- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04305483
Evaluation of the Color Change of the Laser and Chemical Vital Whitening Method in the Teeth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Tooth color; It is formed by the combination of enamel, dentin and pulp with different optical properties. Tooth coloring is divided into two as etiological, internal and external. External colorants can be removed simply by cleaning. Removal of intrinsic coloring is possible with chemical bleaching. In the treatment of tooth coloring, whitening is considered the least aggressive method.
Due to the increasing interest in aesthetics in recent years, patients' demands for teeth whitening have increased. Home-bleaching technique, developed by Haywood and Heymann in 1989, has been the most frequently used method until recently. In this method, the bleaching agent contains 10% hydrogen peroxide. For 2-5 weeks, whitening is performed by placing the gel in a plate by the patient every night. The advantages of this method are that it is easy to apply, low cost, use of lower rates of hydrogen peroxide, and less time spent in the clinic. However, the disadvantages are that the whitening process is not under the control of the physician, the patient does not apply the whitening gel regularly, and the procedure takes several weeks. Office-bleaching technique has been developed in order to make the bleaching process more controlled, to ensure color stability and to shorten the time. This technique, which contains a high concentration of (15-38%) hydrogen peroxide, is activated by heat or light sources. These sources include plasma arc, LED, UV lamps and laser. However, there is no consensus on the effectiveness of heat and light sources used in tooth whitening.
The light sources used during bleaching are expected to increase the effectiveness of the bleaching and shorten the processing time. Among these, plasma arc and diode lasers have a wide range of uses. Laser teeth whitening method has been applied for about 15 years and many laser devices have been recommended for this procedure. It is expected that the treatment time will decrease and the sensitivity that may occur in the teeth will decrease as a result of laser application. However, the superiority of laser bleaching compared to other methods is still controversial.
External root resorption and irritation in soft tissues can be observed during the teeth whitening, even if in a small amount. It is stated that the sensitivity of teeth after the procedure is the most common complication by some researchers, but disappears by itself after the end of the bleaching process.
The purpose of aesthetic applications in dentistry; morphological, optical and biological compatibility. Tooth color is one of the most important criteria of aesthetics. Clinically, two different methods are used in color selection. The first, visual method, includes evaluation with the naked eye. The second method is colorimeter, spectrophotometer etc. is the use of devices that measure color. During clinical applications, color selection of dental materials is done by using visual scales. Color selection by visual method is both subjective and difficult; it can also lead to inadequate results. During color selection, erroneous results may occur due to parameters such as ambient light, physician's experience and age, and eye fatigue.
Due to these existing disadvantages, systems such as spectrophotometers, colorimeters, digital color meters have been launched to assist the physician in color selection. In dentistry, spectrophotometers and colorimeters are used to overcome problems related to color selection with the eye. Although the visual method is used more in the selection of colors by clinicians, it is stated that the color measurements made by using the visual method and spectrophotometer together are quite successful.
Color is formed by the merge of wavelengths in a light beam. In order for an object to be visible, it must emit light or reflect light from a light source. From the point of view of dentistry, the property of objects to reflect the incoming light is more important. The incoming light usually consists of a mixture of various wavelengths, that is, it has a polychromatic feature. When light comes on an object, it absorbs certain wavelengths and reflects certain wavelengths. The human eye can distinguish light between wavelengths of 400-700 nμ. Nerve responses play a big role in the appearance of color. As a result of attached stimulation, the eye gets tired and the reaction of the eye decreases. Color separation is a subjective issue.
The first color specification was proposed by CIE in 1931. Although this system was developed in the following years, its principles have still not changed. CIE system uses 3 variables, X, Y and Z. These variables are based on the spectral response functions defined by the CIE observer. The CIE chromaticity diagram is also used to define the exact color. In another CIE color system, three variables are used: L *, a * and b *.
The spectrophotometer is a photometric appliance that is used to measure the transmittance, reflection and true absorption of color. They contain prisms or dispersing parts to create a continuous color line in their structure. Spectrophotometric color measurements may vary depending on the light source used and the measurement mode. Some spectrophotometers can be used according to two different measurement modes: Specular Component Included (SCI) and Excluded (SCE). Many types of standard light source are also used for color measurement of dental materials. These devices give three stimulus values x, y, z or CIE L *, a *, b *. These values can be converted into numerical values and color variables of different objects can be compared.
