- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06543654
Evaluation of Template Assisted Monochromatic Structural Colored Versus Universal Multi-Shade Direct Composite Veneers
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tanta, Egypt
- Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- better dental hygiene
- discolored vital anterior teeth
Exclusion Criteria:
- Para functional activities
- Non-vital teeth
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Omnichroma
Monochromatic structural colored composite
|
Each participants had two kinds of veneers
Ceram. X Spectra
|
|
Experimental: Ceram. X Spectra
Universal multi shade composite
|
Each participants had two kinds of veneers
Ceram. X Spectra
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: eighteen months
|
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.
|
eighteen months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Direct veneers
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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