Color Stability of Sectional and Full Glass Ceramic Laminate Veneer

June 17, 2024 updated by: Aya mahmoud, October University for Modern Sciences and Arts

Clinical Assessment of the Color Stability of Sectional and Full Glass Ceramic Laminate Veneer by Using Digital Shade Matching Device. A Randomized Clinical Trial

The aim of the study is to evaluate the color stability of full and sectional glass ceramic laminate veneer as esthetic failure is reported to be common failure in laminate following clinical service.

The null hypothesis is that there will be no apparent change in color stability between full and sectional veneer over one year of clinical service

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The success of any esthetic restorative material depends primarily on the color match and then on the color stability of the material. color changes by time reduce the longevity and quality of restorations.

This in vivo study planned to evaluate the color stability of full and sectional glass ceramic laminate veneer using a digital shade device The primary objective of the study to evaluate the color stability of sectional glass ceramic veneer compared to full laminate veneer

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Giza,6th October City
      • Giza, Giza,6th October City, Egypt, 12451
        • October University for Modern Sciences & Arts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Patients seeking for esthetics with the following criteria:

  1. Male or female patients age range above 18 years old
  2. Minor esthetic defects in anterior region
  3. Multiple spacing, diastemas
  4. Incisal fracture
  5. Initial proximal caries
  6. Patients able physically and psychologically to tolerate restorative procedures
  7. Patients willing to return for follow-up examinations and evaluation
  8. Class I occlusion

Exclusion Criteria:

  • Patients free of

    1. Tempromandibular disorders
    2. Para-functional habits
    3. Cracked teeth
    4. Moderate or deep caries
    5. Heavily discolored teeth
    6. Heavy smokers
    7. Enamel defects compromising bonding
    8. Active periodontal disease
    9. Pulpal disease
    10. Mobility
    11. Occlusal disturbances
    12. Class II and III occlusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention- Glass ceramic sectional veneer
participants receive Glass ceramic sectional veneer covering only the area of defect
Procedure: Glass ceramic sectional veneer
partial laminate veneer
Active Comparator: control- Glass ceramic laminate veneer
participants receive laminate veneers made of glass ceramics as a gold standard
Procedure: Glass ceramic laminate veneer
Glass ceramic laminate veneer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Color change
Time Frame: Baseline,3,6,9,12 months
assessment of color change using spectrophotometer
Baseline,3,6,9,12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shade match
Time Frame: Baseline,3,6,9,12 months
assessment of shade match using Modified USPHS
Baseline,3,6,9,12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October University for Modern Sciences and Arts

Investigators

  • Principal Investigator: Aya M Ali, BDS, October University for Modern Sciences & Arts

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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