramics which is etchable ceramics and proved to have good success rate if used for laminate veneers

    Other: IPS Empress CAD

  • Experimental
    polished Celtra Duo

    Zirconia reinforced lithium silicate, it is a recent material with glass ceramics enriched with 10% zirconia that offers high strength properties

    Other: polished Celtra Duo

Interventions

  • OtherIPS Empress CAD

    standard etchable glass ceramics

    Also known as: leucite based glass ceramics

  • Otherpolished Celtra Duo

    new glass ceramic material

    Also known as: zirconia reinforced lithium silicate (ZLS)

06

What researchers measure

Primary outcomes

  1. Fracture

    number of fractured laminates

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2017; primary completion for Jul 2018, 12 months later.

Of 44 non-industry interventional studies with no phase under Tooth Discoloration, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's planned 12 months is above that.

Counting every sponsor, half of 52 studies reached it within 8 months; a quarter within 2 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2017
First posted
May 2, 2017
StartEst.
Jul 2017
Primary completionEst.
Jul 2018
CompletionEst.
Sep 2018
Last update
May 2, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03136276
Lead sponsor
Cairo University
Responsible party
Hayat Ibrahim Mahrous Ibrahim (assisstant lecturer, fixed prosthodontic department, faculty of oral and dental medicine, Cairo University) — Principal investigator
First posted
May 2, 2017
Start date
Jul 2017 (estimated)
Primary completion
Jul 2018 (estimated)
Completion
Sep 2018 (estimated)
Last update
May 2, 2017

Study contacts

Hayat El-Banna, M.D.s
Contact
hayat.elbanna@dentistry.cu.edu.eg
01001248734
Jylan EL-Guindy
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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