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Tooth DiscolorationNCT06666920

Er,Cr:YSGG Laser Bleaching on Tooth Color and Sensitivity

A study testing laser irradiation in people with Tooth Discoloration and Tooth Sensitivity, run by Aristotle University Of Thessaloniki at 1 site in Greece.

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

The aim of this split-mouth clinical study was to evaluate the tooth color (ΔΕab and ΔΕ00) and whiteness (ΔWID) changes, as well as tooth sensitivity (TS) induced after performing in-office tooth bleaching procedure with or without light-activation of the bleaching gel using Er,Cr:YSGG laser irradiation. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Tooth Discoloration, Tooth Sensitivity
What is being tested?
laser irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteGreece
Study dates
1 Oct 2018to 1 Oct 2022
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Good overall health
  • Healthy oral tissues
  • Vital upper and lower anterior teeth
  • No carious or non-carious lesions
  • Tooth shade A3 or darker

Who cannot join

  • Patients with direct or indirect restorations on their upper or lower anterior teeth.
  • Patients using orthodontic appliances.
  • Patients undergone previous bleaching treatments.
  • Patients with a history of adverse reactions to peroxides.
  • Patients taking opioid medications
  • Patients having pacemakers.
Show all 13Show fewer
  • Patients with severe tooth discoloration due to tetracycline, trauma, fluorosis, or other causes.
  • Patients with clinically verifiable dentin exposure; or those with dental sensitivity or a history of treatment for dental sensitivity.
  • Smokers.
  • Pregnant or lactating women.
  • Patients with neurological disorders.
  • Individuals taking medications that could cause photosensitivity.
  • Patients with chronic or acute diseases.

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • Aristotle University of Thessaloniki

    Thessaloniki, Central Makedonia, 54124

Other trials in Greece

About this study

Official title: Evaluation of Tooth Color Change and Sensitivity Following Laser-assisted In-office Tooth Bleaching Using Er,Cr:YSGG Laser: a Split-mouth Clinical Study

The aim of this split-mouth clinical study was to evaluate the tooth color (ΔΕab and ΔΕ00) and whiteness (ΔWID) changes, as well as tooth sensitivity (TS) induced after performing in-office tooth bleaching procedure with or without light-activation of the bleaching gel using Er,Cr:YSGG laser irradiation. Twenty patients with tooth shade A3 or darker were selected for this single-blinded, split-mouth study. The bleaching session was conducted with two 20-min sessions of a 40% hydrogen peroxide bleaching agent assisted by Er,Cr:YSGG laser (2780 nm) irradiation on one side (left) of the maxillary and mandibular teeth and without laser activation on the other hemiarch (right). ΔΕab, ΔΕ00 and ΔWID were evaluated in central incisors and canines using a clinical spectrophotometer immediately, 1 week and 1 month after the bleaching procedure. TS was evaluated pre-operatively and immediately post-operatively using a visual analogue scale (VAS).

Read the detailed description

The study description adheres to the guidelines of the Consolidated Standards of Reporting Trials (CONSORT) statement. A factorial, single-blind, split-mouth design was employed in this study, with the following factors being examined:

  1. Bleaching treatment: two treatment protocols were used, Group 1 (control) - 40% H2O2 bleaching agent and Group 2 - 40% H2O2 bleaching agent + Er,Cr:YSGG laser.
  2. Evaluation time: three time points were used for the analysis of bleaching efficacy (T1 at immediately after the treatment, T2 at 7 days after the treatment and T3 at 30 days after the treatment). All color measurements were compared with the baseline values recorded prior to the start of the bleaching treatments. Additionally, tooth sensitivity was assessed at two time points: T1, just before the treatments began, and T2, immediately after the treatments were completed. Patients and the researchers administering the bleaching treatment were not blinded, as it was not possible to conceal whether the bleaching gel was exposed to laser irradiation. However, the evaluator responsible for recording color and sensitivity remained blinded to the treatment conditions.

Bleaching procedure

The study took place at the Postgraduate Dental Clinic of the Department of Operative Dentistry of Aristotle University of Thessaloniki. Initially, twenty volunteers (11 women and 9 men) between the ages of 22 and 48 (mean age 31.1±7.0 years) were enrolled. Patient selection was based on clinical and radiographic examinations, along with a detailed medical history, all conducted prior to the bleaching treatments. Participants were informed about the study's purpose, as well as the potential risks and benefits of the experimental treatment. Those who agreed to participate signed an informed consent form and were provided with both written and verbal instructions regarding hygiene, bleaching gel application, and diet. One week before the tooth bleaching treatment a periodontal treatment using an ultrasonic scaler type Cavitron (KaVo Dental GmbH, Biberach/Riss, Germany) was carried out to remove any external stains or calculus deposits.

