Shade Evaluation of Monochromatic Versus Polychromatic Layering Techniques Inrestoration of Fractured Incisal Angle
Primary Purpose
Anterior Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
(3M™ Filtek™ Universal )
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Teeth
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
comparator
Arm Description
Restoration of anterior teeth using monochromatic layering technique using body shade (filtek universal from 3m
Restoration of anterior teeth using polychromatic layering technique using Enamel and Dentin shades (filtek Z350 xt from 3m
Outcomes
Primary Outcome Measures
Shade matching
shade matching using Modified USPHS Criteria and Visual inspection using Digital Photography
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04355208
Brief Title
Shade Evaluation of Monochromatic Versus Polychromatic Layering Techniques Inrestoration of Fractured Incisal Angle
Official Title
Shade Evaluation of Monochromatic Versus Polychromatic Layering Techniques in Restoration of Fractured Incisal Angle: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Restoration of anterior teeth using monochromatic layering technique using body shade (filtek universal from 3m
Arm Title
comparator
Arm Type
Active Comparator
Arm Description
Restoration of anterior teeth using polychromatic layering technique using Enamel and Dentin shades (filtek Z350 xt from 3m
Intervention Type
Other
Intervention Name(s)
(3M™ Filtek™ Universal )
Intervention Description
universal nanofillers resin composite (3M™ Filtek™ Universal )
Primary Outcome Measure Information:
Title
Shade matching
Description
shade matching using Modified USPHS Criteria and Visual inspection using Digital Photography
Time Frame
immediate after restoration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Shade Evaluation of Monochromatic Versus Polychromatic Layering Techniques Inrestoration of Fractured Incisal Angle
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