NCT03713970

Brief Summary

The aim of the present study is to assess the clinical performance (patient satisfaction, fracture, shade matching, Marginal adaptation and sensitivity) of laminate veneers made with celtra duo press ceramic and IPS e.max press ceramic with incisal wrap design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

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 16, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
2.8 years until next milestone

Study Start

First participant enrolled

August 25, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

October 16, 2018

Last Update Submit

February 9, 2024

Conditions

FractureTooth Discoloration

Keywords

cetra duo press,e.max press,clinical performance

Outcome Measures

Primary Outcomes (1)

  • color matching

    shad matching of both laminate veneers made with two materials compared to normal teeth will be evaluated using modified united state public health service criteria (USPHS) 0 Excellent colour match and shade between restoration and adjacent tooth, almost invisible. 1 Slightly mismatching between the restoration and the adjacent tooth, which is in the normal range of tooth colour, translucence and/or shade. 3 Obvious mismatch, beyond the normal range. 4 Gross mismatch/aesthetically displeasing colour, shade and/or translucence.

    0ne year

Secondary Outcomes (4)

  • fracture

    one year

  • patient satisfaction

    one year

  • Marginal adaptation

    one year

  • sensitivity

    one year

Study Arms (2)

Celtra duo press

EXPERIMENTAL

Celtra duo press ingot 20g for three laminate veneers

Procedure: celtra duo pressProcedure: IPS e.max press

IPS e.max press

ACTIVE COMPARATOR

IPS e.max press ingot 20g for three laminate veneers

Procedure: celtra duo pressProcedure: IPS e.max press

Interventions

celtra duo pressPROCEDURE

celtra duo press ingot

Celtra duo pressIPS e.max press
IPS e.max pressPROCEDURE

IPS e.max press ingot

Celtra duo pressIPS e.max press

Eligibility Criteria

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

You may qualify if:

  • All subjects were required to be
  • at least 18 years old
  • able to read and sign the informed consent document
  • physically and psychologically able to tolerate conventional restorative procedures
  • no active periodontal or pulpal diseases and teeth with good restorations
  • teeth problems indicated for laminate veneer (e.g. discoloration, enamel fracture, chipping and mild malposition….)
  • willing to return for follow-up examinations and evaluation
  • Existing composite restorations of good quality, presenting no caries, ditching, or marginal staining were not removed prior to tooth preparation.
  • normal bite (class I Kennedy classification)

You may not qualify if:

  • Patients in the growth stage with partially erupted teeth
  • fractured teeth of more than 50% enamel loss
  • poor oral hygiene and motivation
  • Pregnant women's
  • endodontically treated teeth
  • Psychiatric problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

department of fixed prosthodontic-Cairo university

Cairo, 02, Egypt

Location

Related Publications (3)

  • Alhekeir DF, Al-Sarhan RA, Al Mashaan AF. Porcelain laminate veneers: Clinical survey for evaluation of failure. Saudi Dent J. 2014 Apr;26(2):63-7. doi: 10.1016/j.sdentj.2014.02.003. Epub 2014 Mar 26.

    PMID: 25408598RESULT

  • Chu SJ, Trushkowsky RD, Paravina RD. Dental color matching instruments and systems. Review of clinical and research aspects. J Dent. 2010;38 Suppl 2:e2-16. doi: 10.1016/j.jdent.2010.07.001. Epub 2010 Aug 1.

    PMID: 20621154RESULT

  • Stevenson B, Ibbetson R. The effect of the substructure on the colour of samples/restorations veneered with ceramic: a literature review. J Dent. 2010 May;38(5):361-8. doi: 10.1016/j.jdent.2010.01.009. Epub 2010 Feb 1.

    PMID: 20122985RESULT

MeSH Terms

Conditions

Fractures, BoneTooth Discoloration

Interventions

IPS e.max Press

Condition Hierarchy (Ancestors)

Wounds and InjuriesTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
After examining the participant for eligibility,each participant will be given a number start from one by Shafeq(the main researcher )i.e. each participant will be assigned by numbers and allocated to different groups using these numbers.(for example, the odd numbers to the intervention and the even numbers to the control group)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two groups withe different laminate veneers restorations(celtra duo press and IPS e.max press)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

October 16, 2018

First Posted

October 22, 2018

Study Start

August 25, 2021

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations

EG(1)