ClinicalTrials.gg
CompletedNCT06404398Updated Jul 24, 2024

Clinical Evaluation of Single Versus Multi-Shade Direct Composite Resin Veneers

An interventional study of OMNICHROMA, 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. Per ClinicalTrials.gov, last updated 2024-07-24.

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

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jul 2022, registered May 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 clinically evaluate single and multi-shade direct veneers.

Read the detailed description

The use of direct, light-activated resin composites in esthetic restorative dentistry has grown dramatically in response to growing needs. Recent developments have resulted in the creation of restorative materials and methods that, particularly in the anterior area, attempt to restore the natural appearance of the teeth.

Numerous clinical conditions, including tooth discolorations, severe fractures, misaligned teeth, and dental caries lesions, can significantly affect smile harmony and esthetic appearance, which can lower quality of life.

Modern cosmetic dentistry began with the introduction of laminate veneers in the 1970s, which combined the ideas of tooth conservation and aesthetics. Because laminate veneers (LVs) offer the potential to satisfy the need for extremely beautiful, minimally invasive, long-lasting restorations with superior clinical performance, they have gained popularity as a treatment option.

Direct composite veneering preserves natural tooth structure, may be completed chairside, doesn't require repeated appointments, doesn't require luting agents, is minimally invasive, readily repaired, and is less expensive because there are no laboratory fees. Furthermore, their abrasion rates are comparable to those of real tooth structures.

02

Conditions studied

  • Tooth Discoloration

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Keywords

  • OMNICHROMA
  • Veneers
  • USPHS criteria
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
No

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

  • Good hygiene.
  • Vital discolored anterior teeth

Exclusion criteria

Exclusion Criteria:

  • severe discoloration
  • Para functional activities
  • Non-vital teeth.
  • Pregnancy
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

    one single shade

    Other: OMNICHROMA, Ceram. x spectra

  • Experimental
    Ceram. x spectra

    multi- shade

    Other: OMNICHROMA, Ceram. x spectra

Interventions

  • OtherOMNICHROMA, Ceram. x spectra

    Each patient had two types of veneers.

06

What researchers measure

Primary outcomes

  1. assess single and multi-shade direct composite resin veneers

    Two evaluators assessed the restorations based on modified United States Public Health Service criteria. Score(0) represents ideal clinical scenario, Score(1) acceptable, Score (2) satisfactory, and Score(3) and Score (4) considered clinically unsatisfactory

    Time frame: 18 months evaluation periods

07

Study locations

1 site
  • Restorative Department, Faculty of Dentistry, Tanta University
    Tanta, 31527, Egypt
08

