NCT05465850

Brief Summary

The aim of the study is to clinically evaluate the shade matching and clinical performance of the Universal shade composites Omnichroma and GC Essentia versus the multi shade composite Filtek Z350XT in restoring cervical lesions of anterior teeth.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

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

First Submitted

Initial submission to the registry

June 27, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

June 27, 2022

Last Update Submit

July 16, 2022

Conditions

Class V Dental Caries

Outcome Measures

Primary Outcomes (3)

  • Clinical performance (USPHS criteria)

    USPHS criteria

    baseline: 1 week

  • Clinical performance (USPHS criteria)

    USPHS criteria

    6 months

  • Clinical performance (USPHS criteria)

    USPHS criteria

    12 months

Study Arms (3)

Filtek Z350XT

ACTIVE COMPARATOR
Diagnostic Test: Modified USPHS criteria

Essentia universal shade, GC composite

EXPERIMENTAL
Diagnostic Test: Modified USPHS criteria

Omnichroma composite

EXPERIMENTAL
Diagnostic Test: Modified USPHS criteria

Interventions

Modified USPHS criteriaDIAGNOSTIC_TEST

It assess the restorations with visual inspection using a mirror and explorer. It includes Marginal integrity, shade matching, retention, marginal discoloration, gingival inflammation, and recurrent caries.

Essentia universal shade, GC compositeFiltek Z350XTOmnichroma composite

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Class V carious lesions in anterior teeth
  • Vital upper or lower anterior teeth with no signs of irreversible pulpitis and necrosis.
  • Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth

You may not qualify if:

  • Deep carious defects ( Close to pulp, less than 1 mm distance)
  • Periapical pathology or signs of pulpal pathology
  • Endodontically treated teeth
  • Tooth hypersensitivity
  • Possible prosthodontic restoration of teeth
  • Heavy occlusion and occlusal contacts or history of bruxism
  • Severe periodontal affection
  • Lesions in premolars and molars
  • Posterior 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
Principal Investigator

Study Record Dates

First Submitted

June 27, 2022

First Posted

July 20, 2022

Study Start

August 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share