NCT06470945

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

May 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 17, 2024

Last Update Submit

June 17, 2024

Conditions

Keywords

porcelain fragmentsminiveneerssectional veneerslaminate veneerspartial veneers

Outcome Measures

Primary Outcomes (1)

  • Color change

    assessment of color change using spectrophotometer

    Baseline,3,6,9,12 months

Secondary Outcomes (1)

  • shade match

    Baseline,3,6,9,12 months

Study Arms (2)

intervention- Glass ceramic sectional veneer

EXPERIMENTAL

participants receive Glass ceramic sectional veneer covering only the area of defect

Procedure: Glass ceramic sectional veneer

control- Glass ceramic laminate veneer

ACTIVE COMPARATOR

participants receive laminate veneers made of glass ceramics as a gold standard

Procedure: Glass ceramic laminate veneer

Interventions

partial laminate veneer

intervention- Glass ceramic sectional veneer

Glass ceramic laminate veneer

control- Glass ceramic laminate veneer

Eligibility Criteria

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

You may qualify if:

  • Patients seeking for esthetics with the following criteria:
  • Male or female patients age range above 18 years old
  • Minor esthetic defects in anterior region
  • Multiple spacing, diastemas
  • Incisal fracture
  • Initial proximal caries
  • Patients able physically and psychologically to tolerate restorative procedures
  • Patients willing to return for follow-up examinations and evaluation
  • Class I occlusion

You may not qualify if:

  • Patients free of
  • Tempromandibular disorders
  • Para-functional habits
  • Cracked teeth
  • Moderate or deep caries
  • Heavily discolored teeth
  • Heavy smokers
  • Enamel defects compromising bonding
  • Active periodontal disease
  • Pulpal disease
  • Mobility
  • Occlusal disturbances
  • Class II and III occlusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October University for Modern Sciences & Arts

Giza, Giza,6th October City, 12451, Egypt

Location

Study Officials

  • Aya M Ali, BDS

    October University for Modern Sciences & Arts

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Data analyst and statistician will be blinded and The patient will be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 17, 2024

First Posted

June 24, 2024

Study Start

May 1, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

June 24, 2024

Record last verified: 2024-06

Locations