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Color; Change Teeth, PosteruptiveNCT04305483

Evaluation of the Color Change of the Laser and Chemical Vital Whitening Method in the Teeth

A study testing Laser Bleaching and Chemical Bleaching in people with Color; Change Teeth, Posteruptive, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Having an aesthetic smile has become very common among patients today. Recent studies have shown that people aged 18-49 want to have whiter and brighter teeth. The demand for whitening has increased by 300% in the last 5 years. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Color; Change Teeth, Posteruptive
What is being tested?
Laser Bleaching and Chemical Bleaching
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2013to 13 Mar 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Pregnancy
  • Patient with hypersensitivity
  • Patient with crack, exposed dentin
  • Patients with dental caries
  • Patient who have gingival recession

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Beyza Ünalan Değirmenci

    Van, 65080

Other trials in Turkey (Türkiye)

About this study

Having an aesthetic smile has become very common among patients today. Recent studies have shown that people aged 18-49 want to have whiter and brighter teeth. The demand for whitening has increased by 300% in the last 5 years. New materials and equipment have been developed to meet this demand, and various whitening techniques have been developed for use at home and in clinical practice. Determination of color in dentistry; It can be divided into two categories with the help of visual and computer-aided devices. Eye color determination is the most widely used method during the construction of a indirect restoration. The evaluation of tooth color by eye is quite subjective. Physiological variables such as external light source, experience, age and human eye fatigue, color blindness cause inadequate results. Due to interpersonal detection differences during color perception, the lack of standardization in the determination of tooth color can be improved with the use of computer-aided devices such as spectroradiometer, spectrophotometer, colorimeter and with the help of film-based photographs and digital photographs. Spectrophotometric approach; the point of view is interesting, as it allows for an objective application, regardless of the practitioner's experience. The color selection made with the use of these devices provides a potential advantage over the color selection made with the eye. Because these measurements are objective, can be counted and can be obtained faster. Although widespread uses of computer aided colorimeters and spectrophotometers have been reported in dental studies, most devices are not suitable for routine clinical use. Color analysis with these computer-aided devices may cause inaccurate results especially in the evaluation of translucent objects such as teeth. Therefore, a combination using both eyes and devices should be used.

Read the 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.

Being tested
Laser Bleaching, Chemical Bleaching
Keywords
Vital Bleaching, Color measurement, spectrophotometer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laser BleachingProcedure or surgery

    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.

  • Chemical BleachingProcedure or surgery

    "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.

Study groups in NCT04305483
Study groupRoleWhat they receive
Laser BleachingActive comparator35% Hydrogen peroxide, potassium nitrate, sodium fluoride, sodium hydroxide, thickener, glycol derivative containing bleaching agent activated with diode laser
Receives: Procedure: Laser Bleaching
Chemical BleachingActive comparator35% Hydrogen peroxide, thickener, plant extracts, amide, release agent, glycol, paint and water containing chemical bleaching agent used for control group without a laser activation
Receives: Procedure: Chemical Bleaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Color change according to CIE Lab system

    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.

    Measured: Immediately after procedure

  2. Color change according to CIE Lab system

    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.

    Measured: After 2 weeks

Secondary outcomes (2)
  1. Evaluation of the Procedural Sensitivity Levels

    After the related bleaching procedure, operator wanted to evaluate sensitivity levels of the patients according to visual analogue scale.

    Measured: Immediately after procedure

  2. Evaluation of the Procedural Sensitivity Levels

    After the related bleaching procedure, operator wanted to evaluate sensitivity levels of the patients according to visual analogue scale.

    Measured: After 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2020
  2. Study start1 Dec 2013
  3. Primary completion24 Feb 2014
  4. Study completion13 Mar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04305483
Sponsor's protocol ID
05.12.2013/07
Status last verified
Mar 2020
First submitted
8 Mar 2020
Last updated
12 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 22395767
  • 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.

    PubMed 22827820
  • 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.

    PubMed 19210610

Questions about this trial

What is this clinical trial studying?

A study testing Laser Bleaching and Chemical Bleaching in people with Color; Change Teeth, Posteruptive, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Color change according to CIE Lab system (time frame: Immediately after procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04305483, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.

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