Class V RestorationsPhase 4NCT04129047
Shade Matching of Omnichroma (One Shade Universal Composite) Versus a Microhybrid Composite in Class V Restorations.
A Phase 4 study testing Omnichroma (one shade universal) composite by Tokuyama and A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA in people with Class V Restorations, run by Cairo University at 1 site in Egypt.
Trial summary
Background Resin composites are effective in restoring damaged teeth due to their good esthetics, high surface gloss, and clinically acceptable wear resistance1. One of the most challenging tasks a dentist has to confront in daily practice is matching the color of composite restorations used in anterior teeth2. Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Class V Restorations
- What is being tested?
- Omnichroma (one shade universal) composite by Tokuyama and A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2019to Jun 2020
- Phase
- Phase 4
- 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 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with carious class V lesions
- Non-carious cervical abfraction lesions
- Young adult Males or female
- Good oral hygiene
- 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.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Ahmed El Zohairy, Professor, +201227848002, aelzohairy@dentistry.cu.edu.eg
Maha El Baz, Ass. Professor, +201006611818, maha.elbaz@dentistry.cu.edu.eg
About this study
Official title: Shade Matching of Omnichroma (One Shade Universal Composite) Versus a Microhybrid Composite in Class V Restorations. A Randomized Clinical Trial
Background Resin composites are effective in restoring damaged teeth due to their good esthetics, high surface gloss, and clinically acceptable wear resistance1. One of the most challenging tasks a dentist has to confront in daily practice is matching the color of composite restorations used in anterior teeth2.
Problem The shade selection is carried out subjectively with a visual shade guide and generally under inadequate light conditions, which can lead to errors in color perception3. The presence of discrepancies between the classic shade guides and the actual shade of composite makes that task more difficult.4. Not only that, but there was also mismatch between composite shades and the proprietary shade guides included with the composite kits 5. A mock-up should be performed as a trial to assist in shade selection and ensure the predictability of the esthetic result in restorative treatment6.
Read more
Rationale Shade matching has been a time consuming procedure. Recommendations were made to make customized shade guides of the used composite material for more predictable results7. Manufacturers have been aiming at providing materials with a blending effect; taking on the color appearance from surrounding tooth structure 8. Introduction of Omnichroma by Tokuyama is aiming at eliminating the shade taking procedure by providing a single shade universal composite that is designed to blend with the surrounding tooth structure without the need for a shade matching procedure.
Aim The aim of this study is to evaluate the shade matching ability of a new single shade composite (Omnichroma; Tokuyama) compared to a conventional multiple shade microhybrid composite in the restoration of class V restorations using USPHS criteria
Read the detailed description
Background and rationale:
Research question:
In class V restorations will there be a difference in shade matching between Omnichroma (one shade) universal composite and a microhybrid (multiple shade) universal composite?
Statement of the problem:
The shade selection is carried out subjectively with a visual shade guide and generally under inadequate light conditions, which can lead to errors in color perception. The presence of discrepancies between the classic shade guides and the actual shade of composite makes that task more difficult. Not only that, but there was also mismatch between composite shades and the proprietary shade guides included with the composite kits. A mock-up should be performed as a trial to assist in shade selection and ensure the predictability of the esthetic result in restorative treatment.
Rationale for conducting the research:
Shade matching has been a time-consuming procedure. Recommendations were made to make customized shade guides of the used composite material for more predictable results. Manufacturers have been aiming at providing materials with a blending effect; taking on the color appearance from surrounding tooth structure. Introduction of Omnichroma by (Tokuyama Dental, Tokyo, Japan) is aiming at eliminating the shade taking procedure by providing a single shade universal composite that is designed to blend with the surrounding tooth structure without the need for a shade matching procedure.
Review of literature:
In 2004, Nahri compared the clinical efficacy of Z250 (3M, Saint Paul, MN, USA) with Z100 (3M, Saint Paul, MN, USA) in class III and class V restorations. A total of 148 restorations were placed by different dentists. The study used modified USPHS criteria to evaluate the restorations at baseline and for one year. Color match, along with marginal adaptation, discoloration, and anatomic form were evaluated using specified criteria. Baseline evaluation was done after one week from restoration placement. At baseline, 70% of the Z250 restorations were rated as Alpha regarding color-match compared to 62% of the Z100 restorations. It was concluded that there was no significant difference between the two materials and that both can be used in class V restorations.
A study by Sakrana compared between the clinical performance of Palfique Estelite,( Tokuyama Corp., Tokyo, Japan) resin composite and Palfique Toughwell (Tokuyama Corp., Tokyo, Japan) Resin Composite in anterior class V restorations. Both are minifilled composites with Palfique Estelite indicated for anterior restorations and Palfique Toughwell indicated for both anterior and posterior ones. Seventy eight class V cavities were restored using Palfique Estellite and eighty two were restored with Palfique Toughwell. Both groups were examined immediately after polishing (baseline), after 6 months, and after 1 year. Both showed 100% color match of rating Alpha (USPHS criteria) at baseline. At 6 months, 100 % of Palfique Estelite restorations were still rated as Alpha, while only 90% of the Palfique Toughwell restorations were still rated as Alpha. It was shown that Palfique Toughwell had more color change after one year. Only 70% were rated as Alpha regarding color match after one year. However, the difference was not significant and both materials prove to be reliable in class V restorations.
Another study by Paravina found color differences between same shades of 2 microhybrid composite when placed in specimens of different surrounding color or different size. They used specimens of 2 composite shades placed circumferentially. The outer ring was using the darker composite and the inner was the lighter. Palfique Estellite (Tokuyama, Tokyo, Japan) composite of shade C2 was used as the darker outer composite. Lighter shades (A2 and B2) of Palfique Estellite and Esthet-X (Dentsply/Caulk, Milford, DE) were used in the inner part. Multiple diameters (2,4,6) of the inner part were used. In addition to that, single composite specimens were prepared from the same shades for comparison. It was found that the same shades of composite appeared differently when placed in different diameters. Also, when there was less color difference between inner and outer disks, more color match is achieved. This led to a conclusion that composites can have a blending effect. This blending effect increased with decreased restoration size, decreased color difference, and translucency of the used composite.
Mourouzis compared the blending effect of three commercially available composites in vitro, microhybrid GC Gradia Direct Anterior (GC Corporation, Tokyo, Japan), microfilled Clearfil Majesty Esthetic (Kuraray Medical Inc., Tokyo, Japan), and nanofilled IPS Empress Direct (Ivoclar Vivadent, Shaan, Liechtenstein). The study was conducted on extracted teeth. Shade was taken for the teeth using a spectrophotometer. The teeth were sectioned vertically and restored using the three composite materials of the designated shade. The restorations were made using a prefabricated mold. The shade was taken afterwards and compared to that of intact teeth. Results were that all composite restorations had color differences with intact teeth. However, this difference was not visible by human eye and it was concluded that a color difference of ΔΕ<3.3 was considered clinically acceptable It was stated that the properties of the composite material have a drastic effect over esthetics. The Ivoclar group demonstrated the most color difference among the 3 groups.
McLaren et al introduced a technique using calibrated photography and photoshop for shade analysis. Digital photographs were taken in Raw format using polarizing filters and a gray card. The cross-polarizing filter is used for eliminating glare. The gray card is used to calibrate exposure in Adobe Camera Raw (which comes in adjunction with Adobe Photoshop to compensate for exposure differences between different camera-models. The authors provided recommended camera settings for standardization of images. L, A, and B values were calculated using digital color meter in photoshop and compared to those of shade tabs for shade selection. The authors claimed this technique to be effective, useful, and accurate in shade analysis.
In 2019, Paravina et al compared between color adjusting potential of 5 commercially available universal composites namely Omnichroma (Tokuyama Dental, Tokyo, Japan), Filtek Supreme Ultra (3M, Saint Paul, MN), TPH Spectra (Dentsply Caulk, Milford, DE), Herculite Ultra (Kerr Corporation, Orange, CA), and Tetric Evoceram (Ivoclar Vivadent, Amherst, NY) in vitro. Single and dual specimens were prepared. Single specimens were composed of the composite material alone and were compared to denture teeth. Dual specimens were composed of the restorative material placed in cavities prepared in acrylic teeth of different shades. Comparisons were made between denture teeth and single specimens and dual specimens. Comparisons were made visually and instrumentally. There was large color difference between single specimens and Denture teeth. However, dual specimens showed more color match. This was most pronounced in Omnichroma. It was concluded that Omnichroma had the most color adjusting potential. This means that it had a great color difference between single specimens and denture teeth. It also had the greatest color match in dual specimens.
6b. Explanation for choice of comparators:
Micro-hybrid composite was chosen as a comparator because it's considered a universal composite to be used in anterior and posterior restorations. It has high filler content along with good surface polish and color stability. Also according to a recent study, micro-hybrid composite showed excellent color match and color stability compared to nano-filled composite in five-years follow-up.
Interventions:
Patients attending at the Conservative and Esthetic Dentistry Department Clinic will be screened. Those who meet the study inclusion criteria will be recruited. They will be informed with the study and an informed consent will be signed if they approve.
First Periodontal treatment will be made and oral hygiene instructions will be enforced. Shade taking procedure will be done visually using customized composite shade tabs for more accuracy. Shade will be confirmed using cross-polarized photography and image analysis using a digital color meter (Adobe Photoshop).
Once the shade is confirmed, the operator will start rubber-dam isolation and cavity preparation using a round bur. Remaining caries will be excavated by a sharp excavator. A 1mm bevel will be prepared in enamel margins.
Selective enamel etching will be done and a universal adhesive will be applied to both enamel and dentin. After solvent evaporation, the bonding agent will be cured for 20 seconds. The operator will be blinded to the material to be used till the placement of the restoration to avoid bias. According to the concealed envelope, the tooth will be assigned to one of both treatment groups. Composite will be placed incrementally and light cured for 20 seconds using 3M Elipar DeepCure-S LED Curing Light (3M, Saint Paul, MN, USA)
Post curing will be done using Glycerin to decrease the oxygen inhibited layer. Finishing will be done using yellow and white finishing stones Intensiv (Intensiv SA, Montagnola, Switzerland). More finishing and polishing will be done using (Enhance and Pogo (Dentsply Sirona). Rubber-dam will be removed and patients will be recalled for baseline evaluation after one week to allow for rehydration.
The assessor will be blinded to both treatment groups. She will give the restorations a score using Modified USPHS score. Calibrated photographs will be taken using cross polarizing filters and a gray card for image analysis using Photoshop.
Recall appointments will be after 3 months and 6 months. Same evaluation will be made to assess color stability.
- Conditions
- Class V Restorations
- Being tested
- Omnichroma (one shade universal) composite by Tokuyama, A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnichroma (one shade universal) composite by TokuyamaDrug
Omnichroma is a single shade composite that is intended to have a color blending potential. It eliminates the shade matching procedures and makes it easier to avoid individual errors in shade matching in composite restorations.
A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USADrug
a multiple shade universal composite that needs prior shade selection procedure
| Study group | Role | What they receive |
|---|---|---|
| Omnichroma (one shade universal) composite by Tokuyama | Experimental | class V cavities will be made under isolation. Omnichroma (one shade universal) composite by Tokuyama will be placed according to guidelines. Receives: Drug: Omnichroma (one shade universal) composite by Tokuyama |
| A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA) | Active comparator | class V cavities will be made under isolation. A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA) will be placed according to guidelines. Receives: Drug: A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shade matching (visually and using image analysis)
To evaluate the shade matching ability of the newly introduced single shade composite compared to a conventional multiple shade micro hybrid composite. Assessment will be done visually using Modified USPHS Criteria and by image analysis. Image analysis will be done by comparing LAB values using Adobe Photoshop
Measured: Baseline after 1 week
Secondary outcomes (1)
Color stability (visually and using image analysis)
To evaluate the color stability of the newly introduced single shade composite compared to a conventional multiple shade micro hybrid composite. Assessment will be done visually using Modified USPHS Criteria and by image analysis. Image analysis will be done by comparing LAB values using Adobe Photoshop
Measured: Color stability between baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start20 Jul 2019
- Primary completionApr 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Class V RestorationsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mohamed Aly Aref, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129047
- Sponsor's protocol ID
- OPER 3-7-1
- Status last verified
- Oct 2019
- First submitted
- 12 Oct 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sakrana AA, Tanoue N, Kawasaki K, Matsumura H. One-year clinical evaluation of two composite materials used for anterior class V restorations. J Oral Rehabil. 2004 Oct;31(10):985-90. doi: 10.1111/j.1365-2842.2004.01333.x.
PubMed 15387839Bayne SC, Heymann HO, Swift EJ Jr. Update on dental composite restorations. J Am Dent Assoc. 1994 Jun;125(6):687-701. doi: 10.14219/jada.archive.1994.0113.
PubMed 8014334Ferracane JL. Resin composite--state of the art. Dent Mater. 2011 Jan;27(1):29-38. doi: 10.1016/j.dental.2010.10.020. Epub 2010 Nov 18.
PubMed 21093034Folwaczny M, Loher C, Mehl A, Kunzelmann KH, Hickel R. Class V lesions restored with four different tooth-colored materials--3-year results. Clin Oral Investig. 2001 Mar;5(1):31-9. doi: 10.1007/s007840000098.
PubMed 11355096Fondriest J. Shade matching in restorative dentistry: the science and strategies. Int J Periodontics Restorative Dent. 2003 Oct;23(5):467-79.
PubMed 14620121Hall NR, Kafalias MC. Composite colour matching: the development and evaluation of a restorative colour matching system. Aust Prosthodont J. 1991;5:47-52.
PubMed 1812939Kim HS, Um CM. Color differences between resin composites and shade guides. Quintessence Int. 1996 Aug;27(8):559-67.
PubMed 9161260Lee YK, Yu B, Lee SH, Cho MS, Lee CY, Lim HN. Shade compatibility of esthetic restorative materials--A review. Dent Mater. 2010 Dec;26(12):1119-26. doi: 10.1016/j.dental.2010.08.004. Epub 2010 Sep 15.
PubMed 20832851McLaren EA, Figueira J, Goldstein RE. A Technique Using Calibrated Photography and Photoshop for Accurate Shade Analysis and Communication. Compend Contin Educ Dent. 2017 Feb;38(2):106-113.
PubMed 28156124Mourouzis P, Koulaouzidou EA, Palaghias G, Helvatjoglu-Antoniades M. Color match of resin composites to intact tooth structure. J Appl Biomater Funct Mater. 2015 Oct 16;13(3):e259-65. doi: 10.5301/jabfm.5000228.
PubMed 26108430Narhi TO, Tanner J, Ostela I, Narva K, Nohrstrom T, Tirri T, Vallittu PK. Anterior Z250 resin composite restorations: one-year evaluation of clinical performance. Clin Oral Investig. 2003 Dec;7(4):241-3. doi: 10.1007/s00784-003-0231-6. Epub 2003 Sep 18.
PubMed 14505071Paravina 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, Kimura M, Powers JM. Color compatibility of resin composites of identical shade designation. Quintessence Int. 2006 Oct;37(9):713-9.
PubMed 17017633Pereira 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 31095870Ruschel VC, Martins MV, Bernardon JK, Maia HP. Color Match Between Composite Resin and Tooth Remnant in Class IV Restorations: A Case Series. Oper Dent. 2018 Sep/Oct;43(5):460-466. doi: 10.2341/17-132-S. Epub 2018 Mar 16.
PubMed 29547347
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shade Matching of Omnichroma (One Shade Universal Composite) Versus a Microhybrid Composite in Class V Restorations. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04129047
- Acronym / sponsor ID
- OPER 3-7-1
- Conditions
- Class V Restorations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jul 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 16 Oct 2019 (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.
Background Resin composites are effective in restoring damaged teeth due to their good esthetics, high surface gloss, and clinically acceptable wear resistance1. One of the most challenging tasks a dentist has to confront in daily practice is matching the color of composite restorations used in anterior teeth2.
Problem The shade selection is carried out subjectively with a visual shade guide and generally under inadequate light conditions, which can lead to errors in color perception3. The presence of discrepancies between the classic shade guides and the actual shade of composite makes that task more difficult.4. Not only that, but there was also mismatch between composite shades and the proprietary shade guides included with the composite kits 5. A mock-up should be performed as a trial to assist in shade selection and ensure the predictability of the esthetic result in restorative treatment6.
Rationale Shade matching has been a time consuming procedure. Recommendations were made to make customized shade guides of the used composite material for more predictable results7. Manufacturers have been aiming at providing materials with a blending effect; taking on the color appearance from surrounding tooth structure 8. Introduction of Omnichroma by Tokuyama is aiming at eliminating the shade taking procedure by providing a single shade universal composite that is designed to blend with the surrounding tooth structure without the need for a shade matching procedure.
Aim The aim of this study is to evaluate the shade matching ability of a new single shade composite (Omnichroma; Tokuyama) compared to a conventional multiple shade microhybrid composite in the restoration of class V restorations using USPHS criteria
Detailed description
Background and rationale:
Research question:
In class V restorations will there be a difference in shade matching between Omnichroma (one shade) universal composite and a microhybrid (multiple shade) universal composite?
Statement of the problem:
The shade selection is carried out subjectively with a visual shade guide and generally under inadequate light conditions, which can lead to errors in color perception. The presence of discrepancies between the classic shade guides and the actual shade of composite makes that task more difficult. Not only that, but there was also mismatch between composite shades and the proprietary shade guides included with the composite kits. A mock-up should be performed as a trial to assist in shade selection and ensure the predictability of the esthetic result in restorative treatment.
Rationale for conducting the research:
Shade matching has been a time-consuming procedure. Recommendations were made to make customized shade guides of the used composite material for more predictable results. Manufacturers have been aiming at providing materials with a blending effect; taking on the color appearance from surrounding tooth structure. Introduction of Omnichroma by (Tokuyama Dental, Tokyo, Japan) is aiming at eliminating the shade taking procedure by providing a single shade universal composite that is designed to blend with the surrounding tooth structure without the need for a shade matching procedure.
Review of literature:
In 2004, Nahri compared the clinical efficacy of Z250 (3M, Saint Paul, MN, USA) with Z100 (3M, Saint Paul, MN, USA) in class III and class V restorations. A total of 148 restorations were placed by different dentists. The study used modified USPHS criteria to evaluate the restorations at baseline and for one year. Color match, along with marginal adaptation, discoloration, and anatomic form were evaluated using specified criteria. Baseline evaluation was done after one week from restoration placement. At baseline, 70% of the Z250 restorations were rated as Alpha regarding color-match compared to 62% of the Z100 restorations. It was concluded that there was no significant difference between the two materials and that both can be used in class V restorations.
A study by Sakrana compared between the clinical performance of Palfique Estelite,( Tokuyama Corp., Tokyo, Japan) resin composite and Palfique Toughwell (Tokuyama Corp., Tokyo, Japan) Resin Composite in anterior class V restorations. Both are minifilled composites with Palfique Estelite indicated for anterior restorations and Palfique Toughwell indicated for both anterior and posterior ones. Seventy eight class V cavities were restored using Palfique Estellite and eighty two were restored with Palfique Toughwell. Both groups were examined immediately after polishing (baseline), after 6 months, and after 1 year. Both showed 100% color match of rating Alpha (USPHS criteria) at baseline. At 6 months, 100 % of Palfique Estelite restorations were still rated as Alpha, while only 90% of the Palfique Toughwell restorations were still rated as Alpha. It was shown that Palfique Toughwell had more color change after one year. Only 70% were rated as Alpha regarding color match after one year. However, the difference was not significant and both materials prove to be reliable in class V restorations.
Another study by Paravina found color differences between same shades of 2 microhybrid composite when placed in specimens of different surrounding color or different size. They used specimens of 2 composite shades placed circumferentially. The outer ring was using the darker composite and the inner was the lighter. Palfique Estellite (Tokuyama, Tokyo, Japan) composite of shade C2 was used as the darker outer composite. Lighter shades (A2 and B2) of Palfique Estellite and Esthet-X (Dentsply/Caulk, Milford, DE) were used in the inner part. Multiple diameters (2,4,6) of the inner part were used. In addition to that, single composite specimens were prepared from the same shades for comparison. It was found that the same shades of composite appeared differently when placed in different diameters. Also, when there was less color difference between inner and outer disks, more color match is achieved. This led to a conclusion that composites can have a blending effect. This blending effect increased with decreased restoration size, decreased color difference, and translucency of the used composite.
Mourouzis compared the blending effect of three commercially available composites in vitro, microhybrid GC Gradia Direct Anterior (GC Corporation, Tokyo, Japan), microfilled Clearfil Majesty Esthetic (Kuraray Medical Inc., Tokyo, Japan), and nanofilled IPS Empress Direct (Ivoclar Vivadent, Shaan, Liechtenstein). The study was conducted on extracted teeth. Shade was taken for the teeth using a spectrophotometer. The teeth were sectioned vertically and restored using the three composite materials of the designated shade. The restorations were made using a prefabricated mold. The shade was taken afterwards and compared to that of intact teeth. Results were that all composite restorations had color differences with intact teeth. However, this difference was not visible by human eye and it was concluded that a color difference of ΔΕ<3.3 was considered clinically acceptable It was stated that the properties of the composite material have a drastic effect over esthetics. The Ivoclar group demonstrated the most color difference among the 3 groups.
