Tooth DiscolorationNCT06510400
Clinical Evaluation of Color Stability of Direct Composite Resin Veneers in Vital Anterior Teeth
A study testing OMNICHROMA and Ceram. x spectra in people with Tooth Discoloration, run by Tanta University at 1 site in Egypt.
Trial summary
Assess color stability of direct veneers over an 18-month recall periods 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
- have good hygiene.
- No medical diseases
- discolored vital anterior teeth
Who cannot join
- para functional activities.
- non vital teeth.
- severe intrinsic discoloration.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Restorative Department, Faculty of Dentistry, Tanta University
Tanta, 31527
About this study
Assess color stability of direct veneers over an 18-month recall periods
Read the detailed description
In today's restorative dentistry, aesthetics has become essential. The primary determinants of the aesthetics of natural teeth are color and form. The significance of color in dental science has greatly increased during the past few decades.
Techniques to restore teeth to their natural appearance have been developed in direct response to patient demand for cosmetic dental procedures. In contemporary cosmetic dentistry, discolorations are often seen as an aesthetic concern.
In order to correct cosmetic flaws in color and form, direct laminate veneers entail the creative application of resin composite material to the tooth surfaces. Because they may be completed chairside, are readily repaired, and have abrasion rates that are similar to those of real teeth, they are viewed as competitors to ceramic veneers.
With direct resin composite veneers, color stability is thought to be a common clinical issue that reduces the aesthetic result over an extended period of clinical service. The capacity of any dental material to retain its original color is known as color stability.
The clinical restoration process is streamlined with the introduction of universal composites, which also considerably reduce chair-side time and simplify the color matching such as OMNICHROMA.
- 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
supra nano filled composite
Ceram. x spectraOther
nano hybrid composite resin
| Study group | Role | What they receive |
|---|---|---|
| OMNICHROMA | Experimental | single shade composite was placed to prepared tooth enamel via U veneer template technique Receives: Other: OMNICHROMA; Other: Ceram. x spectra |
| Ceram. x spectra | Experimental | multi shade composite was placed to prepared tooth enamel via U veneer template technique Receives: Other: OMNICHROMA; Other: Ceram. x spectra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color stability evaluation
Two calibrated evaluators who were not engaged in the insertion of veneer restorations used VITA Easyshade V to measure the color (ΔE). The device was calibrated before reading.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 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 (10)Papers the sponsor has linked to this study.
- Other trials for Tooth DiscolorationStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT06510400
- Sponsor's protocol ID
- Color Stability
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hirata R, Hilgert LA, Sampaio CS, de Andrade OS, Melo G, Ritter AV. Quo vadis, esthetic dentistry? Part II: Composite resin overtreatment and social media appeal. J Esthet Restor Dent. 2024 Jan;36(1):32-36. doi: 10.1111/jerd.13162. Epub 2023 Dec 23.
PubMed 38142060de Abreu JLB, Sampaio CS, Benalcazar Jalkh EB, Hirata R. Analysis of the color matching of universal resin composites in anterior restorations. J Esthet Restor Dent. 2021 Mar;33(2):269-276. doi: 10.1111/jerd.12659. Epub 2020 Sep 29.
PubMed 32989879Fahl N Jr,, Ritter AV. Composite veneers: The direct-indirect technique revisited. J Esthet Restor Dent. 2021 Jan;33(1):7-19. doi: 10.1111/jerd.12696. Epub 2020 Dec 18.
PubMed 33336852Kam 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 37138297Zhao X, Zanetti F, Wang L, Pan J, Majeed S, Malmstrom H, Peitsch MC, Hoeng J, Ren Y. Effects of different discoloration challenges and whitening treatments on dental hard tissues and composite resin restorations. J Dent. 2019 Oct;89:103182. doi: 10.1016/j.jdent.2019.103182. Epub 2019 Aug 17.
PubMed 31430508Miranda 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 38057996Huang M, Wang Y, Sun Y, Zhou Y, Liu Y, Ye H. The accuracies of three intraoral scanners with regard to shade determination: An in vitro study. J Prosthodont. 2023 Jun;32(5):111-117. doi: 10.1111/jopr.13571. Epub 2022 Aug 10.
PubMed 35848886Sabatini C. Color Stability Behavior of Methacrylate-based Resin Composites Polymerized with Light-emitting Diodes and Quartz-Tungsten-Halogen. Oper Dent. 2015 May-Jun;40(3):271-81. doi: 10.2341/14-080-L. Epub 2014 Oct 2.
PubMed 25275958El-Rashidy AA, Abdelraouf RM, Habib NA. Effect of two artificial aging protocols on color and gloss of single-shade versus multi-shade resin composites. BMC Oral Health. 2022 Aug 1;22(1):321. doi: 10.1186/s12903-022-02351-7.
PubMed 35915423Mahrous AI, Salama AA, Shabaan AA, Abdou A, Radwan MM. Color stability of two different resin matrix ceramics: randomized clinical trial. BMC Oral Health. 2023 Sep 14;23(1):665. doi: 10.1186/s12903-023-03364-6.
PubMed 37710194
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Color Stability of Direct Composite Resin Veneers in Vital Anterior Teeth
- ClinicalTrials.gov ID
- NCT06510400
- Acronym / sponsor ID
- Color Stability
- 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
- 19 Jul 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.
Assess color stability of direct veneers over an 18-month recall periods
Detailed description
In today's restorative dentistry, aesthetics has become essential. The primary determinants of the aesthetics of natural teeth are color and form. The significance of color in dental science has greatly increased during the past few decades.
Techniques to restore teeth to their natural appearance have been developed in direct response to patient demand for cosmetic dental procedures. In contemporary cosmetic dentistry, discolorations are often seen as an aesthetic concern.
In order to correct cosmetic flaws in color and form, direct laminate veneers entail the creative application of resin composite material to the tooth surfaces. Because they may be completed chairside, are readily repaired, and have abrasion rates that are similar to those of real teeth, they are viewed as competitors to ceramic veneers.
With direct resin composite veneers, color stability is thought to be a common clinical issue that reduces the aesthetic result over an extended period of clinical service. The capacity of any dental material to retain its original color is known as color stability.
The clinical restoration process is streamlined with the introduction of universal composites, which also considerably reduce chair-side time and simplify the color matching such as OMNICHROMA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMNICHROMA | Experimental | Other: OMNICHROMA, Other: Ceram. x spectrasingle shade composite was placed to prepared tooth enamel via U veneer template technique |
| Ceram. x spectra | Experimental | Other: OMNICHROMA, Other: Ceram. x spectramulti shade composite was placed to prepared tooth enamel via U veneer template technique |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- have good hygiene.
- No medical diseases
- discolored vital anterior teeth
Key exclusion criteria (3 listed)
- para functional activities.
- non vital teeth.
- severe intrinsic discoloration.
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 |
|---|---|---|
| OMNICHROMAsupra nano filled composite | Other | Ceram. x spectra, OMNICHROMA |
| Ceram. x spectranano hybrid composite resin | Other | Ceram. x spectra, OMNICHROMA |
Primary outcome
Color stability evaluation
Time frame: 18 months
Two calibrated evaluators who were not engaged in the insertion of veneer restorations used VITA Easyshade V to measure the color (ΔE). The device was calibrated before reading.
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 24 Jul 2024.
- Background: PubMed 38142060Hirata R, Hilgert LA, Sampaio CS, de Andrade OS, Melo G, Ritter AV. Quo vadis, esthetic dentistry? Part II: Composite resin overtreatment and social media appeal. J Esthet Restor Dent. 2024 Jan;36(1):32-36. doi: 10.1111/jerd.13162. Epub 2023 Dec 23.
- Background: PubMed 32989879de Abreu JLB, Sampaio CS, Benalcazar Jalkh EB, Hirata R. Analysis of the color matching of universal resin composites in anterior restorations. J Esthet Restor Dent. 2021 Mar;33(2):269-276. doi: 10.1111/jerd.12659. Epub 2020 Sep 29.
- Background: PubMed 33336852Fahl N Jr,, Ritter AV. Composite veneers: The direct-indirect technique revisited. J Esthet Restor Dent. 2021 Jan;33(1):7-19. doi: 10.1111/jerd.12696. Epub 2020 Dec 18.
- Background: 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.
- Background: PubMed 31430508Zhao X, Zanetti F, Wang L, Pan J, Majeed S, Malmstrom H, Peitsch MC, Hoeng J, Ren Y. Effects of different discoloration challenges and whitening treatments on dental hard tissues and composite resin restorations. J Dent. 2019 Oct;89:103182. doi: 10.1016/j.jdent.2019.103182. Epub 2019 Aug 17.
- Background: 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.
- Background: PubMed 35848886Huang M, Wang Y, Sun Y, Zhou Y, Liu Y, Ye H. The accuracies of three intraoral scanners with regard to shade determination: An in vitro study. J Prosthodont. 2023 Jun;32(5):111-117. doi: 10.1111/jopr.13571. Epub 2022 Aug 10.
- Background: PubMed 25275958Sabatini C. Color Stability Behavior of Methacrylate-based Resin Composites Polymerized with Light-emitting Diodes and Quartz-Tungsten-Halogen. Oper Dent. 2015 May-Jun;40(3):271-81. doi: 10.2341/14-080-L. Epub 2014 Oct 2.
- Background: PubMed 35915423El-Rashidy AA, Abdelraouf RM, Habib NA. Effect of two artificial aging protocols on color and gloss of single-shade versus multi-shade resin composites. BMC Oral Health. 2022 Aug 1;22(1):321. doi: 10.1186/s12903-022-02351-7.
- Background: PubMed 37710194Mahrous AI, Salama AA, Shabaan AA, Abdou A, Radwan MM. Color stability of two different resin matrix ceramics: randomized clinical trial. BMC Oral Health. 2023 Sep 14;23(1):665. doi: 10.1186/s12903-023-03364-6.
- 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 3 inclusion and 3 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 24 Jul 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?
Color stability evaluation (time frame: 18 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 NCT06510400, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.