NCT02940717

Brief Summary

Patients need laminate veneer for their teeth usually use Emax CAD as an etchable ceramic. Yet fracture may occur so a stronger material is needed. Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10% by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS) and can be used to fabricate laminate veneers but the investigators have to know clinically it is fracture resistance, so the investigators are going to have Parallel groups in a randomized clinical trial.

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
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

October 19, 2016

Last Update Submit

July 18, 2017

Conditions

Tooth Discoloration

Outcome Measures

Primary Outcomes (1)

  • Fracture resistance assessed by clinical evaluation using dental mirror and probe according to the modified united states public health criteria

    clinical evaluation of Fracture resistance

    1 Year

Secondary Outcomes (1)

  • Patient satisfaction assessed using a Questionnaire

    1 Year

Study Arms (2)

Vita suprinity

EXPERIMENTAL

Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10 % by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS).

Other: Vita suprinity

Emax cad

ACTIVE COMPARATOR

lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for laminate venners

Other: Emax CAD

Interventions

Vita suprinityOTHER

New glass ceramic material

Also known as: zirconia-reinforced lithium silicate ceramic
Vita suprinity
Emax CADOTHER

standard etchable glass ceramic used for laminate venneers

Also known as: lithium disilicate glass ceramic
Emax 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 18-60 years old, and 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 (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ….)
  • Willing to return for follow-up examinations and evaluation

You may not qualify if:

  • Patients in the growth stage with partially erupted teeth
  • Patient with fractured teeth of more than 50% 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Elsaka SE, Elnaghy AM. Mechanical properties of zirconia reinforced lithium silicate glass-ceramic. Dent Mater. 2016 Jul;32(7):908-14. doi: 10.1016/j.dental.2016.03.013. Epub 2016 Apr 14.

    PMID: 27087687BACKGROUND

  • Gresnigt MM, Kalk W, Ozcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21.

    PMID: 22821429BACKGROUND

  • Weyhrauch M, Igiel C, Scheller H, Weibrich G, Lehmann KM. Fracture Strength of Monolithic All-Ceramic Crowns on Titanium Implant Abutments. Int J Oral Maxillofac Implants. 2016 Mar-Apr;31(2):304-9. doi: 10.11607/jomi.4601.

    PMID: 27004277BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration

Interventions

VITA Suprinity

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

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
Internal resident at fixed prothodontics department faculty of oral and dental medicine cairo university

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 21, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

March 1, 2018

Last Updated

July 21, 2017

Record last verified: 2017-07