- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04355208
Shade Evaluation of Monochromatic Versus Polychromatic Layering Techniques Inrestoration of Fractured Incisal Angle
Shade Evaluation of Monochromatic Versus Polychromatic Layering Techniques in Restoration of Fractured Incisal Angle: Randomized Controlled Trial
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with fractured incisal angle.
- Vital teeth.
- Anterior Permanent teeth.
- Good oral hygiene.
- Co-operative patients approving to participate in the study.
Exclusion Criteria:
- Non vital teeth.
- Severe or active periodontal disease.
- Severe medical complications.
- Uncooperative patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Restoration of anterior teeth using monochromatic layering technique using body shade (filtek universal from 3m
|
universal nanofillers resin composite (3M™ Filtek™ Universal )
|
Active Comparator: comparator
Restoration of anterior teeth using polychromatic layering technique using Enamel and Dentin shades (filtek Z350 xt from 3m
|
universal nanofillers resin composite (3M™ Filtek™ Universal )
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shade matching
Time Frame: immediate after restoration
|
shade matching using Modified USPHS Criteria and Visual inspection using Digital Photography
|
immediate after restoration
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3M™ Filtek™ Universal
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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