Shade Matching of Universal Versus Conventional Nanohybrid Resin Composites in Class IV Restorations After Bleaching

Anterior Teeth Clinical Trial

Official title:

Clinical Evaluation of Shade Matching and Marginal Discoloration of One Shade Universal Resin Composite Versus Conventional Nanohybrid Resin Composite in Class IV Restorations Before and After Tooth Bleaching .

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638373
• Other study ID #: Universal composite
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: November 2023
• Source: Cairo University
• Contact: Nayra Halim, Msc student
• Phone: +201112417351
• Email: nayra.halim[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the current study is to assess the shade matching potential of single shade universal resin composite versus conventional nanohybrid resin composite in class IV restorations after bleaching

Description:

The use of a dental material that can blend into the surrounding tooth structure is increasing in popularity . A new technology , smart chromatic technology , has been introduced as the shade matching composite called omnichroma . Omnichroma has the ability to match the new lighter shade of the bleached teeth unlike the conventional composite . In this study , an investigation will be done to evaluate if this new technology will help to preserve the tooth structure and be more conservative , by avoiding the removal of the old anterior restorations after bleaching

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Candidates must have one or more existing class IV restoration.

• Cases indicated for bleaching.

• Cooperative patient approving to participate in the trial.

Exclusion Criteria:

• Patients with severe medical conditions that might interfere with the study.

• Patients with rampant caries or xerostomia.

• Smoking.

• Patients with history of hydrogen peroxide sensitivity , periodontal inflammation.

• Lack of compliance.

• Tempromandibular joint disorders.

• Disabilities.

Related Conditions & MeSH terms

• Anterior Teeth

Intervention

Other:
• One shade universal composite
A resin composite with new smart chromatic technology and chameleon effect. It has the ability to match the new lighter shade of the bleached teeth unlike the conventional composite
• Nanohybrid resin composite
A conventional resin composite with multiple shades

Locations

Country	Name	City	State
Egypt	Faculty of dentistry, cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

Ameedee AAL, Ragab H, Essam E, et al.(2016): Clinical evaluation of in-office tooth bleaching effects on three contemporary composite resins. J Dent Health Oral Disord Ther., 5(6):350-357.

Bayne SC, Schmalz G. Reprinting the classic article on USPHS evaluation methods for measuring the clinical research performance of restorative materials. Clin Oral Investig. 2005 Dec;9(4):209-14. doi: 10.1007/s00784-005-0017-0. No abstract available. — View Citation

Elzayat, G. A., Elsayed, M. E., & El Zoghby, A. (2020): Clinical Performance of Direct Anterior Composite Restorations Using Esthetic Dual-Shade versus Polychromatic Natural Layering Technique: a split mouth randomized controlled clinical trial. Brazilian Dental Science, 23(4), 12-12.

Evans, M. B. (2020):The Visual and Spectrophotometric Effect of External Bleaching on OMNICHROMA Resin Composite and Natural Teeth. West Virginia University.

Mohamed, M. A., Afutu, R., Tran, D., Dunn, K., Ghanem, J., Perry, R., & Kugel, G. (2020): Shade Matching Capacity of Omnichroma in Anterior Restorations. Journal of Dental Sciences., 5(1), 1-6.

Mourouzis P, Koulaouzidou EA, Helvatjoglu-Antoniades M. Effect of in-office bleaching agents on physical properties of dental composite resins. Quintessence Int. 2013 Apr;44(4):295-302. doi: 10.3290/j.qi.a29154. — View Citation

Pereira Sanchez N, Powers JM, Paravina RD. Instrumental and visual evaluation of the color adjustment potential of resin composites. J Esthet Restor Dent. 2019 Sep;31(5):465-470. doi: 10.1111/jerd.12488. Epub 2019 May 16. — View Citation

Telang A, Narayana IH, Madhu KS, Kalasaiah D, Ramesh P, Nagaraja S. Effect of Staining and Bleaching on Color stability and Surface Roughness of Three Resin Composites: An in vitro study. Contemp Clin Dent. 2018 Jul-Sep;9(3):452-456. doi: 10.4103/ccd.ccd_297_18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in shade matching	Modified USPHS criteria with Alpha, Bravo ,Charlie and Delta scores (Categorical)	Baseline, 2 days, 3, 6 and 12 months
Secondary	Change in Marginal discoloration	Modified USPHS criteria with Alpha, Bravo, Charlie and Delta scores (Categorical)	Baseline, 2 days, 3, 6 and 12 months
Secondary	Change in surface texture	Modified USPHS criteria with Alpha, Bravo, Charlie and Delta scores (Categorical)	Baseline, 2 days, 3, 6 and 12 months