Anterior TeethNCT05638373
Shade Matching of Universal Versus Conventional Nanohybrid Resin Composites in Class IV Restorations After Bleaching
A study testing One shade universal composite and Nanohybrid resin composite in people with Anterior Teeth, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Teeth
- What is being tested?
- One shade universal composite and Nanohybrid resin composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Sep 2023to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Candidates must have one or more existing class IV restoration.
- Cases indicated for bleaching.
- Cooperative patient approving to participate in the trial.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry, cairo university
Cairo, 12613
Faculty of dentistry cairo university
About this study
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 .
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
Read the 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
- Conditions
- Anterior Teeth
- Being tested
- One shade universal composite, Nanohybrid resin composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One shade universal compositeOther
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 compositeOther
A conventional resin composite with multiple shades
| Study group | Role | What they receive |
|---|---|---|
| One shade universal composite | Experimental | shade matching composite Receives: Other: One shade universal composite |
| Nanohybrid resin composite | Active comparator | Conventional Nanohybrid resin composite Receives: Other: Nanohybrid resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in shade matching
Modified USPHS criteria with Alpha, Bravo ,Charlie and Delta scores (Categorical)
Measured: Baseline, 2 days, 3, 6 and 12 months
Secondary outcomes (2)
Change in Marginal discoloration
Modified USPHS criteria with Alpha, Bravo, Charlie and Delta scores (Categorical)
Measured: Baseline, 2 days, 3, 6 and 12 months
Change in surface texture
Modified USPHS criteria with Alpha, Bravo, Charlie and Delta scores (Categorical)
Measured: Baseline, 2 days, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start12 Sep 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anterior TeethStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayra Mohamed Mohab El Din Hussein Mohamed, Cairo University
- Investigators
- ahmed El Zoheiry, prof, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638373
- Sponsor's protocol ID
- Universal composite
- Status last verified
- Aug 2024
- First submitted
- 27 Nov 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16421996Elzayat, 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.
PubMed 23479582Pereira 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.
PubMed 31095870Telang 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.
PubMed 30166843
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 .
- ClinicalTrials.gov ID
- NCT05638373
- Acronym / sponsor ID
- Universal composite
- Conditions
- Anterior Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One shade universal composite | Experimental | Other: One shade universal compositeshade matching composite |
| Nanohybrid resin composite | Active comparator | Other: Nanohybrid resin compositeConventional Nanohybrid resin composite |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Candidates must have one or more existing class IV restoration.
- Cases indicated for bleaching.
- Cooperative patient approving to participate in the trial.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One shade universal compositeA 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 | Other | One shade universal composite |
| Nanohybrid resin compositeA conventional resin composite with multiple shades | Other | Nanohybrid resin composite |
Primary outcome
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)
2 secondary outcomes
Change in Marginal discoloration
Time frame: Baseline, 2 days, 3, 6 and 12 months
Change in surface texture
Time frame: Baseline, 2 days, 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- BackgroundAmeedee 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.
- Background: PubMed 16421996Bayne 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.
- BackgroundElzayat, 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.
- Background: PubMed 23479582Mourouzis 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.
- Background: PubMed 31095870Pereira 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.
- Background: PubMed 30166843Telang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed El Zoheiry, prof study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One shade universal composite and Nanohybrid resin composite in people with Anterior Teeth, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nayra Halim, Msc student (+201112417351, nayra.halim@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in shade matching (time frame: Baseline, 2 days, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05638373, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.