Measurements of Color Matching and Blending Effect

March 3, 2017 updated by: Abd Allah Nagy Mohamed Abd El Fatah, Cairo University

Measurements of Color Matching and Blending Effect of Translucent and Shaded Bulk-fill Resin Composites [Ex-vivo and In-vivo Study]

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Translucent bulk-fill resin composite
*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.
Other: Shaded bulk-fill resin composite
Dental bulk-fill resin composite with shades A1, A2, A3
EXPERIMENTAL: Shaded 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
Other: Shaded bulk-fill resin composite
Dental bulk-fill resin composite with shades A1, A2, A3

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
In-vivo visual color matching and blending effect by visual Score from 1 to 5
Time Frame: Immediately in the same visit
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
Immediately in the same visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEBD-CU-2017-1-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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