NCT06404398

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
Last Updated

July 24, 2024

Status Verified

May 1, 2024

Enrollment Period

1.6 years

First QC Date

May 3, 2024

Last Update Submit

July 22, 2024

Conditions

Keywords

OMNICHROMAVeneersUSPHS criteria

Outcome Measures

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

    18 months evaluation periods

Study Arms (2)

OMNICHROMA

EXPERIMENTAL

one single shade

Other: OMNICHROMA, Ceram. x spectra

Ceram. x spectra

EXPERIMENTAL

multi- shade

Other: OMNICHROMA, Ceram. x spectra

Interventions

Each patient had two types of veneers.

Ceram. x spectraOMNICHROMA

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Good hygiene.
  • Vital discolored anterior teeth

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Restorative Department, Faculty of Dentistry, Tanta University

Tanta, 31527, Egypt

Location

Related Publications (16)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
This clinical study was double-blind study as the evaluators who were not included in the restorative procedures and the patients were blinded to tested groups, but the operator wasn't blinded to these groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled clinical study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

May 3, 2024

First Posted

May 8, 2024

Study Start

July 19, 2022

Primary Completion

February 5, 2024

Study Completion

April 9, 2024

Last Updated

July 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations