ClinicalTrials.gg
CompletedNCT06543654Updated Aug 9, 2024

Evaluation of Template Assisted Monochromatic Structural Colored Versus Universal Multi-Shade Direct Composite Veneers

An interventional study of Omnichroma and Ceram. X Spectra in Tooth Discoloration, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-09.

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

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Jul 2022, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

The aim of this study was to conduct a clinical trial utilizing a modified split-mouth, double-blinded, randomized strategy to clinically assess template assisted one shade structural colored versus universal multi-shade direct composite veneers

Read the detailed description

The superior mechanical qualities, superb aesthetics, and versatility of resin-based composites (RBCs) make them popular choices for direct restorative applications. Compared to their predecessors, nanocomposites have shown superior qualities since nanotechnology was introduced in the production of dental RBCs.

A restoration's aesthetic integration is mostly the result of its chromatic characteristics. Pigments included in the composition of the restorative material typically control the selective reflection of wavelengths to emulate the natural tooth. In order to better reflect the broad color range that characterizes real dentition, RBCs have more recently employed the phenomena of "structural color" .

Thanks to the novel property of resins, color differences between the tooth and the restoration are eliminated or balanced out as perceived color of a region moves toward the color of the surrounding area . Additionally, as opposed to multi-shade RBCs, single-shade RBCs eliminate the need to select between various resin shades, streamlining the color choosing procedure and cutting down on time lost during the clinical resin selection process. The Vita Classic Shade Guide's shades can all be matched with these materials.

02

Conditions studied

  • Tooth Discoloration

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03

In context

Tooth Discoloration

107 studies on the registry are indexed under Tooth Discoloration; 19 are open to participants now.

This study's enrollment of 20 is below the median of 46 across 99 interventional studies indexed under Tooth Discoloration.

Browse Tooth Discoloration studies →

Lead sponsor

Tanta University is the lead sponsor of 991 studies on the registry; 316 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • better dental hygiene
  • discolored vital anterior teeth

Exclusion criteria

Exclusion Criteria:

  • Para functional activities
  • Non-vital teeth
05

Study design

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

Study arms

  • Experimental
    Omnichroma

    Monochromatic structural colored composite

    Other: Omnichroma · Other: Ceram. X Spectra

  • Experimental
    Ceram. X Spectra

    Universal multi shade composite

    Other: Omnichroma · Other: Ceram. X Spectra

Interventions

  • OtherOmnichroma

    Each participants had two kinds of veneers

  • OtherCeram. X Spectra

    Ceram. X Spectra

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What researchers measure

Primary outcomes

  1. Clinical evaluation was performed at baseline, six, nine, twelve, and eighteen months by two calibrated examiners using modified United States Public Health Service (USPHS) criteria

    The perfect clinical scenario was represented by a score of 0, clinically acceptable by a score of 1, dubious by a score of 2, and clinically unsatisfactory by a score of 3 and 4.

    Time frame: eighteen months

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Study locations

1 site
  • Faculty of Dentistry
    Tanta, Egypt
08

References and documents

Publications

  • Kobayashi S, Nakajima M, Furusawa K, Tichy A, Hosaka K, Tagami J. Color adjustment potential of single-shade resin composite to various-shade human teeth: Effect of structural color phenomenon. Dent Mater J. 2021 Jul 31;40(4):1033-1040. doi: 10.4012/dmj.2020-364. Epub 2021 Apr 20. PubMed 33883353 ↗
  • Arai Y, Kurokawa H, Takamizawa T, Tsujimoto A, Saegusa M, Yokoyama M, Miyazaki M. Evaluation of structural coloration of experimental flowable resin composites. J Esthet Restor Dent. 2021 Mar;33(2):284-293. doi: 10.1111/jerd.12674. Epub 2020 Oct 24. PubMed 33098228 ↗
  • Furusawa K, Kobayashi S, Yamashita A, Tichy A, Hosaka K, Shimada Y, Nakajima M. Effect of filler load on structural coloration and color adjustment potential of resin composites. Dent Mater J. 2023 May 30;42(3):343-350. doi: 10.4012/dmj.2022-199. Epub 2023 Jan 28. PubMed 36709985 ↗
  • Kam Hepdeniz O, Temel UB. Clinical survival of No-prep indirect composite laminate veneers: a 7-year prospective case series study. BMC Oral Health. 2023 May 3;23(1):257. doi: 10.1186/s12903-023-02949-5. PubMed 37138297 ↗
  • Castro FLA, Durand LB. Influence of cavity wall thickness on the color adjustment potential of single-shade resin composites. J Am Dent Assoc. 2024 Jul;155(7):605-613. doi: 10.1016/j.adaj.2024.03.006. Epub 2024 May 31. PubMed 38819355 ↗
  • Miranda AO, Favoreto MW, Matos TP, Castro AS, Kunz P, Souza JL, Carvalho P, Reis A, Loguercio AD. Color Match of a Universal-shade Composite Resin for Restoration of Non-carious Cervical Lesions: An Equivalence Randomized Clinical Trial. Oper Dent. 2024 Jan 1;49(1):20-33. doi: 10.2341/23-021-C. PubMed 38057996 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06543654
Lead sponsor
Tanta University
Responsible party
Mohammed Abd El Ghany Mohammed (Assistant lecturer, Tanta University) — Principal investigator
First posted
Aug 9, 2024
Start date
Jul 19, 2022
Primary completion
Feb 5, 2024
Completion
Apr 9, 2024
Last update
Aug 9, 2024

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 completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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