search
Back to results

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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Teeth

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with fractured incisal angle.
  2. Vital teeth.
  3. Anterior Permanent teeth.
  4. Good oral hygiene.
  5. Co-operative patients approving to participate in the study.

Exclusion Criteria:

  1. Non vital teeth.
  2. Severe or active periodontal disease.
  3. Severe medical complications.
  4. 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

    First Posted
    April 17, 2020
    Last Updated
    April 21, 2020
    Sponsor
    Cairo University
    search

    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

    We'll reach out to this number within 24 hrs