Composite ResinsNCT06884813
Clinical Evaluation of Color-Adjusting Composite Resin Following In-Office Dental Bleaching
A study testing Conventional nanohybrid multishade composite and hydrogen peroxide 40% in-Office Tooth Whitening System and Single shade nanohybrid composite and hydrogen peroxide 40% in-Office Tooth Whitening System in people with Composite Resins, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
One challenge faced by dental professionals is that, unlike natural tooth structure, composite restorations do not lighten when exposed to bleaching agents. As a result, functional restorations may need replacement after bleaching to match the newly whitened teeth. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Composite Resins
- What is being tested?
- Conventional nanohybrid multishade composite and hydrogen peroxide 40% in-Office Tooth Whitening System and Single shade nanohybrid composite and hydrogen peroxide 40% in-Office Tooth Whitening System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteJordan
- Study dates
- 10 Mar 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are willing to come back for follow-up appointments.
- Patients who are willing to sign an informed consent form.
- Patients with well documented clinical records and have at least two anterior restorations (both Omnichroma and conventional multi-shade nanohybrid composite.)
- Patients aged 18 years or older.
- Patients with good oral hygiene
- Patients with vital teeth.
- Patients who are willing to have the restorations replaced later if necessary if there is a color mismatch after bleaching treatment.
Who cannot join
- Individuals with severe bruxism or periodontal disease.
- Patients with non-vital teeth restored with composite fillings.
- Patients with severe tooth discoloration.
- Patients with fluorosis or tetracycline staining.
- Heavy smokers.
- Pregnant or nursing women.
- Patients undergoing orthodontic treatment.
- Patients with enamel or dentin deformations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site, 1 recruiting
- Recruiting
Jordan University of Science and Technology
Irbid, 21110
Zakereyya SM Albashaireh, PhD, 0791015505, albashai@just.edu.jo
About this study
Official title: Clinical Evaluation of a Single-Shade, Color-Adjusting Composite Resin Following In-Office Dental Bleaching: A Randomized Clinical Trial
One challenge faced by dental professionals is that, unlike natural tooth structure, composite restorations do not lighten when exposed to bleaching agents. As a result, functional restorations may need replacement after bleaching to match the newly whitened teeth. However, replacing a composite restoration can lead to unnecessary removal of tooth structure, potentially weakening the tooth and increasing its susceptibility to further iatrogenic damage. This study will investigate the ability of Omnichroma restorations to shade-match tooth structure after bleaching.
The null hypotheses will be:
- Single-shade RBC will not exhibit similar shade and optical behavior to conventional RBC across all anterior restorations following bleaching.
- Patient satisfaction regarding color blending between the restoration and tooth structure will not differ according to the type of material used.
- Dentist satisfaction regarding color blending between the restoration and tooth structure will not differ according to the type of material used.
Read the detailed description
Selecting the proper shade for a restoration is of vital importance for achieving optimal aesthetic results. However, shade selection can be time-consuming, somewhat subjective, and heavily reliant on the clinician's visual judgement.
This study will explore the ability of Omnichroma restorations to shade match tooth structure after bleaching. Patients visiting the JUST dental clinics who have at least two anterior restorations (one Omnichroma restoration and one multi-shade nanohybrid composite restoration) will be recruited for this study. The calculated sample size for the study is 240 teeth.
The shade and the L*a*b* scores will be recorded using spectrophotometer prior to bleaching and after bleaching. Two blinded, calibrated dentists will independently evaluate the resulting shade outcomes and assess the degree of color match between the restorations and the adjacent teeth after bleaching. This assessment will be categorized as either match or no match. The patient's satisfaction will also be recorded two weeks after bleaching.
- Conditions
- Composite Resins
- Being tested
- Conventional nanohybrid multishade composite and hydrogen peroxide 40% in-Office Tooth Whitening System, Single shade nanohybrid composite and hydrogen peroxide 40% in-Office Tooth Whitening System
- Keywords
- Single-shade composite, Bleaching, clinical trial, Shade matching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional nanohybrid multishade composite and hydrogen peroxide 40% in-Office Tooth Whitening SystemDrug
Also called Conventional resin based composite (RBC) and Hydrogen perioxide 40%
Teeth restored with conventional multi shade nanohybrid Resin Based Composite (RBC) Filtek Z350Xt (3M ESPE, San Paul, MN, USA) subjected to bleaching using Opalescence Boost 40% In-Office Tooth Whitening System (Ultradent, Utah, USA)
Single shade nanohybrid composite and hydrogen peroxide 40% in-Office Tooth Whitening SystemDrug
Also called RBC with color adjustment potential (CAP) and Hydrogen perioxide 40%
Teeth restored with One-shade Resin Based Composite (Omnichroma, Tokuyama Dental, Tokio, Japan) subjected to bleaching using Opalescence Boost 40% In-Office Tooth Whitening System (Ultradent, Utah, USA)
| Study group | Role | What they receive |
|---|---|---|
| Control group (Conventional RBC) | Experimental | In office bleaching for teeth restored using conventional multishade nanohybrid resin based composite (RBC). Receives: Drug: Conventional nanohybrid multishade composite and hydrogen peroxide 40% in-Office Tooth Whitening System |
| Test group (RBC with CAP) | Experimental | In office bleaching for teeth restored using Omnichroma (single shade) composite with color adjustment postential (CAP). Receives: Drug: Single shade nanohybrid composite and hydrogen peroxide 40% in-Office Tooth Whitening System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color measurements using digital spectrophotometer VITA Easyshade V.
The colour measurements will be taken at first session for each tooth in specific points as follow:
One reading from middle part of tooth Three readings at three points around the restoration and 1 mm away from its margins.
To give a chance for tooth rehydration and final color optimization, a new reading will be obtained from the middle portion of the restoration after one week.
The color difference (∆E00) between the tooth structure around the restoration and the restoration itself will be calculated.
The color difference (∆E00) between the tooth and restoration will be compared between the control and test groups.
The final ΔE00 value itself has no physical unit. It is just a numerical representation of color difference.
Measured: One year
Subjective or Patient satisfaction
Patient satisfaction regarding color blending between the restoration and tooth surface will be recorded after one week using visual analogue scale (VAS).
The scale is a horizontal line with 10 digits, where 0 (on the right) represents total dissatisfaction with color blending between the tooth and restoration, and 10 (on the left) indicates complete satisfaction.
Patients will mark their satisfaction with the color matching and blending of the restoration on the VAS.
Measurements will be categorized as follows:
Poor: VAS values from 0 to 5 Good: VAS values from 5.1 to 10
Measured: One year
Objective or dentists satisfaction
Photographs of the restored teeth will be taken under a standardized setup using a Canon 250D DSLR camera, a Sigma 105 mm macro lens, and a Meike MK-14EXT TTL macro ring flash.
The images will be evaluated by two calibrated dentists who are blinded to the restoration material. Blending with the tooth surface will be assessed using VAS, with the assessors marking their evaluation on the scale.
Measurements will be divided according following criteria:
Poor: VAS values ranging from 0-5. Good :VAS values ranging from 5.1-10.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start10 Mar 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Composite ResinsStudies of the same condition, open and under way.
- 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
- Model description
- Split mouth study design, patients will be assigned to two different treatment protocols.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884813
- Sponsor's protocol ID
- 20250033
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Villarroel M, Fahl N, De Sousa AM, De Oliveira OB Jr. Direct esthetic restorations based on translucency and opacity of composite resins. J Esthet Restor Dent. 2011 Apr;23(2):73-87. doi: 10.1111/j.1708-8240.2010.00392.x. Epub 2011 Feb 25.
PubMed 21477031Hafez R, Ahmed D, Yousry M, El-Badrawy W, El-Mowafy O. Effect of in-office bleaching on color and surface roughness of composite restoratives. Eur J Dent. 2010 Apr;4(2):118-27.
PubMed 20396441Forabosco E, Consolo U, Mazzitelli C, Kaleci S, Generali L, Checchi V. Effect of bleaching on the color match of single-shade resin composites. J Oral Sci. 2023 Oct 1;65(4):232-236. doi: 10.2334/josnusd.23-0159. Epub 2023 Aug 3.
