NCT03129711

Brief Summary

The most frequent reason for failure of laminate veneers made of glass ceramics (feldspathic, leucite based and lithium silicate based ceramics) was fracture of the ceramic, Therefore, ceramic materials that have higher fracture resistance, especially for patients suffering from abnormal occlusion, are needed.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

April 24, 2017

Last Update Submit

April 29, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • fracture resistance

    scores

    1 year

Study Arms (2)

glazed Celtra Duo

EXPERIMENTAL

zirconia reinforced lithium silicate glass ceramic is infiltrated with 10% zirconia by weight, producing zirconia reinforced lithium silicate ceramic

Other: glazed Celtra Duo

Glazed IPS Empress CAD

ACTIVE COMPARATOR

glazed Leucite based glass ceramics ,Its a glass ceramic which is etchable and proved to have good esthetics if used for laminate veneers

Other: IPS Empress CAD

Interventions

zirconia reinforced lithium silicate

glazed Celtra Duo

Standard etchable glass ceramic for laminate veneers

Also known as: Leucite based
Glazed IPS Empress CAD

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All subjects are required to be
  • From 18-50 years old, be 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:
  • Discoloration
  • Fracture not involving more than 50% enamel loss
  • Mild malposition
  • Diastema
  • Enamel fluorosis
  • Stained or defective restorations
  • Willing to return for follow-up examinations and evaluation

You may not qualify if:

  • \. Patients in the growth stage with partially erupted 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. Patient with post and core endodontically treated teeth 6. Psychiatric problems or unrealistic expectations 7. Lack of opposite occluding dentition in the area intended for restoration 8. Patients involved in contact sports 9. Teeth with deep discoloration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth DiscolorationTooth Fractures

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesTooth InjuriesWounds and Injuries

Central Study Contacts

Omnia Wafik El mesallamy, MDS

CONTACT

Jylan El Guindy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 24, 2017

First Posted

April 26, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2018

Study Completion

September 1, 2018

Last Updated

May 2, 2017

Record last verified: 2017-04