NCT04840524

Brief Summary

Conservatism is considered the main concern in any treatment plan, the feather edge preparation design of laminate veneers have been introduced yet clinical studies are lacking to evaluate their clinical performance.The aim of this study is to evaluate the effect of the two different preparation designs on the functional and esthetic outcome of laminate veneers in terms of marginal adaptation, retention, fracture, marginal discoloration and patient satisfaction

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 26, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

1.9 years

First QC Date

April 7, 2021

Last Update Submit

June 17, 2021

Conditions

Keywords

LaminatesVertical preparationveneers

Outcome Measures

Primary Outcomes (1)

  • marginal gap distance

    the gap between the laminate and the prepared tooth is measured before cementation using silicon replica and digital microscope

    at time of laminate cementation

Study Arms (2)

Conventional preparation design (Chamfer finish line with Butt joint incisal preparation design)

OTHER

conventional treatment

Procedure: Laminate veneers preparation

New preparation design (Feather edge finish line with feather edge incisal preparation design)

EXPERIMENTAL

New preparation design

Procedure: Laminate veneers preparation

Interventions

facial laminate veneers teeth preparation

Conventional preparation design (Chamfer finish line with Butt joint incisal preparation design)New preparation design (Feather edge finish line with feather edge incisal preparation design)

Eligibility Criteria

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

You may qualify if:

  • From 18-60 years old, and able to read and sign the informed consent document.
  • Patients with teeth problems indicated for laminate veneers.
  • Physically and psychologically able to tolerate conventional restorative procedures.
  • Have no active periodontal or pulpal diseases.
  • Maintenance of good oral hygiene .
  • Willing to return for follow-up examinations and evaluation.

You may not qualify if:

  • Patients in the growth stage with partially erupted teeth.
  • Patients with para-functional habits.
  • Cases that need modification in the incisal edge.
  • Patients with poor oral hygiene and motivation .
  • Psychiatric problems or unrealistic expectations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry - Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Tooth Discoloration

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
Assosiate lecturer of Fixed Prosthodontics

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 12, 2021

Study Start

January 26, 2021

Primary Completion

January 1, 2023

Study Completion

July 1, 2023

Last Updated

June 18, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations