Dental Caries (Disorder)NCT04960852
Color Match Assessment of a Single Shade Structurally Colored Universal Resin Composite
A study testing a single shade structurally colored universal resin composite in people with Dental Caries (Disorder), run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
Matching the color of resin composite utilized in anterior teeth is believed to be one of the most challenging tasks a dentist has to face in daily practice. The color of the teeth is primary influenced by dentin; on the other hand, enamel has a major influence on the color perception in terms of lightness. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Dental Caries (Disorder)
- What is being tested?
- a single shade structurally colored universal resin composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 6 Aug 2021
- 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with carious class V or Class III cavities
- Young adult Males or female
- patient with low or moderate caries risk index
- Co-operative patients approving to participate in the study
Who cannot join
- Patients with a compromised medical history
- Severe or active periodontal disease
- Severe medical complications
- Erosive lesions
- Lack of compliance and rampant caries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Color Match Assessment of a Single Shade Structurally Colored Universal Resin Composite: A Single Arm Clinical Trial
Matching the color of resin composite utilized in anterior teeth is believed to be one of the most challenging tasks a dentist has to face in daily practice. The color of the teeth is primary influenced by dentin; on the other hand, enamel has a major influence on the color perception in terms of lightness. In the layering concept, the missing dental tissues are substituted in increments with resin composite of the exact shade as the dental tissue. A translucent composite resin is applied over a more opaque composite resin to achieve a depth perception similar to that of the natural teeth. Which indicates that the visible color is the consequence of diffuse reflectance from the internal dentin or opaque material layer through the external translucent layer.
There are numerous elements that make the color matching problematic. These problems arise from the point that color matching rely on many different chromatic properties related to the teeth and resin composite; those include hue, chroma and value; translucency, opalescence and fluorescence; light diffusion and transmission; and luster and texture of the surface. To reach the ideal esthetics, restorative material should mimic the natural tooth in the previously mentioned properties, in addition of having a long time color stability.
Read more
Massive efforts were achieved over the years to improve the esthetic properties of dental resin composite restorative materials. Recently, a single shade structurally colored universal composite (Omnichroma, Tokuyama Dental) intended for use with most direct restorative clinical cases was introduced in the market. Its manufacturer claimed that it exhibits color change toward the color of the surrounding hard dental tissues. Thus, it has the advantages of improving the esthetic appearance of the restoration, decrease dependence on shade-matching procedures, decrease the number of shade guide tabs, and counteract for color mismatches to some degree.
Up till now no studies assessed the color match of Omnichroma resin composite in anterior teeth cavities clinically. Thus, the aim of this clinical trial was to investigate if the single shade structurally colored universal resin composite (OMNICHROMA) will modify its shade to match the tooth structure shade in anterior teeth cavities.
Read the detailed description
Participants' recruitment:
The patients will be selected from outpatient clinic of National Research Centre (NRC), Cairo; Egypt Eligible patients who agreed to participate in this trial will sign on written informed consents.
Clinical procedure
- Teeth color measurement Each patient first will receive scaling and polishing procedures to clean the teeth surfaces. A total of 45 anterior teeth cavities will be prepared. Before cavity preparation, shade determination will be performed with Vita Easyshade spectrophotometer. The probe tip will be positioned perpendicular and flushed onto the buccal surface of the tooth to get correct measurements.
- Cavities preparation Appropriate local dental anesthesia (Mepecaine-L) 1mg will be injected preoperatively unless declined by the patient. Treated teeth will be properly isolated and saliva ejector will be utilized.
Conservative cavities will be prepared with #330 carbide bur (FG, Dentsply Midwest®) fixed to a high speed hand piece with water coolant system. Cavity preparation will be limited to the removal of caries and the exact cavity form and size will be obtained after caries removal. Each bur will be discarded after 5 preparations.
A functional esthetic enamel bevel will be prepared using a fine grained finishing diamond rotary instrument on the facial surface, the bevel enables harmonious shade transition from composite to tooth substance.
- Application of the adhesive system and resin composite in the prepared cavities Enamel of the prepared cavities will be etched using UltraEtch (Ultradent, 40% phosphoric acid) for 30 seconds. After rinsing with water and air drying, the bonding agent will be applied according to the manufacturer's instructions to the cavity using a brush then air-thinned gently and light-cured for 20 seconds.
Omnichroma resin composite will be packed in the prepared cavities using a Teflon coated plastic instrument and the restoration will covered with celluloid strip to reduce the oxygen inhibition layer and to get a smooth surface, then light-cured for 40 sec. Excess material will be removed with scalpel. Finishing and polishing will be performed for the anatomical contouring and smoothing of the restorations surfaces using all grates of soflex discs, fine and Extra fine diamond burs, medium and fine rubber polishing points.
Color assessment Color match data will be recorded for the restoration after one week. The restorations will be gently dried with cotton and the color values of them will be recorded using the Vita Easyshade spectrophotometer.
The color changes (ΔE) will be calculated from the changes in CIE L, a, and b values (ΔL, Δa, Δb) as follows:
ΔE= [(ΔL)2 + (Δa)2 + (Δb)2]1/2 CIE Lab is expressed by the L coordinate representing color luminosity, varying from white to black, a and b coordinates representing the chromaticity of the color, with axes varying from green to red and blue to yellow, respectively. The mean of the values obtained will be calculated, and the L, a, and b parameters will be determined.
Visual assessment Visual assessment will be performed by two independent observers with normal color vision as checked by Ishiara test. To determine the color-matching between the restorations and the teeth. Color-matching visual scoring (VS) values will be expressed numerically as follows: 1: mismatch/totally unacceptable, 2: Poor-Match/hardly acceptable, 3: Good- Match/acceptable, 4: Close-Match/small-difference, and 5: Exact-Match/no-color-difference. All observers will be trained in color-matching and taught about the used grading system before the assessment.
- Conditions
- Dental Caries (Disorder)
- Being tested
- a single shade structurally colored universal resin composite
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a single shade structurally colored universal resin compositeOther
Omnichroma is a single shade composite that is claimed to have blending effect with the tooth color, thus eliminate shade matching procedures during restorative treatment
| Study group | Role | What they receive |
|---|---|---|
| a single shade structurally colored universal resin composite | Experimental | Cavities will be prepared. one shade universal composite (Omnichroma) a will be applied according to the manufacturer. Receives: Other: a single shade structurally colored universal resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
shade matching (digital analysis)
to assess the shade matching of the newly introduced OMNICHROMA resin composite to the tooth structure. Image analysis will be carried out by comparing LAB values using Easyshade spectrophotometer
Measured: after 1 week of restorations placement
Secondary outcomes (1)
shade match acceptance (visual assessment)
shade match acceptance will be evaluated by two observers Color-matching visual scoring (VS) values will be expressed numerically as follows: 1: mismatch/totally unacceptable, 2: Poor-Match/hardly acceptable, 3: Good- Match/acceptable, 4: Close-Match/small-difference, and 5: Exact-Match/no-color-difference.
Measured: after 1 week of restorations placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Apr 2021
- Primary completion6 Aug 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Caries (Disorder)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaymaa Mohamed Nagi, National Research Centre, Egypt
- Investigators
- Shaymaa M Nagi, pHD, Principal investigator, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960852
- Sponsor's protocol ID
- 3433042021
- Status last verified
- Aug 2021
- First submitted
- 2 Jul 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ragain JC, Johnston WM. Color acceptance of direct dental restorative materials by human observers. Color Res Appl. 2000;25(4):278-285. Riad MI, Gamal WM, Morsy AS. Color matching of a single shade structurally colored universal resin composite with the surrounding hard dental tissues. Egyptian Dental Journal; 2020, 66, 2721:2727. Kim BJ, Lee YK. Influence of the shade designation on the color difference between the same shade-designated resin composites by the brand. Dent Mater. 2009;25: 1148-54. Mohamed MA, Afutu R, Tran D, Dunn K, Ghanem J, Perry R and Kugel G. Shade-Matching Capacity of Omnichroma in Anterior Restorations. J Dental Sci 2020, 5(2): 000247. Kevin B. How to match any composite restoration shade: Tokuyama's OMNICHROMA Uses Smart Chromatic Technology to Match a Wider Range of Natural Teeth Colors. Dental Products Report 2019; 53(3): 36.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Match Assessment of a Single Shade Structurally Colored Universal Resin Composite: A Single Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT04960852
- Acronym / sponsor ID
- 3433042021
- Conditions
- Dental Caries (Disorder)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 14 Jul 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.
Matching the color of resin composite utilized in anterior teeth is believed to be one of the most challenging tasks a dentist has to face in daily practice. The color of the teeth is primary influenced by dentin; on the other hand, enamel has a major influence on the color perception in terms of lightness. In the layering concept, the missing dental tissues are substituted in increments with resin composite of the exact shade as the dental tissue. A translucent composite resin is applied over a more opaque composite resin to achieve a depth perception similar to that of the natural teeth. Which indicates that the visible color is the consequence of diffuse reflectance from the internal dentin or opaque material layer through the external translucent layer.
There are numerous elements that make the color matching problematic. These problems arise from the point that color matching rely on many different chromatic properties related to the teeth and resin composite; those include hue, chroma and value; translucency, opalescence and fluorescence; light diffusion and transmission; and luster and texture of the surface. To reach the ideal esthetics, restorative material should mimic the natural tooth in the previously mentioned properties, in addition of having a long time color stability.
Massive efforts were achieved over the years to improve the esthetic properties of dental resin composite restorative materials. Recently, a single shade structurally colored universal composite (Omnichroma, Tokuyama Dental) intended for use with most direct restorative clinical cases was introduced in the market. Its manufacturer claimed that it exhibits color change toward the color of the surrounding hard dental tissues. Thus, it has the advantages of improving the esthetic appearance of the restoration, decrease dependence on shade-matching procedures, decrease the number of shade guide tabs, and counteract for color mismatches to some degree.
Up till now no studies assessed the color match of Omnichroma resin composite in anterior teeth cavities clinically. Thus, the aim of this clinical trial was to investigate if the single shade structurally colored universal resin composite (OMNICHROMA) will modify its shade to match the tooth structure shade in anterior teeth cavities.
Detailed description
Participants' recruitment:
The patients will be selected from outpatient clinic of National Research Centre (NRC), Cairo; Egypt Eligible patients who agreed to participate in this trial will sign on written informed consents.
Clinical procedure
- Teeth color measurement Each patient first will receive scaling and polishing procedures to clean the teeth surfaces. A total of 45 anterior teeth cavities will be prepared. Before cavity preparation, shade determination will be performed with Vita Easyshade spectrophotometer. The probe tip will be positioned perpendicular and flushed onto the buccal surface of the tooth to get correct measurements.
- Cavities preparation Appropriate local dental anesthesia (Mepecaine-L) 1mg will be injected preoperatively unless declined by the patient. Treated teeth will be properly isolated and saliva ejector will be utilized.
Conservative cavities will be prepared with #330 carbide bur (FG, Dentsply Midwest®) fixed to a high speed hand piece with water coolant system. Cavity preparation will be limited to the removal of caries and the exact cavity form and size will be obtained after caries removal. Each bur will be discarded after 5 preparations.
A functional esthetic enamel bevel will be prepared using a fine grained finishing diamond rotary instrument on the facial surface, the bevel enables harmonious shade transition from composite to tooth substance.
- Application of the adhesive system and resin composite in the prepared cavities Enamel of the prepared cavities will be etched using UltraEtch (Ultradent, 40% phosphoric acid) for 30 seconds. After rinsing with water and air drying, the bonding agent will be applied according to the manufacturer's instructions to the cavity using a brush then air-thinned gently and light-cured for 20 seconds.
