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Status unknownNCT05465850Updated Jul 20, 2022

Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth

An interventional study of Modified USPHS criteria in Class V Dental Caries, sponsored by Cairo University. Status unknown. Open to participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
25 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Class V Dental Caries

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03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Filtek Z350XT

    Diagnostic Test: Modified USPHS criteria

  • Experimental
    Essentia universal shade, GC composite

    Diagnostic Test: Modified USPHS criteria

  • Experimental
    Omnichroma composite

    Diagnostic Test: Modified USPHS criteria

Interventions

  • Diagnostic testModified USPHS criteria

    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.

06

What researchers measure

Primary outcomes

  1. Clinical performance (USPHS criteria)

    USPHS criteria

    Time frame: baseline: 1 week

  2. Clinical performance (USPHS criteria)

    USPHS criteria

    Time frame: 6 months

  3. Clinical performance (USPHS criteria)

    USPHS criteria

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05465850
Lead sponsor
Cairo University
Responsible party
Dina Khaled Mokhtar Mohamed (Principal Investigator, Cairo University) — Principal investigator
First posted
Jul 20, 2022
Start date
Aug 2022 (estimated)
Primary completion
Aug 2023 (estimated)
Completion
Aug 2023 (estimated)
Last update
Jul 20, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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