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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05638373
Other study ID # Universal composite
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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