Dental RestorationNCT04846101
Evaluation of Shade Matching Capacity of a Contemporary Composite Dental Material
A study testing OMNISHADE, MULTISHADE and Instrumental Shade Analysis in people with Dental Restoration, run by University of Jordan at 1 site in Jordan.
Trial summary
One of the main difficulties encountered in esthetic dentistry is the complexity associated with shade matching and layering technique to achieve optimal esthetic outcomes. To ensure an esthetic outcome, an imperceptible match of the color of the restorative material to that of the tooth is of utmost importance. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration
- What is being tested?
- OMNISHADE, MULTISHADE and Instrumental Shade Analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJordan
- Study dates
- Jun 2024to Sep 2026
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy patients
- Patients requiring anterior restorations
- Vital teeth
- Absence of periodontal or pulpal disease
- Patients willing to sign informed consent and returning for follow up
Who cannot join
- Patients with extensive caries and tooth loss
- Patient with periodontal disease
- Patients with poor oral hygiene and lack of motivation
- Patient with severe extrinsic or intrinsic discolorations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Shade Matching Capacity of a Single-shade Contemporary Resin Composite in Anterior Restorations
One of the main difficulties encountered in esthetic dentistry is the complexity associated with shade matching and layering technique to achieve optimal esthetic outcomes. To ensure an esthetic outcome, an imperceptible match of the color of the restorative material to that of the tooth is of utmost importance. Recently, a new shade matching composite that utilizes "smart chromatic technology", developed by Tokuyama was claimed to be able to capture the structural color of its surroundings teeth. Our main objective is to assess the blending capacity of OMNICHROMA composite material in anterior restorations of patients attending the Jordan University Hospital. Both visual and instrumental measurements will be performed and the differences between the shade of the composite resin and the tooth structure will be measured. In addition, multi chroma composite restorations will be placed for the purpose of comparison (control).
Read the detailed description
In the present study, the restorations will be placed under rubber dam isolation for moisture control. The cavities will be prepared according to the concepts of minimal invasive dentistry. Prior to placing the composite resin, the margins of the cavities will be finished using ultra fine grit diamond burs·and beveled in a 1-mm area. Deep cavities suspected to be near the pulp be lined with RMGI. Inclusion criteria: class Ill and Class IV carious lesions.
The enamel margins of the cavities will be acid etched for 60s with 37% phosphoric acid and then rinsed thoroughly with water spray. Afterwards, the dentin bonding system will be applied, left undisturbed for 20 s and then excess removed using an air syringe and light cured for 20s. The restorative composite material will be placed in incremental layers, adapted, each layer cured for 40s. After polymerization, the restorations will be finished under profuse water spray using diamonds, Sof-Lex finishing discs and polishers.
All restorations will be placed by one dentist (Pl). Written informed consent will be provided to all participants prior to starting the treatment
- Conditions
- Dental Restoration
- Being tested
- OMNISHADE, MULTISHADE, Instrumental Shade Analysis, Visual Shade Analysis, Patient satisfaction
- Keywords
- shade matching, dental material, blending effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMNISHADEOther
Anterior dental cavities (Class III, Class IV) will be restored with an omnishade composite material
MULTISHADEOther
Anterior dental cavities (Class III, Class IV) will be restored with conventional multishade composite material.
