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

Tooth Discoloration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06404398
• Other study ID #: Direct Composite Resin Veneers
• Status: Completed
• Phase: N/A
• Start date: July 19, 2022
• Est. completion date: April 9, 2024

Study information

• Verified date: May 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to clinically evaluate the single versus multi-shade direct composite resin veneers.

Description:

For several decades, growing demands have boosted the use of direct resin composites in esthetic restorative dentistry. The recent advances in adhesive dentistry have resulted in the development of materials and techniques for restoring the natural teeth appearance, particularly in the anterior region. The introduction of more esthetic and natural tooth structure mimicking materials can enable the clinicians to imitate the natural dental tissues to produce very natural-looking restorations.

Many clinical issues such as tooth discoloration, extensive fractures, misaligned teeth and carious lesions may cause an important impairment in esthetic appearance and smile harmony which ultimately impacts the quality of life. The use of direct composite resin veneers may be a fascinating option to recover the esthetic appearance of damaged teeth as they actually allow the operator to monitor and assess the entire restorative procedure from shade selection to final morphology.

Direct veneering with composite resins involves applying resin directly to the prepared tooth surfaces and artistically sculpting them to rectify aesthetic defects of color, anatomy, and morphology. Direct composite veneering has many advantages, such as being a chair-side technique, not requiring multiple appointments or luting agents, being minimally invasive, preserving natural tooth structure, being easily repaired and cost-effective due to no laboratory costs were involved. In addition, they have similar abrasion rates as those of natural tooth structures.

The color variation of natural teeth prompted manufacturers to fabricate composite resins with several shades, frequently utilizing the Vita Classical shade guide as a reference. Moreover, resin composites are available in a wide range of opacities, usually named dentin, body or opaque, and enamel or translucent. They seek to emulate dentin and enamel's optical characteristics, which are indicated for different areas of the tooth.

The layering technique for resin composite restorations has been recommended since 1980. In order to mimic the optical features of a natural tooth; this procedure involves the use of composites with different chroma and opacities for each layer. Even while the layering technique has been proven to yield satisfactory results for color matching, this approach is much more complex than a regular two or one shade technique, requiring excellent restorative skills and an extended chair-side time.

Composite materials and restorative techniques that enable the use of streamlined clinical protocols are highly desirable among clinicians in order to save chair time, minimize technique sensitivity and enhance the final aesthetically pleasing results. Since color selection might be challenging and subjected to environmental and operator-dependent variables, a tendency to simplify shade selection has resulted in the fabrication of so-called universal composites. These composites have a universal opacity and few Vita shades available, being recommended by developers to be used in a single shade increment that may be able to match varying tooth shades.

Recently, smart chromatic technology was employed to develop OMNICHROMA, a unique single-shade resin restorative composite that has 260 nm spherical fillers and a similar appearance to the surrounding tooth structure. Its broad color matching ability may eliminate the need for a shade assessment procedure and reduce the inventory of resin composites, enabling clinicians to reduce chair time, the wastage of unused resin composite shades, and their reliance on shade selection techniques.

Clinical testing of the restorative materials is crucial to determine their durability when compared to in vitro screening. Even with meticulously designed simulations of clinical circumstances in vitro tests, the conditions differ markedly from those in vivo. In the oral cavity, several interactive clinical variables pertaining to the tooth substrate and oral environment such as the outward flow of fluids through the dentinal tubules, the surface tension and others which cannot be simulated with in vitro tests. The null hypothesis of this study is that there is no significant difference in the clinical performance between single versus multi-shade direct composite resin veneers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 9, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Good oral hygiene.

• Vital anterior teeth with at least four discolored teeth due to intrinsic discoloration such as fluorosis, mild tetracycline stain, hypoplasia or cracks.

• Good periodontal health.

• Availability for follow up recalls

Exclusion Criteria:

• Patients with bad oral hygiene.

• Patients on medication that can alter the color of the teeth.

• Extreme discoloration of teeth which cannot be treated by direct composite veneer.

• Any para functional habits such as tooth clenching or grinding.

• Non-vital or endodontically treated teeth.

• Pregnancy

Related Conditions & MeSH terms

• Tooth Discoloration

Intervention

Other:
• OMNICHROMA, Ceram. x spectra
Each patient received at least one pair of the 2 types of direct veneers, as the central incisors received the same type of veneer material in order to avoid possible noticeable shade differences. Sixteen patients treated with 64 direct veneers for upper incisors. While, four patients treated with 24 direct veneers for upper incisors and canines.A total of 88 direct composite veneers were divided in to two equal groups (n = 44) as follow: Group (I): OMNICHROMA single shade. Group (II): Ceram. x spectra™ ST multi- shade

Locations

Country	Name	City	State
Egypt	Restorative Department, Faculty of Dentistry, Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. Poly — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinically evaluate the single versus multi-shade direct composite resin veneers	Two calibrated examiners evaluated the veneer restorations clinically at baseline (after 24 hours), 6, 9, 12 and 18 months, according to modified United States Public Health Service criteria USPHS for teeth hypersensitivity, fracture of restoration, marginal adaptation, marginal discoloration, surface texture, color match, anatomical form and secondary caries.The majority of veneer restorations were scored according to modified United States Public Health Service USPHS criteria as follows: (Score0) represented the ideal clinical situation, (Score1) was clinically acceptable, (Score2) was questionable, and (Score3) and (Score4) were considered clinically unacceptable situations where the restoration has to be repaired or replaced	18 months evaluation periods