McLaren et al introduced a technique using calibrated photography and photoshop for shade analysis. Digital photographs were taken in Raw format using polarizing filters and a gray card. The cross-polarizing filter is used for eliminating glare. The gray card is used to calibrate exposure in Adobe Camera Raw (which comes in adjunction with Adobe Photoshop to compensate for exposure differences between different camera-models. The authors provided recommended camera settings for standardization of images. L, A, and B values were calculated using digital color meter in photoshop and compared to those of shade tabs for shade selection. The authors claimed this technique to be effective, useful, and accurate in shade analysis.
In 2019, Paravina et al compared between color adjusting potential of 5 commercially available universal composites namely Omnichroma (Tokuyama Dental, Tokyo, Japan), Filtek Supreme Ultra (3M, Saint Paul, MN), TPH Spectra (Dentsply Caulk, Milford, DE), Herculite Ultra (Kerr Corporation, Orange, CA), and Tetric Evoceram (Ivoclar Vivadent, Amherst, NY) in vitro. Single and dual specimens were prepared. Single specimens were composed of the composite material alone and were compared to denture teeth. Dual specimens were composed of the restorative material placed in cavities prepared in acrylic teeth of different shades. Comparisons were made between denture teeth and single specimens and dual specimens. Comparisons were made visually and instrumentally. There was large color difference between single specimens and Denture teeth. However, dual specimens showed more color match. This was most pronounced in Omnichroma. It was concluded that Omnichroma had the most color adjusting potential. This means that it had a great color difference between single specimens and denture teeth. It also had the greatest color match in dual specimens.
6b. Explanation for choice of comparators:
Micro-hybrid composite was chosen as a comparator because it's considered a universal composite to be used in anterior and posterior restorations. It has high filler content along with good surface polish and color stability. Also according to a recent study, micro-hybrid composite showed excellent color match and color stability compared to nano-filled composite in five-years follow-up.
Interventions:
Patients attending at the Conservative and Esthetic Dentistry Department Clinic will be screened. Those who meet the study inclusion criteria will be recruited. They will be informed with the study and an informed consent will be signed if they approve.
First Periodontal treatment will be made and oral hygiene instructions will be enforced. Shade taking procedure will be done visually using customized composite shade tabs for more accuracy. Shade will be confirmed using cross-polarized photography and image analysis using a digital color meter (Adobe Photoshop).
Once the shade is confirmed, the operator will start rubber-dam isolation and cavity preparation using a round bur. Remaining caries will be excavated by a sharp excavator. A 1mm bevel will be prepared in enamel margins.
Selective enamel etching will be done and a universal adhesive will be applied to both enamel and dentin. After solvent evaporation, the bonding agent will be cured for 20 seconds. The operator will be blinded to the material to be used till the placement of the restoration to avoid bias. According to the concealed envelope, the tooth will be assigned to one of both treatment groups. Composite will be placed incrementally and light cured for 20 seconds using 3M Elipar DeepCure-S LED Curing Light (3M, Saint Paul, MN, USA)
Post curing will be done using Glycerin to decrease the oxygen inhibited layer. Finishing will be done using yellow and white finishing stones Intensiv (Intensiv SA, Montagnola, Switzerland). More finishing and polishing will be done using (Enhance and Pogo (Dentsply Sirona). Rubber-dam will be removed and patients will be recalled for baseline evaluation after one week to allow for rehydration.
The assessor will be blinded to both treatment groups. She will give the restorations a score using Modified USPHS score. Calibrated photographs will be taken using cross polarizing filters and a gray card for image analysis using Photoshop.
Recall appointments will be after 3 months and 6 months. Same evaluation will be made to assess color stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omnichroma (one shade universal) composite by Tokuyama | Experimental | Drug: Omnichroma (one shade universal) composite by Tokuyamaclass V cavities will be made under isolation. Omnichroma (one shade universal) composite by Tokuyama will be placed according to guidelines. |
| A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA) | Active comparator | Drug: A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USAclass V cavities will be made under isolation. A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA) will be placed according to guidelines. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with carious class V lesions
- Non-carious cervical abfraction lesions
- Young adult Males or female
- Good oral hygiene
- 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 |
|---|---|---|
| Omnichroma (one shade universal) composite by TokuyamaOmnichroma is a single shade composite that is intended to have a color blending potential. It eliminates the shade matching procedures and makes it easier to avoid individual errors in shade matching in composite restorations. | Drug | Omnichroma (one shade universal) composite by Tokuyama |
| A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USAa multiple shade universal composite that needs prior shade selection procedure | Drug | A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA) |
Primary outcome
Shade matching (visually and using image analysis)
Time frame: Baseline after 1 week
To evaluate the shade matching ability of the newly introduced single shade composite compared to a conventional multiple shade micro hybrid composite. Assessment will be done visually using Modified USPHS Criteria and by image analysis. Image analysis will be done by comparing LAB values using Adobe Photoshop
1 secondary outcome
Color stability (visually and using image analysis)
Time frame: Color stability between baseline, 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Background: PubMed 15387839Sakrana AA, Tanoue N, Kawasaki K, Matsumura H. One-year clinical evaluation of two composite materials used for anterior class V restorations. J Oral Rehabil. 2004 Oct;31(10):985-90. doi: 10.1111/j.1365-2842.2004.01333.x.
- Background: PubMed 8014334Bayne SC, Heymann HO, Swift EJ Jr. Update on dental composite restorations. J Am Dent Assoc. 1994 Jun;125(6):687-701. doi: 10.14219/jada.archive.1994.0113.
- Background: PubMed 21093034Ferracane JL. Resin composite--state of the art. Dent Mater. 2011 Jan;27(1):29-38. doi: 10.1016/j.dental.2010.10.020. Epub 2010 Nov 18.
- Background: PubMed 11355096Folwaczny M, Loher C, Mehl A, Kunzelmann KH, Hickel R. Class V lesions restored with four different tooth-colored materials--3-year results. Clin Oral Investig. 2001 Mar;5(1):31-9. doi: 10.1007/s007840000098.
- Background: PubMed 14620121Fondriest J. Shade matching in restorative dentistry: the science and strategies. Int J Periodontics Restorative Dent. 2003 Oct;23(5):467-79.
- Background: PubMed 1812939Hall NR, Kafalias MC. Composite colour matching: the development and evaluation of a restorative colour matching system. Aust Prosthodont J. 1991;5:47-52.
- Background: PubMed 9161260Kim HS, Um CM. Color differences between resin composites and shade guides. Quintessence Int. 1996 Aug;27(8):559-67.
- Background: PubMed 20832851Lee YK, Yu B, Lee SH, Cho MS, Lee CY, Lim HN. Shade compatibility of esthetic restorative materials--A review. Dent Mater. 2010 Dec;26(12):1119-26. doi: 10.1016/j.dental.2010.08.004. Epub 2010 Sep 15.
- Background: PubMed 28156124McLaren EA, Figueira J, Goldstein RE. A Technique Using Calibrated Photography and Photoshop for Accurate Shade Analysis and Communication. Compend Contin Educ Dent. 2017 Feb;38(2):106-113.
- Background: PubMed 26108430Mourouzis P, Koulaouzidou EA, Palaghias G, Helvatjoglu-Antoniades M. Color match of resin composites to intact tooth structure. J Appl Biomater Funct Mater. 2015 Oct 16;13(3):e259-65. doi: 10.5301/jabfm.5000228.
- Background: PubMed 14505071Narhi TO, Tanner J, Ostela I, Narva K, Nohrstrom T, Tirri T, Vallittu PK. Anterior Z250 resin composite restorations: one-year evaluation of clinical performance. Clin Oral Investig. 2003 Dec;7(4):241-3. doi: 10.1007/s00784-003-0231-6. Epub 2003 Sep 18.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omnichroma (one shade universal) composite by Tokuyama and A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA in people with Class V Restorations, 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 5 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: status not confirmed, as of the sponsor's last update on 16 Oct 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shade matching (visually and using image analysis) (time frame: Baseline after 1 week). 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 NCT04129047, which also lists 17 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 16 Oct 2019.