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Measurements of Color Matching and Blending Effect

Primary Purpose

Tooth Decay

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shaded bulk-fill resin composite
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Decay

Eligibility Criteria

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

Inclusion Criteria:

  • People with simple class I posterior teeth would be selected without any preference of age or gender.
  • Selected molars should only shaded A2, and A3 as these are shades under investigation.
  • Patients with multiple caries teeth are preferred.
  • Patients should be medically free and with good health.
  • Selected molars should be vital.
  • Patients should accept participation in the study.

Exclusion Criteria:

  • Very deep carious molars that are indicated for root canal treatment or pulp capping.
  • Teeth which are cracked, badly decayed crowns, non-restorable, periodontally affected, non-vital or abscessed.
  • Patients who refuse to accept participation or had psychological disturbance will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Translucent bulk-fill resin composite

    Shaded bulk-fill resin composite

    Arm Description

    *Shaded bulk-fill resin composite. Bulk-fill resin composite which has no shade and could match any other shade. It will be compared for shade accuracy to the haded bulk-fill resin composite.

    *Translucent bulk-fill resin composite Bulk-fill resin composite which has a specific shade and should only be filled in teeth with the corresponding shade

    Outcomes

    Primary Outcome Measures

    In-vivo visual color matching and blending effect by visual Score from 1 to 5
    Visual score from 1-5. The rank (1) is for mismatch or totally unaccepted, (2) is for poor match or hardly accepted, (3) is for good match or accepted, (4) is for close match or small difference, (5) is for exact match or no color difference

    Secondary Outcome Measures

    Full Information

    First Posted
    January 31, 2017
    Last Updated
    March 3, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03045900
    Brief Title
    Measurements of Color Matching and Blending Effect
    Official Title
    Measurements of Color Matching and Blending Effect of Translucent and Shaded Bulk-fill Resin Composites [Ex-vivo and In-vivo Study]
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2017 (Anticipated)
    Primary Completion Date
    August 15, 2017 (Anticipated)
    Study Completion Date
    October 15, 2017 (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
    There is a deficiency in literature which compares the blending effect and color matching of translucent shade bulk-fill resin composite with shaded bulk-fill resin composite. So in this research color matching and blending effect will be instrumentally measured the by a spectrophotometer. A visual assessment also will be done in-vivo and ex-vivo.
    Detailed Description
    Color matching may be the only parameter of treatment with which the patient is concerned. Failure to match the proper color of the teeth may lead to failure of mechanically and biologically successful restoration. Up to 80% of the patients expressed their dissatisfaction with the perceived color of their dental restorations. Thus, proper color reproduction is considered to be one of the most complex and frustrating problems in restorative dentistry. Polymerisation shrinkage is another serious problem that causes entrapment of stresses that may shorten the clinical life of the restoration. In an effort to reduce this, resin composite is placed in increments as each increment compensate for the previous one. These increments are usually 2 mm each to allow the penetration of curing light. As the resin shade is darker and the filler size is larger, the curing depth will be more limited. So no doubt that the more translucent is the shade of the resin, the higher is the depth of cure. It is noted that, incremental placement is a tedious, time consuming and a very sensitive technique. Improper placement may result in air bubble entrapment or porosity that may result in a weak restoration. The bulk-fill resin composites specifically designed for large posterior restorations. They represent a new era in direct filling technology and a paradigm shift away from the traditional 2 mm increment system. Bulk-fill resin composite are possible to be cured in a depth of 3.5 to 5.5 mm. This reduces effort and time of the procedure and guarantees a solution for the polymerization shrinkage problem. It is important to note that bulk-fill materials do not constitute a uniform class of materials, they have different consistencies sculptable and flowable. Also some companies produce a translucent shade that should match almost all teeth color as they claim. This is called blending effect where the material can take the shade of the surrounding tooth structure and thus guarantee a solution for color matching problem. Also there is a deficiency in literature that compares the blending effect and color matching of translucent shade bulk-fill resin composite with shaded bulk-fill resin composite. So in this research we will assess the effect of shaded bulk-fill resin composites against the translucent shade bulk-fill resin composite in-vivo and ex-vivo by spectrophotometer and visual inspection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Decay

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Translucent bulk-fill resin composite
    Arm Type
    Active Comparator
    Arm Description
    *Shaded bulk-fill resin composite. Bulk-fill resin composite which has no shade and could match any other shade. It will be compared for shade accuracy to the haded bulk-fill resin composite.
    Arm Title
    Shaded bulk-fill resin composite
    Arm Type
    Experimental
    Arm Description
    *Translucent bulk-fill resin composite Bulk-fill resin composite which has a specific shade and should only be filled in teeth with the corresponding shade
    Intervention Type
    Other
    Intervention Name(s)
    Shaded bulk-fill resin composite
    Intervention Description
    Dental bulk-fill resin composite with shades A1, A2, A3
    Primary Outcome Measure Information:
    Title
    In-vivo visual color matching and blending effect by visual Score from 1 to 5
    Description
    Visual score from 1-5. The rank (1) is for mismatch or totally unaccepted, (2) is for poor match or hardly accepted, (3) is for good match or accepted, (4) is for close match or small difference, (5) is for exact match or no color difference
    Time Frame
    Immediately in the same visit

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: People with simple class I posterior teeth would be selected without any preference of age or gender. Selected molars should only shaded A2, and A3 as these are shades under investigation. Patients with multiple caries teeth are preferred. Patients should be medically free and with good health. Selected molars should be vital. Patients should accept participation in the study. Exclusion Criteria: Very deep carious molars that are indicated for root canal treatment or pulp capping. Teeth which are cracked, badly decayed crowns, non-restorable, periodontally affected, non-vital or abscessed. Patients who refuse to accept participation or had psychological disturbance will be excluded.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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