Discoloration, ToothNCT05315518
Effect of Using Shade Blocker Versus Chameleon Effect of Two Single Shade of Resin Composite in Class IV Restorations
A study testing single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker) in people with Discoloration, Tooth, run by Cairo University.
Trial summary
Aim of this study will be conducted to compare the shade matching and clinical performance of shade blocker versus chameleon effect of two single-shade of universal resin composite in class IV restorations over 1 year evaluation period Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Discoloration, Tooth
- What is being tested?
- single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2022to 7 Apr 2023
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- moderate class IV defect with no lingual wall presence of favorable occlusion and teeth are in normal contact with the adjacent teeth good oral hygiene cooperative patients
- -
Who cannot join
- tooth hypersensitivity severe periodontal affection non vital teeth heavy smoking
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Using Shade Blocker Versus Chameleon Effect on Shade Matching of Two Single-shade Resin Composite Materials in Class IV Restorations: A One Year Randomized Clinical Trial
Aim of this study will be conducted to compare the shade matching and clinical performance of shade blocker versus chameleon effect of two single-shade of universal resin composite in class IV restorations over 1 year evaluation period
Read the detailed description
The color matching of both groups will be evaluated visually using modified USPH criteria
- Conditions
- Discoloration, Tooth
- Being tested
- single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker)
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker)Diagnostic test
(OMNICHROMA BLOCKER) is indicated for preventing shade-matching interference in Class IV restorations, Masking dark dentition and dentin. In cases where there is a lack of tooth structure to bond to, (BLOCKER) works as a supplementary product to provide a lingual wall to the restoration, prevent shade-match obstruction and mask staining.
| Study group | Role | What they receive |
|---|---|---|
| single shade universal resin composite (omnichroma) with blocker | Experimental | (OMNICHROMA BLOCKER) is indicated for preventing shade-matching interference in Class IV restorations, Masking dark dentition and dentin. In cases where there is a lack of tooth structure to bond to, (BLOCKER) works as a supplementary product to provide a lingual wall to the restoration, prevent shade-match obstruction and mask staining. Receives: Diagnostic Test: single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker) |
| single shade universal resin composite(GC solare sculpt) with chameleon effect | Active comparator | One-shade universal resin composite (GC solare sculpt) gives very natural appearance, High gloss retention over time, time saving regarding to layering technique, wide shade matching range (chameleon effect) and delivering lifelike aesthetic restorations. These features can be offered by supra-nano spherical filler which have controlled refractive index, records excellent esthetic properties in small and medium class IV restorations. Receives: Diagnostic Test: single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker) |
What is being measured
The primary outcome is the main question the study is designed to answer.
shade matching
the shade matching of both groups will be assessed visually by using modified USPH criteria.
score: 1- Alpha : the restoration match the shade and translucency of the adjacent tooth 2-Bravo : there is a mismatch in the shade and translucency but it is within a normal range of tooth shade 3- Charlie: the mismatch is beyond the normal range of the tooth shade and translucency
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start5 Sep 2022 (estimated)
- Primary completion5 Oct 2022 (estimated)
- Study completion7 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discoloration, ToothStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sarah ali mohamed ahmed, Cairo University
- Investigators
- sarah ahmed, master, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315518
- Sponsor's protocol ID
- OPR 14/3/2022
- Status last verified
- Jul 2022
- First submitted
- 17 Mar 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The aim of the study is to compare the shade matching and clinical performance of shade blocker versus chameleon effect of two single-shade universal resin composite in class IV restorations over 1year evaluation period.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Shade Blocker Versus Chameleon Effect on Shade Matching of Two Single-shade Resin Composite Materials in Class IV Restorations: A One Year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05315518
- Acronym / sponsor ID
- OPR 14/3/2022
- Conditions
- Discoloration, Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Sep 2022 (estimated)
- Primary completion
- 5 Oct 2022 (estimated)
- Study completion
- 7 Apr 2023 (estimated)
- First posted
- 7 Apr 2022 (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.
Aim of this study will be conducted to compare the shade matching and clinical performance of shade blocker versus chameleon effect of two single-shade of universal resin composite in class IV restorations over 1 year evaluation period
Detailed description
The color matching of both groups will be evaluated visually using modified USPH criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single shade universal resin composite (omnichroma) with blocker | Experimental | Diagnostic Test: single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker)(OMNICHROMA BLOCKER) is indicated for preventing shade-matching interference in Class IV restorations, Masking dark dentition and dentin. In cases where there is a lack of tooth structure to bond to, (BLOCKER) works as a supplementary product to provide a lingual wall to the restoration, prevent shade-match obstruction and mask staining. |
| single shade universal resin composite(GC solare sculpt) with chameleon effect | Active comparator | Diagnostic Test: single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker)One-shade universal resin composite (GC solare sculpt) gives very natural appearance, High gloss retention over time, time saving regarding to layering technique, wide shade matching range (chameleon effect) and delivering lifelike aesthetic restorations. These features can be offered by supra-nano spherical filler which have controlled refractive index, records excellent esthetic properties in small and medium class IV restorations. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- moderate class IV defect with no lingual wall presence of favorable occlusion and teeth are in normal contact with the adjacent teeth good oral hygiene cooperative patients
- -
Key exclusion criteria (1 listed)
- tooth hypersensitivity severe periodontal affection non vital teeth heavy smoking
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 |
|---|---|---|
| single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker)(OMNICHROMA BLOCKER) is indicated for preventing shade-matching interference in Class IV restorations, Masking dark dentition and dentin. In cases where there is a lack of tooth structure to bond to, (BLOCKER) works as a supplementary product to provide a lingual wall to the restoration, prevent shade-match obstruction and mask staining. | Diagnostic test | single shade universal resin composite (omnichroma) with blocker, single shade universal resin composite(GC solare sculpt) with chameleon effect |
Primary outcome
shade matching
Time frame: 12 months
the shade matching of both groups will be assessed visually by using modified USPH criteria. score: 1- Alpha : the restoration match the shade and translucency of the adjacent tooth 2-Bravo : there is a mismatch in the shade and translucency but it is within a normal range of tooth shade 3- Charlie: the mismatch is beyond the normal range of the tooth shade and translucency
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: Yes. The aim of the study is to compare the shade matching and clinical performance of shade blocker versus chameleon effect of two single-shade universal resin composite in class IV restorations over 1year evaluation period.
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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.
sarah ahmed, master principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker) in people with Discoloration, Tooth, run by Cairo University.
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 1 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 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sarah ahmed, master (01015139628, sarah.mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shade matching (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2022.