PubMed 37532526AlHabdan A, AlShamrani A, AlHumaidan R, AlFehaid A, Eisa S. Color Matching of Universal Shade Resin-Based Composite with Natural Teeth and Its Stability before and after In-Office Bleaching. Int J Biomater. 2022 Oct 26;2022:8420890. doi: 10.1155/2022/8420890. eCollection 2022.
PubMed 36341131
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Single-Shade, Color-Adjusting Composite Resin Following In-Office Dental Bleaching: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06884813
- Acronym / sponsor ID
- 20250033
- Conditions
- Composite Resins
- Keywords
- Single-shade composite, Bleaching, clinical trial, Shade matching
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 19 Mar 2025 (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.
One challenge faced by dental professionals is that, unlike natural tooth structure, composite restorations do not lighten when exposed to bleaching agents. As a result, functional restorations may need replacement after bleaching to match the newly whitened teeth. However, replacing a composite restoration can lead to unnecessary removal of tooth structure, potentially weakening the tooth and increasing its susceptibility to further iatrogenic damage. This study will investigate the ability of Omnichroma restorations to shade-match tooth structure after bleaching.
The null hypotheses will be:
- Single-shade RBC will not exhibit similar shade and optical behavior to conventional RBC across all anterior restorations following bleaching.
- Patient satisfaction regarding color blending between the restoration and tooth structure will not differ according to the type of material used.
- Dentist satisfaction regarding color blending between the restoration and tooth structure will not differ according to the type of material used.
Detailed description
Selecting the proper shade for a restoration is of vital importance for achieving optimal aesthetic results. However, shade selection can be time-consuming, somewhat subjective, and heavily reliant on the clinician's visual judgement.
This study will explore the ability of Omnichroma restorations to shade match tooth structure after bleaching. Patients visiting the JUST dental clinics who have at least two anterior restorations (one Omnichroma restoration and one multi-shade nanohybrid composite restoration) will be recruited for this study. The calculated sample size for the study is 240 teeth.
The shade and the L*a*b* scores will be recorded using spectrophotometer prior to bleaching and after bleaching. Two blinded, calibrated dentists will independently evaluate the resulting shade outcomes and assess the degree of color match between the restorations and the adjacent teeth after bleaching. This assessment will be categorized as either match or no match. The patient's satisfaction will also be recorded two weeks after bleaching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth study design, patients will be assigned to two different treatment protocols.
| Arm | Type | Receives |
|---|---|---|
| Control group (Conventional RBC) | Experimental | Drug: Conventional nanohybrid multishade composite and hydrogen peroxide 40% in-Office Tooth Whitening SystemIn office bleaching for teeth restored using conventional multishade nanohybrid resin based composite (RBC). |
| Test group (RBC with CAP) | Experimental | Drug: Single shade nanohybrid composite and hydrogen peroxide 40% in-Office Tooth Whitening SystemIn office bleaching for teeth restored using Omnichroma (single shade) composite with color adjustment postential (CAP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who are willing to come back for follow-up appointments.
- Patients who are willing to sign an informed consent form.
- Patients with well documented clinical records and have at least two anterior restorations (both Omnichroma and conventional multi-shade nanohybrid composite.)
- Patients aged 18 years or older.
- Patients with good oral hygiene
Key exclusion criteria (8 listed)
- Individuals with severe bruxism or periodontal disease.
- Patients with non-vital teeth restored with composite fillings.
- Patients with severe tooth discoloration.
- Patients with fluorosis or tetracycline staining.
- Heavy smokers.
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 |
|---|---|---|
| Conventional nanohybrid multishade composite and hydrogen peroxide 40% in-Office Tooth Whitening SystemAlso: Conventional resin based composite (RBC) and Hydrogen perioxide 40%Teeth restored with conventional multi shade nanohybrid Resin Based Composite (RBC) Filtek Z350Xt (3M ESPE, San Paul, MN, USA) subjected to bleaching using Opalescence Boost 40% In-Office Tooth Whitening System (Ultradent, Utah, USA) | Drug | Control group (Conventional RBC) |
| Single shade nanohybrid composite and hydrogen peroxide 40% in-Office Tooth Whitening SystemAlso: RBC with color adjustment potential (CAP) and Hydrogen perioxide 40%Teeth restored with One-shade Resin Based Composite (Omnichroma, Tokuyama Dental, Tokio, Japan) subjected to bleaching using Opalescence Boost 40% In-Office Tooth Whitening System (Ultradent, Utah, USA) | Drug | Test group (RBC with CAP) |
Primary outcome
Color measurements using digital spectrophotometer VITA Easyshade V.