The aim of the study is to compare the color change caused by laser-activated and chemically activated vital whitening systems with two different evaluation methods (digital camera and spectrophotometer). In this way, a comparison of the effectiveness of both the whitening systems and the reliability of the evaluation methods will be made. It is also aimed to determine the sensitivity of the teeth that may occur during and after bleaching.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Van, Turkey, 65080
- Beyza Ünalan Değirmenci
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Systemically healthy individuals
- Non-smokers
- Those who do not consume more than three cups of tea / coffee per day
- No devital and / or restorated teeth in the upper anterior six teeth
Exclusion Criteria:
- Pregnancy
- Patient with hypersensitivity
- Patient with crack, exposed dentin
- Patients with dental caries
- Patient who have gingival recession
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Laser Bleaching
35% Hydrogen peroxide, potassium nitrate, sodium fluoride, sodium hydroxide, thickener, glycol derivative containing bleaching agent activated with diode laser
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Content; There are 35% hydrogen peroxide, potassium nitrate, sodium fluoride, sodium hydroxide, thickener, glycol derivative.
The way of application; Gingival protection is applied.
The gel is applied to the labial surfaces of the teeth with a thickness of 1-2 mm.
The use of laser increases the effectiveness of the gel.
Operator and patient use protective glasses during laser application.
The gel shows its effectiveness in about eight minutes.
Then the gel is removed with the help of saliva absorber.
The procedure is repeated until the desired degree of whitening is achieved.
Then it is checked with a color scale.
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Active Comparator: Chemical Bleaching
35% Hydrogen peroxide, thickener, plant extracts, amide, release agent, glycol, paint and water containing chemical bleaching agent used for control group without a laser activation
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"Total Blanc Office Teeth Whitening System (H35)" will be used as chemical whitening agent.
Content; There are 35% hydrogen peroxide, thickener, plant extracts, amide, release agent, glycol, paint and water.
Method of Application; Gingival protection is applied.
A 1 mm thick layer of gel is applied to all of the labial surfaces of the tooth.
The whitening agent remains on the tooth surface for 20 minutes.
At the end of this period, the gel is removed with saliva absorber and the surface is cleaned with a moist gauze.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Color change according to CIE Lab system
Time Frame: Immediately after procedure
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Before and after the bleaching procedure color of the maxillary anterior teeth were measured based on CIE Lab system with a spectrophotometer and digital photography machine.
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Immediately after procedure
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Color change according to CIE Lab system
Time Frame: After 2 weeks
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Before and after the bleaching procedure color of the maxillary anterior teeth were measured based on CIE Lab system with a spectrophotometer and digital photography machine.
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After 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the Procedural Sensitivity Levels
Time Frame: Immediately after procedure
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After the related bleaching procedure, operator wanted to evaluate sensitivity levels of the patients according to visual analogue scale.
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Immediately after procedure
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Evaluation of the Procedural Sensitivity Levels
Time Frame: After 2 weeks
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After the related bleaching procedure, operator wanted to evaluate sensitivity levels of the patients according to visual analogue scale.
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After 2 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Hahn P, Schondelmaier N, Wolkewitz M, Altenburger MJ, Polydorou O. Efficacy of tooth bleaching with and without light activation and its effect on the pulp temperature: an in vitro study. Odontology. 2013 Jan;101(1):67-74. doi: 10.1007/s10266-012-0063-4. Epub 2012 Mar 1.
- Kivanc BH, Arisu HD, Ulusoy OI, Saglam BC, Gorgul G. Effect of light-activated bleaching on pulp chamber temperature rise: an in vitro study. Aust Endod J. 2012 Aug;38(2):76-9. doi: 10.1111/j.1747-4477.2010.00271.x. Epub 2010 Oct 24.
- Lima DA, Aguiar FH, Liporoni PC, Munin E, Ambrosano GM, Lovadino JR. In vitro evaluation of the effectiveness of bleaching agents activated by different light sources. J Prosthodont. 2009 Apr;18(3):249-54. doi: 10.1111/j.1532-849X.2008.00420.x. Epub 2009 Feb 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05.12.2013/07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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