Instrumental Shade AnalysisDiagnostic test
Assessment will be performed by single operator using spectrophotometer (EASYSHADE) to detect color difference between tooth and restoration
Visual Shade AnalysisOther
Visual assessment will be performed by two calibrated specialists to evaluate shade matching between the tooth and restoration
Patient satisfactionOther
Patient satisfaction of the final shade match will be assessed on a visual analogue scale
| Study group | Role | What they receive |
|---|---|---|
| Anterior restorations using single shade OMNICHROMA composite | Experimental | Anterior class III and Class IV cavities will be restored using single shade composite material according to standard protocols of etching, bonding and composite placement. Receives: Other: OMNISHADE; Diagnostic Test: Instrumental Shade Analysis; Other: Visual Shade Analysis; Other: Patient satisfaction |
| Anterior restorations using multi-shade composite | Active comparator | Shade selection for the tooth will be performed prior to the placement of the restoration. Anterior class III and Class IV cavities will be restored using multi-shade composite material according to standard protocols of etching, bonding and composite placement. Receives: Other: MULTISHADE; Diagnostic Test: Instrumental Shade Analysis; Other: Visual Shade Analysis; Other: Patient satisfaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instrumental Color assessment
Color difference between restoration \& tooth will be assessed using VITASHADE spectrophotometer
Measured: 2 years
Visual color assessment
Color difference between restoration \& tooth will be evaluated by independent observers
Measured: 2 years
Secondary outcomes (1)
Patient satisfaction
Patient satisfaction of shade matching of the restoration will be evaluated using visual analogue scale
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study startJun 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2026 (estimated)
Why it stopped: Change of Trial components
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental RestorationStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Hattar, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846101
- Sponsor's protocol ID
- RCTomnishade
- Status last verified
- Jan 2024
- First submitted
- 11 Apr 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available for other researchers
Publications
Mikhail SS, Schricker SR, Azer SS, Brantley WA, Johnston WM. Optical characteristics of contemporary dental composite resin materials. J Dent. 2013 Sep;41(9):771-8. doi: 10.1016/j.jdent.2013.07.001. Epub 2013 Jul 12.
PubMed 23851132Paravina RD, Westland S, Kimura M, Powers JM, Imai FH. Color interaction of dental materials: blending effect of layered composites. Dent Mater. 2006 Oct;22(10):903-8. doi: 10.1016/j.dental.2005.11.018. Epub 2005 Dec 27.
PubMed 16378637Paravina RD, Westland S, Imai FH, Kimura M, Powers JM. Evaluation of blending effect of composites related to restoration size. Dent Mater. 2006 Apr;22(4):299-307. doi: 10.1016/j.dental.2005.04.022. Epub 2005 Aug 8.
PubMed 16085303Tanaka A, Nakajima M, Seki N, Foxton RM, Tagami J. The effect of tooth age on colour adjustment potential of resin composite restorations. J Dent. 2015 Feb;43(2):253-60. doi: 10.1016/j.jdent.2014.09.007. Epub 2014 Sep 19.
PubMed 25242100Pereira 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 31095870
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Shade Matching Capacity of a Single-shade Contemporary Resin Composite in Anterior Restorations
- ClinicalTrials.gov ID
- NCT04846101
- Acronym / sponsor ID
- RCTomnishade
- Conditions
- Dental Restoration
- Keywords
- shade matching, dental material, blending effect
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Change of Trial components
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 15 Apr 2021 (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 of the main difficulties encountered in esthetic dentistry is the complexity associated with shade matching and layering technique to achieve optimal esthetic outcomes. To ensure an esthetic outcome, an imperceptible match of the color of the restorative material to that of the tooth is of utmost importance. Recently, a new shade matching composite that utilizes "smart chromatic technology", developed by Tokuyama was claimed to be able to capture the structural color of its surroundings teeth. Our main objective is to assess the blending capacity of OMNICHROMA composite material in anterior restorations of patients attending the Jordan University Hospital. Both visual and instrumental measurements will be performed and the differences between the shade of the composite resin and the tooth structure will be measured. In addition, multi chroma composite restorations will be placed for the purpose of comparison (control).
Detailed description
In the present study, the restorations will be placed under rubber dam isolation for moisture control. The cavities will be prepared according to the concepts of minimal invasive dentistry. Prior to placing the composite resin, the margins of the cavities will be finished using ultra fine grit diamond burs·and beveled in a 1-mm area. Deep cavities suspected to be near the pulp be lined with RMGI. Inclusion criteria: class Ill and Class IV carious lesions.
The enamel margins of the cavities will be acid etched for 60s with 37% phosphoric acid and then rinsed thoroughly with water spray. Afterwards, the dentin bonding system will be applied, left undisturbed for 20 s and then excess removed using an air syringe and light cured for 20s. The restorative composite material will be placed in incremental layers, adapted, each layer cured for 40s. After polymerization, the restorations will be finished under profuse water spray using diamonds, Sof-Lex finishing discs and polishers.
