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

NCT03136276 | Unknown

• 1 other identifier: 19786
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tooth Discoloration; Tooth Fractures; Diastema

Outcome Measures

Primary Outcomes (1)

• Fracture

  number of fractured laminates

  1 year

Study Arms (2)

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

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

Other: polished Celtra Duo

Interventions

IPS Empress CAD OTHER

standard etchable glass ceramics

Also known as: leucite based glass ceramics

IPS Empress CAD

polished Celtra Duo OTHER

new glass ceramic material

Also known as: zirconia reinforced lithium silicate (ZLS)

polished Celtra Duo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• 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
• 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

You may not qualify if:

• 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
• Lack of opposing dentition in the area of interest
• Patients involved in contact sports
• Teeth with deep discoloration

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Tooth Discoloration; Tooth Fractures; Diastema

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Tooth Injuries; Wounds and Injuries; Tooth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Hayat El-Banna, M.D.s

CONTACT

01001248734; hayat.elbanna@dentistry.cu.edu.eg

Jylan EL-Guindy

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant lecturer, fixed prosthodontic department, faculty of oral and dental medicine

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: May 2, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: May 2, 2017

Record last verified: 2017-04