Time frame: One year
The colour measurements will be taken at first session for each tooth in specific points as follow: One reading from middle part of tooth Three readings at three points around the restoration and 1 mm away from its margins. To give a chance for tooth rehydration and final color optimization, a new reading will be obtained from the middle portion of the restoration after one week. The color difference (∆E00) between the tooth structure around the restoration and the restoration itself will be calculated. The color difference (∆E00) between the tooth and restoration will be compared between the control and test groups. The final ΔE00 value itself has no physical unit. It is just a numerical representation of color difference.
Subjective or Patient satisfaction
Time frame: One year
Patient satisfaction regarding color blending between the restoration and tooth surface will be recorded after one week using visual analogue scale (VAS). The scale is a horizontal line with 10 digits, where 0 (on the right) represents total dissatisfaction with color blending between the tooth and restoration, and 10 (on the left) indicates complete satisfaction. Patients will mark their satisfaction with the color matching and blending of the restoration on the VAS. Measurements will be categorized as follows: Poor: VAS values from 0 to 5 Good: VAS values from 5.1 to 10
Objective or dentists satisfaction
Time frame: One year
Photographs of the restored teeth will be taken under a standardized setup using a Canon 250D DSLR camera, a Sigma 105 mm macro lens, and a Meike MK-14EXT TTL macro ring flash. The images will be evaluated by two calibrated dentists who are blinded to the restoration material. Blending with the tooth surface will be assessed using VAS, with the assessors marking their evaluation on the scale. Measurements will be divided according following criteria: Poor: VAS values ranging from 0-5. Good :VAS values ranging from 5.1-10.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Background: PubMed 21477031Villarroel M, Fahl N, De Sousa AM, De Oliveira OB Jr. Direct esthetic restorations based on translucency and opacity of composite resins. J Esthet Restor Dent. 2011 Apr;23(2):73-87. doi: 10.1111/j.1708-8240.2010.00392.x. Epub 2011 Feb 25.
- Background: PubMed 20396441Hafez R, Ahmed D, Yousry M, El-Badrawy W, El-Mowafy O. Effect of in-office bleaching on color and surface roughness of composite restoratives. Eur J Dent. 2010 Apr;4(2):118-27.
- Background: PubMed 37532526Forabosco E, Consolo U, Mazzitelli C, Kaleci S, Generali L, Checchi V. Effect of bleaching on the color match of single-shade resin composites. J Oral Sci. 2023 Oct 1;65(4):232-236. doi: 10.2334/josnusd.23-0159. Epub 2023 Aug 3.
- Background: PubMed 36341131AlHabdan A, AlShamrani A, AlHumaidan R, AlFehaid A, Eisa S. Color Matching of Universal Shade Resin-Based Composite with Natural Teeth and Its Stability before and after In-Office Bleaching. Int J Biomater. 2022 Oct 26;2022:8420890. doi: 10.1155/2022/8420890. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Composite Resins
Not yet recruiting
Clinical and 3D Evaluation of Injectable Versus Conventional Composite in Class V Restorations
Class V Dental Restorations
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
Enrolling by invitation
Clinical Evaluation of 3D-Printed Versus Direct Composite Restorations in Class II Cavities
3D-Printed, Direct Composite
Active, not recruiting
Two-year Clinical Performance of Ion-releasing and Conventional Bulk-fill Resin Composite Restorative Systems.
Class I Dental Caries
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional nanohybrid multishade composite and hydrogen peroxide 40% in-Office Tooth Whitening System and Single shade nanohybrid composite and hydrogen peroxide 40% in-Office Tooth Whitening System in people with Composite Resins, run by King Abdullah University Hospital at 1 site in Jordan.
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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 24 Mar 2025. 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 Jordan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zakereyya SM Albashaireh, Ph.D (0791015505, albashai@just.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color measurements using digital spectrophotometer VITA Easyshade V. (time frame: One year). The study lists 3 primary outcomes in all. 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 NCT06884813, which also lists 4 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 24 Mar 2025.