All restorations will be placed by one dentist (Pl). Written informed consent will be provided to all participants prior to starting the treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior restorations using single shade OMNICHROMA composite | Experimental | Other: OMNISHADE, Diagnostic Test: Instrumental Shade Analysis, Other: Visual Shade Analysis, Other: Patient satisfactionAnterior class III and Class IV cavities will be restored using single shade composite material according to standard protocols of etching, bonding and composite placement. |
| Anterior restorations using multi-shade composite | Active comparator | Other: MULTISHADE, Diagnostic Test: Instrumental Shade Analysis, Other: Visual Shade Analysis, Other: Patient satisfactionShade selection for the tooth will be performed prior to the placement of the restoration. Anterior class III and Class IV cavities will be restored using multi-shade composite material according to standard protocols of etching, bonding and composite placement. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy patients
- Patients requiring anterior restorations
- Vital teeth
- Absence of periodontal or pulpal disease
- Patients willing to sign informed consent and returning for follow up
Key exclusion criteria (4 listed)
- Patients with extensive caries and tooth loss
- Patient with periodontal disease
- Patients with poor oral hygiene and lack of motivation
- Patient with severe extrinsic or intrinsic discolorations
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 |
|---|---|---|
| OMNISHADEAnterior dental cavities (Class III, Class IV) will be restored with an omnishade composite material | Other | Anterior restorations using single shade OMNICHROMA composite |
| MULTISHADEAnterior dental cavities (Class III, Class IV) will be restored with conventional multishade composite material. | Other | Anterior restorations using multi-shade composite |
| Instrumental Shade AnalysisAssessment will be performed by single operator using spectrophotometer (EASYSHADE) to detect color difference between tooth and restoration | Diagnostic test | Anterior restorations using multi-shade composite, Anterior restorations using single shade OMNICHROMA composite |
| Visual Shade AnalysisVisual assessment will be performed by two calibrated specialists to evaluate shade matching between the tooth and restoration | Other | Anterior restorations using multi-shade composite, Anterior restorations using single shade OMNICHROMA composite |
| Patient satisfactionPatient satisfaction of the final shade match will be assessed on a visual analogue scale | Other | Anterior restorations using multi-shade composite, Anterior restorations using single shade OMNICHROMA composite |
Primary outcome
Instrumental Color assessment
Time frame: 2 years
Color difference between restoration \& tooth will be assessed using VITASHADE spectrophotometer
Visual color assessment
Time frame: 2 years
Color difference between restoration \& tooth will be evaluated by independent observers
1 secondary outcome
Patient satisfaction
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 23851132Mikhail SS, Schricker SR, Azer SS, Brantley WA, Johnston WM. Optical characteristics of contemporary dental composite resin materials. J Dent. 2013 Sep;41(9):771-8. doi: 10.1016/j.jdent.2013.07.001. Epub 2013 Jul 12.
- Background: PubMed 16378637Paravina RD, Westland S, Kimura M, Powers JM, Imai FH. Color interaction of dental materials: blending effect of layered composites. Dent Mater. 2006 Oct;22(10):903-8. doi: 10.1016/j.dental.2005.11.018. Epub 2005 Dec 27.
- Background: PubMed 16085303Paravina RD, Westland S, Imai FH, Kimura M, Powers JM. Evaluation of blending effect of composites related to restoration size. Dent Mater. 2006 Apr;22(4):299-307. doi: 10.1016/j.dental.2005.04.022. Epub 2005 Aug 8.
- Background: PubMed 25242100Tanaka A, Nakajima M, Seki N, Foxton RM, Tagami J. The effect of tooth age on colour adjustment potential of resin composite restorations. J Dent. 2015 Feb;43(2):253-60. doi: 10.1016/j.jdent.2014.09.007. Epub 2014 Sep 19.
- 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.
- Individual participant dataSharing planned: Yes. Data will be made available for other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMNISHADE, MULTISHADE and Instrumental Shade Analysis in people with Dental Restoration, run by University of Jordan 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 5 inclusion and 4 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: paused, as of the sponsor's last update on 23 Jan 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Instrumental Color assessment (time frame: 2 years). The study lists 2 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 NCT04846101, which also lists 5 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 23 Jan 2024.