Shade Matching of Universal Versus Conventional Nanohybrid Resin Composites in Class IV Restorations After Bleaching
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 .
1 other identifier
interventional
32
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2022
CompletedFirst Posted
Study publicly available on registry
December 6, 2022
CompletedStudy Start
First participant enrolled
September 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedAugust 6, 2024
August 1, 2024
1.4 years
November 27, 2022
August 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in shade matching
Modified USPHS criteria with Alpha, Bravo ,Charlie and Delta scores (Categorical)
Baseline, 2 days, 3, 6 and 12 months
Secondary Outcomes (2)
Change in Marginal discoloration
Baseline, 2 days, 3, 6 and 12 months
Change in surface texture
Baseline, 2 days, 3, 6 and 12 months
Study Arms (2)
One shade universal composite
EXPERIMENTALshade matching composite
Nanohybrid resin composite
ACTIVE COMPARATORConventional Nanohybrid resin composite
Interventions
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
A conventional resin composite with multiple shades
Eligibility Criteria
You may qualify if:
- Candidates must have one or more existing class IV restoration.
- Cases indicated for bleaching.
- Cooperative patient approving to participate in the trial.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of dentistry, cairo university
Cairo, 12613, Egypt
Related 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.
BACKGROUNDBayne 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.
PMID: 16421996BACKGROUNDElzayat, 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.
BACKGROUNDEvans, M. B. (2020):The Visual and Spectrophotometric Effect of External Bleaching on OMNICHROMA Resin Composite and Natural Teeth. West Virginia University.
BACKGROUNDMohamed, 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.
BACKGROUNDMourouzis 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.
PMID: 23479582BACKGROUNDPereira 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.
PMID: 31095870BACKGROUNDTelang 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.
PMID: 30166843BACKGROUND
Study Officials
- STUDY DIRECTOR
ahmed El Zoheiry, prof
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master degree candidate, Department of Conservative Dentistry, Faculty of Dentistry
Study Record Dates
First Submitted
November 27, 2022
First Posted
December 6, 2022
Study Start
September 12, 2023
Primary Completion
February 1, 2025
Study Completion
October 1, 2025
Last Updated
August 6, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share