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AzTrials

Tooth DiscolorationNCT06404398

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

A study testing OMNICHROMA, Ceram. x spectra in people with Tooth Discoloration, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to clinically evaluate single and multi-shade direct veneers. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Tooth Discoloration
What is being tested?
OMNICHROMA, Ceram. x spectra
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteEgypt
Study dates
19 Jul 2022to 9 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Good hygiene.
  • Vital discolored anterior teeth

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Restorative Department, Faculty of Dentistry, Tanta University

    Tanta, 31527

Other trials in Egypt

About this study

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.

Being tested
OMNICHROMA, Ceram. x spectra
Keywords
OMNICHROMA, Veneers, USPHS criteria
Medical subject headings
Tooth Discoloration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OMNICHROMA, Ceram. x spectraOther

    Each patient had two types of veneers.

Study groups in NCT06404398
Study groupRoleWhat they receive
OMNICHROMAExperimentalone single shade
Receives: Other: OMNICHROMA, Ceram. x spectra
Ceram. x spectraExperimentalmulti- shade
Receives: Other: OMNICHROMA, Ceram. x spectra

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 18 months evaluation periods

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2024
  2. Study start19 Jul 2022
  3. Primary completion5 Feb 2024
  4. Study completion9 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized controlled clinical study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06404398
Sponsor's protocol ID
Direct Composite Resin Veneers
Status last verified
May 2024
First submitted
3 May 2024
Last updated
24 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing OMNICHROMA, Ceram. x spectra in people with Tooth Discoloration, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

assess single and multi-shade direct composite resin veneers (time frame: 18 months evaluation periods). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06404398, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.

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