References and documents

Publications

  • Blatz MB, Chiche G, Bahat O, Roblee R, Coachman C, Heymann HO. Evolution of Aesthetic Dentistry. J Dent Res. 2019 Nov;98(12):1294-1304. doi: 10.1177/0022034519875450. PubMed 31633462 ↗
  • Araujo E, Perdigao J. Anterior Veneer Restorations - An Evidence-based Minimal-Intervention Perspective. J Adhes Dent. 2021 Apr 7;23(2):91-110. doi: 10.3290/j.jad.b1079529. PubMed 33825424 ↗
  • Akgul S, Gundogdu C, Bala O. Effects of storage time and restoration depth on instrumental color adjustment potential of universal resin composites. J Oral Sci. 2022 Jan 19;64(1):49-52. doi: 10.2334/josnusd.21-0290. Epub 2021 Dec 15. PubMed 34911896 ↗
  • Chen F, Toida Y, Islam R, Alam A, Chowdhury AFMA, Yamauti M, Sano H. Evaluation of shade matching of a novel supra-nano filled esthetic resin composite employing structural color using simplified simulated clinical cavities. J Esthet Restor Dent. 2021 Sep;33(6):874-883. doi: 10.1111/jerd.12671. Epub 2020 Nov 14. PubMed 33188588 ↗
  • Attia YS, Sherif RM, Zaghloul HH. Survival of Hybrid Laminate Veneers using two different tooth preparation techniques: Randomized Clinical Trial. Braz Dent J. 2021 Nov-Dec;32(6):36-53. doi: 10.1590/0103-6440202103907. PubMed 35019018 ↗
  • Fahl N Jr,, Ritter AV. Composite veneers: The direct-indirect technique revisited. J Esthet Restor Dent. 2021 Jan;33(1):7-19. doi: 10.1111/jerd.12696. Epub 2020 Dec 18. PubMed 33336852 ↗
  • Gresnigt MMM, Cune MS, Jansen K, van der Made SAM, Ozcan M. Randomized clinical trial on indirect resin composite and ceramic laminate veneers: Up to 10-year findings. J Dent. 2019 Jul;86:102-109. doi: 10.1016/j.jdent.2019.06.001. Epub 2019 Jun 7. PubMed 31181242 ↗
  • 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 ↗
  • Haak R, Bruckner A, Hafer M, Scholz M, Schneider H. Is There an Association Between Clinical and SEM Quantitative Marginal Analysis in a 90-month Trial? J Adhes Dent. 2021;23(1):37-46. doi: 10.3290/j.jad.b916821. PubMed 33512114 ↗
  • Ojeda G D, Naves LZ, Oosterhaven A, Kleinsman R, Baumer-Konig A, Korner G, Wendler M, Gresnigt M. 8-year multicenter retrospective study on partial laminate veneers. J Prosthodont Res. 2023 Apr 12;67(2):206-213. doi: 10.2186/jpr.JPR_D_22_00079. Epub 2022 Jul 5. PubMed 35793984 ↗
  • Ahmed MA, Jouhar R, Khurshid Z. Smart Monochromatic Composite: A Literature Review. Int J Dent. 2022 Nov 8;2022:2445394. doi: 10.1155/2022/2445394. eCollection 2022. PubMed 36398065 ↗
  • Yagci O, Fidan M. Influence of Thickness on the Translucency Parameter and Whiteness Index of Single-Shade Resin Composites. Oper Dent. 2024 Mar 1;49(2):189-199. doi: 10.2341/23-053-L. PubMed 38349843 ↗
  • Korkut B, Unal T, Can E. Two-year retrospective evaluation of monoshade universal composites in direct veneer and diastema closure restorations. J Esthet Restor Dent. 2023 Apr;35(3):525-537. doi: 10.1111/jerd.12992. Epub 2022 Dec 7. PubMed 36478098 ↗
  • Hayashi S, Homma S, Takanashi T, Hirano T, Yoshinari M, Yajima Y. Wear properties of esthetic dental materials against translucent zirconia. Dent Mater J. 2019 Mar 31;38(2):250-256. doi: 10.4012/dmj.2018-133. Epub 2018 Dec 11. PubMed 30541995 ↗
  • Yilmaz Atali P, Dogu Kaya B, Manav Ozen A, Tarcin B, Senol AA, Tuter Bayraktar E, Korkut B, Bilgin Gocmen G, Tagtekin D, Turkmen C. Assessment of Micro-Hardness, Degree of Conversion, and Flexural Strength for Single-Shade Universal Resin Composites. Polymers (Basel). 2022 Nov 17;14(22):4987. doi: 10.3390/polym14224987. PubMed 36433113 ↗
  • Hampe-Kautz V, Salehi A, Senger B, Etienne O. A comparative in vivo study of new shade matching procedures. Int J Comput Dent. 2020;23(4):317-323. PubMed 33491927 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2022 to primary completion in Feb 2024, 18 months.

Of 46 non-industry interventional studies with no phase under Tooth Discoloration, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 18. This study's 18 months is above that.

Counting every sponsor, half of 55 studies reached it within 8 months; a quarter within 2 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
May 3, 2024
First posted
May 8, 2024
StartActual
Jul 19, 2022
Primary completionActual
Feb 5, 2024
CompletionActual
Apr 9, 2024
Last update
Jul 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06404398
Lead sponsor
Tanta University
Responsible party
Mohammed Abd El Ghany Mohammed (Assistant lecturer, Tanta University) — Principal investigator
First posted
May 8, 2024
Start date
Jul 19, 2022
Primary completion
Feb 5, 2024
Completion
Apr 9, 2024
Last update
Jul 24, 2024

Oversight

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

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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