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
About this trial
This is an interventional treatment trial for Tooth Decay
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.
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
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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Measurements of Color Matching and Blending Effect
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