NCT04774614

Brief Summary

It is assumed that there will be no difference in shade match, marginal adaptation and patient satisfaction between VITA ENAMIC multiColor and IPS e.max CAD anterior laminate veneers.

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
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

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

January 17, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

January 17, 2021

Last Update Submit

February 24, 2021

Conditions

Shade Match

Outcome Measures

Primary Outcomes (1)

  • shade match

    measured by Modified United States Public Health Service criteria (USPHS criteria). Score Alpha (A): matches tooth, Bravo (B): acceptable mismatch, Charlie (C): unacceptable mismatch

    immediately after restoration delivery

Secondary Outcomes (2)

  • marginal adaptation

    immediately after restoration delivery

  • patient satisfaction

    immediately after restoration delivery

Study Arms (2)

VITA ENAMIC multiColor anterior laminate veneers

EXPERIMENTAL
Procedure: anterior laminate veneers

IPS e.max CAD anterior laminate veneers

ACTIVE COMPARATOR
Procedure: anterior laminate veneers

Interventions

anterior laminate veneersPROCEDURE

VITA ENAMIC multiColor

IPS e.max CAD anterior laminate veneersVITA ENAMIC multiColor anterior laminate veneers

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-55 years, are able to read and sign the informed consent document.
  • Patients who are physically and psychologically able to tolerate conventional restorative procedures.
  • Patients with no active periodontal or pulpal diseases and have teeth with good restorations.
  • Patients with complaints related to the esthetics in the upper or lower teeth (e.g. discoloration, fracture that does not involve more than 50% enamel loss, mild malposition)

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.
  • Patient with non-vital teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
PhD candidate

Study Record Dates

First Submitted

January 17, 2021

First Posted

March 1, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

March 1, 2021

Record last verified: 2021-02