Omnichroma resin composite will be packed in the prepared cavities using a Teflon coated plastic instrument and the restoration will covered with celluloid strip to reduce the oxygen inhibition layer and to get a smooth surface, then light-cured for 40 sec. Excess material will be removed with scalpel. Finishing and polishing will be performed for the anatomical contouring and smoothing of the restorations surfaces using all grates of soflex discs, fine and Extra fine diamond burs, medium and fine rubber polishing points.
Color assessment Color match data will be recorded for the restoration after one week. The restorations will be gently dried with cotton and the color values of them will be recorded using the Vita Easyshade spectrophotometer.
The color changes (ΔE) will be calculated from the changes in CIE L, a, and b values (ΔL, Δa, Δb) as follows:
ΔE= [(ΔL)2 + (Δa)2 + (Δb)2]1/2 CIE Lab is expressed by the L coordinate representing color luminosity, varying from white to black, a and b coordinates representing the chromaticity of the color, with axes varying from green to red and blue to yellow, respectively. The mean of the values obtained will be calculated, and the L, a, and b parameters will be determined.
Visual assessment Visual assessment will be performed by two independent observers with normal color vision as checked by Ishiara test. To determine the color-matching between the restorations and the teeth. Color-matching visual scoring (VS) values will be expressed numerically as follows: 1: mismatch/totally unacceptable, 2: Poor-Match/hardly acceptable, 3: Good- Match/acceptable, 4: Close-Match/small-difference, and 5: Exact-Match/no-color-difference. All observers will be trained in color-matching and taught about the used grading system before the assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a single shade structurally colored universal resin composite | Experimental | Other: a single shade structurally colored universal resin compositeCavities will be prepared. one shade universal composite (Omnichroma) a will be applied according to the manufacturer. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with carious class V or Class III cavities
- Young adult Males or female
- patient with low or moderate caries risk index
- Co-operative patients approving to participate in the study
Key exclusion criteria (5 listed)
- Patients with a compromised medical history
- Severe or active periodontal disease
- Severe medical complications
- Erosive lesions
- Lack of compliance and rampant caries
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 |
|---|---|---|
| a single shade structurally colored universal resin compositeOmnichroma is a single shade composite that is claimed to have blending effect with the tooth color, thus eliminate shade matching procedures during restorative treatment | Other | a single shade structurally colored universal resin composite |
Primary outcome
shade matching (digital analysis)
Time frame: after 1 week of restorations placement
to assess the shade matching of the newly introduced OMNICHROMA resin composite to the tooth structure. Image analysis will be carried out by comparing LAB values using Easyshade spectrophotometer
1 secondary outcome
shade match acceptance (visual assessment)
Time frame: after 1 week of restorations placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- BackgroundRagain JC, Johnston WM. Color acceptance of direct dental restorative materials by human observers. Color Res Appl. 2000;25(4):278-285. Riad MI, Gamal WM, Morsy AS. Color matching of a single shade structurally colored universal resin composite with the surrounding hard dental tissues. Egyptian Dental Journal; 2020, 66, 2721:2727. Kim BJ, Lee YK. Influence of the shade designation on the color difference between the same shade-designated resin composites by the brand. Dent Mater. 2009;25: 1148-54. Mohamed MA, Afutu R, Tran D, Dunn K, Ghanem J, Perry R and Kugel G. Shade-Matching Capacity of Omnichroma in Anterior Restorations. J Dental Sci 2020, 5(2): 000247. Kevin B. How to match any composite restoration shade: Tokuyama's OMNICHROMA Uses Smart Chromatic Technology to Match a Wider Range of Natural Teeth Colors. Dental Products Report 2019; 53(3): 36.
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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.
Shaymaa M Nagi, pHD principal investigator
National Research Centre, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a single shade structurally colored universal resin composite in people with Dental Caries (Disorder), run by National Research Centre, Egypt 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 10 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
shade matching (digital analysis) (time frame: after 1 week of restorations placement). 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 NCT04960852, which also lists 1 linked publication.
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 10 Aug 2021.