NCT06472180

Brief Summary

The aim of the study is to assess the marginal adaptation, color stability and clinical performance of glass ceramic sectional veneers compared to full laminate veneers There's two null hypotheses , the first is that there is no difference in the marginal adaptation of sectional and full glass ceramic laminate veneers. the Second is that there is no apparent change in color stability and clinical performance of sectional and full glass ceramic laminate veneers.

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

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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
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 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 25, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 17, 2024

Last Update Submit

June 21, 2024

Conditions

Keywords

Mini-veneerspartial veneersporcelain fragmentssectional veneerslaminate veneers

Outcome Measures

Primary Outcomes (1)

  • Marginal adaptation of sectional and full glass ceramic laminate veneer using digital device intraoral scanner

    assessment of the marginal adaptation using digital device intraoral scanner software

    Baseline,3,6,9,12 months

Secondary Outcomes (2)

  • Color stability

    Baseline,3,6,9,12 months

  • Clinical performance

    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 it is well documented in the literatures as successful restoration modality

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

  • Nehal G Mohamed, 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
double blinded Data analyst, statistician and patient will be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2024

First Posted

June 25, 2024

Study Start

May 1, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations