Anterior TeethNCT04355208
Shade Evaluation of Monochromatic Versus Polychromatic Layering Techniques Inrestoration of Fractured Incisal Angle
A study testing (3M™ Filtek™ Universal ) in people with Anterior Teeth, run by Cairo University.
Trial summary
This clincl trial will be conducted to compare theShade Evaluation of Monochromatic versus Polychromatic layering techniques in restoration of Fractured incisal angle Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anterior Teeth
- What is being tested?
- (3M™ Filtek™ Universal )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to May 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with fractured incisal angle.
- Vital teeth.
- Anterior Permanent teeth.
- Good oral hygiene.
- Co-operative patients approving to participate in the study.
Who cannot join
- Non vital teeth.
- Severe or active periodontal disease.
- Severe medical complications.
- Uncooperative patients
About this study
Official title: Shade Evaluation of Monochromatic Versus Polychromatic Layering Techniques in Restoration of Fractured Incisal Angle: Randomized Controlled Trial
This clincl trial will be conducted to compare theShade Evaluation of Monochromatic versus Polychromatic layering techniques in restoration of Fractured incisal angle
Read the detailed description
The use of enamel and dentin shades allow us to reproduce anatomical features such as incisal edge translucency, halo effect, other internal colors and pigments such as craze lines, white patches, white horizontal striations .
Anterior composites usually have small filler particles to increase smoothness, nanotechnology has enabled recent advances in dental composite restorations. As a result , a different category of composite resins has emerged, known as nanocomposites.
However polychromatic layering is considered to be technique sensitive, from detection of details to proper reproduction of such fine details.
The presence of discrepancies between the classic shade guides and the actual shade of composite makes that task more difficult.
The use of monochromatic layering with only body shade can serve as a substitute for enamel and dentin, since it has an intermediate opacity between enamel and dentin , and can serve as an easier option with less technique sensitivity than polychromatic layering.
Filtek universal as claimed by the company manufacturer to have A "NaturalMatch" which is a term that describes the combination of 3M technologies and features present within 3M™ Filtek™ Universal restorative.
it contains nanofillers, pigments and proprietary low-stress monomers which gives Filtek™ Universal Restorative a combination of esthetic and universal opacity which in turn allow shade blending and making the restoration more invisible with surrounding dentition.
- Conditions
- Anterior Teeth
- Being tested
- (3M™ Filtek™ Universal )
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(3M™ Filtek™ Universal )Other
universal nanofillers resin composite (3M™ Filtek™ Universal )
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Restoration of anterior teeth using monochromatic layering technique using body shade (filtek universal from 3m Receives: Other: (3M™ Filtek™ Universal ) |
| comparator | Active comparator | Restoration of anterior teeth using polychromatic layering technique using Enamel and Dentin shades (filtek Z350 xt from 3m Receives: Other: (3M™ Filtek™ Universal ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shade matching
shade matching using Modified USPHS Criteria and Visual inspection using Digital Photography
Measured: immediate after restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study startOct 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior TeethStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Badry Khalaf Hashem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355208
- Sponsor's protocol ID
- 3M™ Filtek™ Universal
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shade Evaluation of Monochromatic Versus Polychromatic Layering Techniques in Restoration of Fractured Incisal Angle: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04355208
- Acronym / sponsor ID
- 3M™ Filtek™ Universal
- Conditions
- Anterior Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 21 Apr 2020 (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.
This clincl trial will be conducted to compare theShade Evaluation of Monochromatic versus Polychromatic layering techniques in restoration of Fractured incisal angle
Detailed description
The use of enamel and dentin shades allow us to reproduce anatomical features such as incisal edge translucency, halo effect, other internal colors and pigments such as craze lines, white patches, white horizontal striations .
Anterior composites usually have small filler particles to increase smoothness, nanotechnology has enabled recent advances in dental composite restorations. As a result , a different category of composite resins has emerged, known as nanocomposites.
However polychromatic layering is considered to be technique sensitive, from detection of details to proper reproduction of such fine details.
The presence of discrepancies between the classic shade guides and the actual shade of composite makes that task more difficult.
The use of monochromatic layering with only body shade can serve as a substitute for enamel and dentin, since it has an intermediate opacity between enamel and dentin , and can serve as an easier option with less technique sensitivity than polychromatic layering.
Filtek universal as claimed by the company manufacturer to have A "NaturalMatch" which is a term that describes the combination of 3M technologies and features present within 3M™ Filtek™ Universal restorative.
it contains nanofillers, pigments and proprietary low-stress monomers which gives Filtek™ Universal Restorative a combination of esthetic and universal opacity which in turn allow shade blending and making the restoration more invisible with surrounding dentition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: (3M™ Filtek™ Universal )Restoration of anterior teeth using monochromatic layering technique using body shade (filtek universal from 3m |
| comparator | Active comparator | Other: (3M™ Filtek™ Universal )Restoration of anterior teeth using polychromatic layering technique using Enamel and Dentin shades (filtek Z350 xt from 3m |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with fractured incisal angle.
- Vital teeth.
- Anterior Permanent teeth.
- Good oral hygiene.
- Co-operative patients approving to participate in the study.
Key exclusion criteria (4 listed)
- Non vital teeth.
- Severe or active periodontal disease.
- Severe medical complications.
- Uncooperative patients
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 |
|---|---|---|
| (3M™ Filtek™ Universal )universal nanofillers resin composite (3M™ Filtek™ Universal ) | Other | Intervention, comparator |
Primary outcome
Shade matching
Time frame: immediate after restoration
shade matching using Modified USPHS Criteria and Visual inspection using Digital Photography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing (3M™ Filtek™ Universal ) in people with Anterior Teeth, 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 5 inclusion and 4 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 22 Apr 2020. 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?
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 (time frame: immediate after restoration). 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 22 Apr 2020.