All patients received a conventional in-office bleaching treatment using a red-colored bleaching agent with a neutral pH, consisting of 40% H2O2 (Opalescence Boost™ PF 40%, Ultradent Products, Inc., South Jordan, UT, USA). According to the manufacturer's instructions, the contents of the two syringes were blended 25 times and applied in a layer approximately 1 mm thick on the labial surface of the anterior teeth and buccal surface of premolars. After application of a light-cured liquid dam on the gingiva, the bleaching gel was applied on the surface for 20 min, with agitation every 5 min, and subsequently removed using a surgical suction tip. This procedure was repeated for another 20 min (40 min in total) and finally a thorough rinsing with water was followed.

Er,Cr:YSGG laser treatment

Immediately after applying the bleaching agent, the gel on the left upper and lower hemiarches (teeth 21-25 and 31-35) was irradiated using an Er,Cr:YSGG laser (2780 nm). Specifically, an Er,Cr:YSGG solid-state laser device (Waterlase MD Turbo, BIOLASE, Irvine, CA, USA) equipped with a Z-type glass tip (MZ8) measuring 800 μm in diameter and 6 mm in length was used. This tip was attached to the laser system's gold handpiece. The laser parameters for the treatment included an average output power of 1.25 W, a pulse duration of 700 μs (S-mode), and a pulse repetition rate of 10 Hz, without water or air flow, according to a previous study [Dionysopoulos]. Each tooth received two 15-s irradiation intervals, one for each 20-min session (totaling 30 s), while maintaining the laser handpiece approximately 2.5 cm from the tooth surface, perpendicular to the enamel. The gel was irradiated using a scanning mode, with the handpiece moved slowly in both horizontal and vertical directions at a speed of 2 mm/s. This was done to ensure uniform irradiation and complete coverage of the entire surface of the bleaching gel. The fluence for each pulse was 0.45 J/cm², well below the ablation threshold for enamel [Apel]. Each tooth received a total energy of 21.6 J, with an energy delivery rate of 0.72 J/s. To reduce operator variability, the same researcher performed all the whitening procedures.

Evaluation of tooth color and whiteness changes

Color and whiteness changes were evaluated using a spectrophotometer (SpectroShade™, MHT Optic Research AG, Milan, Italy). The measurements were performed at four time points: a) before the bleaching treatment (baseline), b) immediately after the bleaching treatment, c) one week after the bleaching treatment (7 days) and d) one month after the bleaching treatment (30 days). Calibration of the spectrophotometer was carried out at the beginning of each set of measurements using the white and green standards contained in the rechargeable base. Only the center portion of the tooth was used for the collection of data according to Commission Internationale de l'Eclairage Lab (CIELAB) color space. All measurements were repeated twice and averaged under the same light conditions. If ΔΕ between two recordings of the same specimen exceeded 1, new measurements were obtained. The measurements were implemented at room temperature (23±1°C) by the same operator, who did not know which experimental group was measured.

Tooth sensitivity assessment

Tooth sensitivity was analyzed using a visual analog scale (VAS). The scale was represented by a 10 cm horizontal line, limited by two expressions at its ends, with the words "no pain" and "worst pain". Patients were asked about the intensity of spontaneous discomfort caused by the treatment and their responses were scored on the scale, where 0 indicated that patients did not present any painful symptoms and 10 indicated the occurrence of severe sensitivity. When the patient reported sensitivity, they were questioned about the hemiarch in which it occurred, and this information was noted. The values considered on two categories were the percentage of participants who had sensitivity in each treatment group and the intensity of dental sensitivity by treatment group. The analysis between the proportions of patients with sensitivity was performed by Fisher's exact test. The comparison between the intensity of sensitivity on both sides of the split-mouth design was performed by the Mann Whitney test. For both tests, the global level of significance was 95% (α= 0.05).

