- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06404398
Clinical Evaluation of Single Versus Multi-Shade Direct Composite Resin Veneers
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tanta, Egypt, 31527
- Restorative Department, Faculty of Dentistry, Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Good hygiene.
- Vital discolored anterior teeth
Exclusion Criteria:
- severe discoloration
- Para functional activities
- Non-vital teeth.
- Pregnancy
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
one single shade
|
Each patient had two types of veneers.
|
|
Experimental: Ceram. x spectra
multi- shade
|
Each patient had two types of veneers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assess single and multi-shade direct composite resin veneers
Time Frame: 18 months evaluation periods
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Direct Composite Resin 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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