Shade Matching of Universal Versus Conventional Nanohybrid Resin Composites in Class IV Restorations After Bleaching
August 4, 2024 updated by: Nayra Mohamed Mohab El Din Hussein Mohamed, Cairo University
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 .
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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
Study Type
Interventional
Enrollment (Estimated)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nayra Halim, Msc student
- Phone Number: +201112417351
- Email: nayra.halim@dentistry.cu.edu.eg
Study Contact Backup
- Name: Ahmed Refaat, phd
- Phone Number: 01146464696
- Email: ahmed.refaat@dentistry.cu.edu.eg
Study Locations
-
-
-
Cairo, Egypt, 12613
- Recruiting
- Faculty of Dentistry, Cairo University
-
Contact:
- Faculty of dentistry cairo university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: One shade universal composite
shade matching 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
|
|
Active Comparator: Nanohybrid resin composite
Conventional Nanohybrid resin composite
|
A conventional resin composite with multiple shades
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in shade matching
Time Frame: Baseline, 2 days, 3, 6 and 12 months
|
Modified USPHS criteria with Alpha, Bravo ,Charlie and Delta scores (Categorical)
|
Baseline, 2 days, 3, 6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Marginal discoloration
Time Frame: Baseline, 2 days, 3, 6 and 12 months
|
Modified USPHS criteria with Alpha, Bravo, Charlie and Delta scores (Categorical)
|
Baseline, 2 days, 3, 6 and 12 months
|
|
Change in surface texture
Time Frame: Baseline, 2 days, 3, 6 and 12 months
|
Modified USPHS criteria with Alpha, Bravo, Charlie and Delta scores (Categorical)
|
Baseline, 2 days, 3, 6 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: ahmed El Zoheiry, prof, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 12, 2023
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
October 1, 2025
Study Registration Dates
First Submitted
November 27, 2022
First Submitted That Met QC Criteria
November 27, 2022
First Posted (Actual)
December 6, 2022
Study Record Updates
Last Update Posted (Actual)
August 6, 2024
Last Update Submitted That Met QC Criteria
August 4, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Universal composite
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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