Tooth DiscolorationNCT06543654
Evaluation of Template Assisted Monochromatic Structural Colored Versus Universal Multi-Shade Direct Composite Veneers
A study testing Omnichroma and Ceram. X Spectra in people with Tooth Discoloration, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study was to conduct a clinical trial utilizing a modified split-mouth, double-blinded, randomized strategy to clinically assess template assisted one shade structural colored versus universal multi-shade direct composite veneers Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- Omnichroma and Ceram. X Spectra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jul 2022to 9 Apr 2024
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- better dental hygiene
- discolored vital anterior teeth
Who cannot join
- Para functional activities
- Non-vital teeth
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to conduct a clinical trial utilizing a modified split-mouth, double-blinded, randomized strategy to clinically assess template assisted one shade structural colored versus universal multi-shade direct composite veneers
Read the detailed description
The superior mechanical qualities, superb aesthetics, and versatility of resin-based composites (RBCs) make them popular choices for direct restorative applications. Compared to their predecessors, nanocomposites have shown superior qualities since nanotechnology was introduced in the production of dental RBCs.
A restoration's aesthetic integration is mostly the result of its chromatic characteristics. Pigments included in the composition of the restorative material typically control the selective reflection of wavelengths to emulate the natural tooth. In order to better reflect the broad color range that characterizes real dentition, RBCs have more recently employed the phenomena of "structural color" .
Thanks to the novel property of resins, color differences between the tooth and the restoration are eliminated or balanced out as perceived color of a region moves toward the color of the surrounding area . Additionally, as opposed to multi-shade RBCs, single-shade RBCs eliminate the need to select between various resin shades, streamlining the color choosing procedure and cutting down on time lost during the clinical resin selection process. The Vita Classic Shade Guide's shades can all be matched with these materials.
- Conditions
- Tooth Discoloration
- Being tested
- Omnichroma, Ceram. X Spectra
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmnichromaOther
Each participants had two kinds of veneers
Ceram. X SpectraOther
Ceram. X Spectra
| Study group | Role | What they receive |
|---|---|---|
| Omnichroma | Experimental | Monochromatic structural colored composite Receives: Other: Omnichroma; Other: Ceram. X Spectra |
| Ceram. X Spectra | Experimental | Universal multi shade composite Receives: Other: Omnichroma; Other: Ceram. X Spectra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation was performed at baseline, six, nine, twelve, and eighteen months by two calibrated examiners using modified United States Public Health Service (USPHS) criteria
The perfect clinical scenario was represented by a score of 0, clinically acceptable by a score of 1, dubious by a score of 2, and clinically unsatisfactory by a score of 3 and 4.
Measured: eighteen months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start19 Jul 2022
- Primary completion5 Feb 2024
- Study completion9 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tooth DiscolorationStudies 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
- randomized controlled clinical study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abd El Ghany Mohammed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543654
- Sponsor's protocol ID
- Direct veneers
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kobayashi S, Nakajima M, Furusawa K, Tichy A, Hosaka K, Tagami J. Color adjustment potential of single-shade resin composite to various-shade human teeth: Effect of structural color phenomenon. Dent Mater J. 2021 Jul 31;40(4):1033-1040. doi: 10.4012/dmj.2020-364. Epub 2021 Apr 20.
PubMed 33883353Arai Y, Kurokawa H, Takamizawa T, Tsujimoto A, Saegusa M, Yokoyama M, Miyazaki M. Evaluation of structural coloration of experimental flowable resin composites. J Esthet Restor Dent. 2021 Mar;33(2):284-293. doi: 10.1111/jerd.12674. Epub 2020 Oct 24.
PubMed 33098228Furusawa K, Kobayashi S, Yamashita A, Tichy A, Hosaka K, Shimada Y, Nakajima M. Effect of filler load on structural coloration and color adjustment potential of resin composites. Dent Mater J. 2023 May 30;42(3):343-350. doi: 10.4012/dmj.2022-199. Epub 2023 Jan 28.
PubMed 36709985Kam Hepdeniz O, Temel UB. Clinical survival of No-prep indirect composite laminate veneers: a 7-year prospective case series study. BMC Oral Health. 2023 May 3;23(1):257. doi: 10.1186/s12903-023-02949-5.
PubMed 37138297Castro FLA, Durand LB. Influence of cavity wall thickness on the color adjustment potential of single-shade resin composites. J Am Dent Assoc. 2024 Jul;155(7):605-613. doi: 10.1016/j.adaj.2024.03.006. Epub 2024 May 31.
PubMed 38819355Miranda AO, Favoreto MW, Matos TP, Castro AS, Kunz P, Souza JL, Carvalho P, Reis A, Loguercio AD. Color Match of a Universal-shade Composite Resin for Restoration of Non-carious Cervical Lesions: An Equivalence Randomized Clinical Trial. Oper Dent. 2024 Jan 1;49(1):20-33. doi: 10.2341/23-021-C.
PubMed 38057996
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Template Assisted Monochromatic Structural Colored Versus Universal Multi-Shade Direct Composite Veneers
- ClinicalTrials.gov ID
- NCT06543654
- Acronym / sponsor ID
- Direct veneers
- Conditions
- Tooth Discoloration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to conduct a clinical trial utilizing a modified split-mouth, double-blinded, randomized strategy to clinically assess template assisted one shade structural colored versus universal multi-shade direct composite veneers
Detailed description
The superior mechanical qualities, superb aesthetics, and versatility of resin-based composites (RBCs) make them popular choices for direct restorative applications. Compared to their predecessors, nanocomposites have shown superior qualities since nanotechnology was introduced in the production of dental RBCs.
A restoration's aesthetic integration is mostly the result of its chromatic characteristics. Pigments included in the composition of the restorative material typically control the selective reflection of wavelengths to emulate the natural tooth. In order to better reflect the broad color range that characterizes real dentition, RBCs have more recently employed the phenomena of "structural color" .
Thanks to the novel property of resins, color differences between the tooth and the restoration are eliminated or balanced out as perceived color of a region moves toward the color of the surrounding area . Additionally, as opposed to multi-shade RBCs, single-shade RBCs eliminate the need to select between various resin shades, streamlining the color choosing procedure and cutting down on time lost during the clinical resin selection process. The Vita Classic Shade Guide's shades can all be matched with these materials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Omnichroma | Experimental | Other: Omnichroma, Other: Ceram. X SpectraMonochromatic structural colored composite |
| Ceram. X Spectra | Experimental | Other: Omnichroma, Other: Ceram. X SpectraUniversal multi shade composite |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- better dental hygiene
- discolored vital anterior teeth
Key exclusion criteria (2 listed)
- Para functional activities
- Non-vital teeth
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 |
|---|---|---|
| OmnichromaEach participants had two kinds of veneers | Other | Ceram. X Spectra, Omnichroma |
| Ceram. X SpectraCeram. X Spectra | Other | Ceram. X Spectra, Omnichroma |
Primary outcome
Clinical evaluation was performed at baseline, six, nine, twelve, and eighteen months by two calibrated examiners using modified United States Public Health Service (USPHS) criteria
Time frame: eighteen months
The perfect clinical scenario was represented by a score of 0, clinically acceptable by a score of 1, dubious by a score of 2, and clinically unsatisfactory by a score of 3 and 4.
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 9 Aug 2024.
- Results publication: PubMed 33883353Kobayashi S, Nakajima M, Furusawa K, Tichy A, Hosaka K, Tagami J. Color adjustment potential of single-shade resin composite to various-shade human teeth: Effect of structural color phenomenon. Dent Mater J. 2021 Jul 31;40(4):1033-1040. doi: 10.4012/dmj.2020-364. Epub 2021 Apr 20.
- Results publication: PubMed 33098228Arai Y, Kurokawa H, Takamizawa T, Tsujimoto A, Saegusa M, Yokoyama M, Miyazaki M. Evaluation of structural coloration of experimental flowable resin composites. J Esthet Restor Dent. 2021 Mar;33(2):284-293. doi: 10.1111/jerd.12674. Epub 2020 Oct 24.
- Results publication: PubMed 36709985Furusawa K, Kobayashi S, Yamashita A, Tichy A, Hosaka K, Shimada Y, Nakajima M. Effect of filler load on structural coloration and color adjustment potential of resin composites. Dent Mater J. 2023 May 30;42(3):343-350. doi: 10.4012/dmj.2022-199. Epub 2023 Jan 28.
- Results publication: PubMed 37138297Kam Hepdeniz O, Temel UB. Clinical survival of No-prep indirect composite laminate veneers: a 7-year prospective case series study. BMC Oral Health. 2023 May 3;23(1):257. doi: 10.1186/s12903-023-02949-5.
- Results publication: PubMed 38819355Castro FLA, Durand LB. Influence of cavity wall thickness on the color adjustment potential of single-shade resin composites. J Am Dent Assoc. 2024 Jul;155(7):605-613. doi: 10.1016/j.adaj.2024.03.006. Epub 2024 May 31.
- Results publication: PubMed 38057996Miranda AO, Favoreto MW, Matos TP, Castro AS, Kunz P, Souza JL, Carvalho P, Reis A, Loguercio AD. Color Match of a Universal-shade Composite Resin for Restoration of Non-carious Cervical Lesions: An Equivalence Randomized Clinical Trial. Oper Dent. 2024 Jan 1;49(1):20-33. doi: 10.2341/23-021-C.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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 Omnichroma and Ceram. X Spectra in people with Tooth Discoloration, run by Tanta 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 2 inclusion and 2 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Clinical evaluation was performed at baseline, six, nine, twelve, and eighteen months by two calibrated examiners using modified United States Public Health Service (USPHS) criteria (time frame: eighteen months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06543654, which also lists 6 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 9 Aug 2024.