Being tested
laser irradiation
Keywords
Tooth color change, Laser-assisted tooth bleaching, Spectrophotometer, Tooth sensitivity, Whiteness index
Medical subject headings
Tooth Discoloration, Dentin Sensitivity

What participants receive

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

  • laser irradiationRadiation

    Immediately after applying the bleaching agent, the gel on the left upper and lower hemiarches (teeth 21-25 and 31-35) was irradiated using an Er,Cr:YSGG laser (2780 nm). Specifically, an Er,Cr:YSGG solid-state laser device (Waterlase MD Turbo, BIOLASE, Irvine, CA, USA) equipped with a Z-type glass tip (MZ8) measuring 800 μm in diameter and 6 mm in length was used. This tip was attached to the laser system's gold handpiece. The laser parameters for the treatment included an average output power of 1.25 W, a pulse duration of 700 μs (S-mode), and a pulse repetition rate of 10 Hz, without water or air flow, according to a previous study. Each tooth received two 15-s irradiation intervals, one for each 20-min session (totaling 30 s), while maintaining the laser handpiece approximately 2.5 cm from the tooth surface, perpendicular to the enamel. The gel was irradiated using a scanning mode, with the handpiece moved slowly in both horizontal and vertical directions at a speed of 2 mm/s.

Study groups in NCT06666920
Study groupRoleWhat they receive
Laser-assisted tooth bleaching techniqueExperimentalThe left hemiarches of the patient's dentition received laser treatment during tooth bleaching procedure
Receives: Radiation: laser irradiation
Conventional tooth bleaching techniqueNo interventionThe right hemiarches of the patient's dentition received laser treatment during tooth bleaching procedure

What is being measured

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

  1. Tooth color and whiteness changes

    Tooth color and whiteness changes will be evaluated using a clinical spectrophotometer. According to Commission Internationale de l'Eclairage Lab (CIELAB) color space tooth color change (ΔEab) using the CIELAB system was determined using equation (1):

    ΔEab = [(ΔL)2 + (Δa)2 + (Δb)2]1/2 (1)

    Moreover, tooth color change using the CIEDE2000 system, employing the h (hue) and C (chroma) values was calculated using equation (2):

    ΔE00 = [(ΔL'/KLSL)2 + (ΔC'/KCSC)2 + (ΔH'/KHSH)2 + RT × (ΔC'/KCSC) × (ΔH'/KHSH)]1/2 (2)

    The Whiteness Index for Dentistry (WID) was evaluated based on CIELAB parameters before and after the bleaching treatments, using equations (3) and (4):

    WID= 0.511L - 2.324a - 1.100b (3) ΔWID= WIDi - WID0 (4)

    Measured: The measurements were performed at four time points: a) before the bleaching treatment (baseline), b) immediately after the bleaching treatment, c) one week after the bleaching treatment (7 days) and d) one month after the bleaching treatment (30 days).

Secondary outcomes (1)
  1. Tooth sensitivity

    Tooth sensitivity was analyzed using a visual analog scale (VAS). The scale was represented by a 10 cm horizontal line, limited by two expressions at its ends, with the words "no pain" and "worst pain" (Fig. 1). Patients were asked about the intensity of spontaneous discomfort caused by the treatment and their responses were scored on the scale, where 0 indicated that patients did not present any painful symptoms and 10 indicated the occurrence of severe sensitivity. When the patient reported sensitivity, they were questioned about the hemiarch in which it occurred, and this information was noted. The values considered on two categories were the percentage of participants who had sensitivity in each treatment group and the intensity of dental sensitivity by treatment group.

    Measured: Measurements were carried out before and immediately after the bleaching procedure

Timeline

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

  1. First posted31 Oct 2024
  2. Study start1 Oct 2018
  3. Primary completion1 Jul 2022
  4. Study completion1 Oct 2022

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06666920
Sponsor's protocol ID
31/23-03-2016
Status last verified
Oct 2024
First submitted
27 Oct 2024
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing laser irradiation in people with Tooth Discoloration and Tooth Sensitivity, run by Aristotle University Of Thessaloniki at 1 site in Greece.

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 5 inclusion and 13 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 31 Oct 2024. 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 Greece. 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?

Tooth color and whiteness changes (time frame: The measurements were performed at four time points: a) before the bleaching treatment (baseline), b) immediately after the bleaching treatment, c) one week after the bleaching treatment (7 days) and d) one month after the bleaching treatment (30 days).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 31 Oct 2024.

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