Color; Change Teeth, PosteruptiveNCT04537754
Clinical Comparison of LED- and Diode Laser-activated Bleaching
A study testing bleaching device in people with Color; Change Teeth, Posteruptive, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
To clinically compare the effects of LED- or Diode laser-activated bleaching on colour change, tooth-sensitivity, gingival-irritation and temperature variation over 9-months. Thirty-five patients with tooth colour A2 or higher will be included in the study. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Color; Change Teeth, Posteruptive
- What is being tested?
- bleaching device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2018to 5 May 2019
- 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 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy vital anterior teeth without restorations which have A2 or darker tooth shade on Vita Classical Scale (Vita Classical Scale, VITA Zahnfabrik, Bad Säckingen, Germany).
Who cannot join
- Pregnant or lactating woman smokers Participants with periodontal diseases, tooth sensitivity internal tooth discoloration (tetracycline/ fluorosis stains), exposed engine, peroxides allergy malpositioned teeth
Trial locations and contacts
1 site in 1 country.
About this study
To clinically compare the effects of LED- or Diode laser-activated bleaching on colour change, tooth-sensitivity, gingival-irritation and temperature variation over 9-months.
Thirty-five patients with tooth colour A2 or higher will be included in the study. In a split-mouth design, using a 35% HP bleaching agent (Whiteness HP); one side of each mouth will be randomly activated by a diode laser (Epic X) and the other side by an LED (Radii Plus) light-source. During bleaching, the temperature variations will be recorded using a thermocouple from the buccal surface of canine teeth. Colour change (ΔSGU, ΔE) will be evaluated by subjective (Vita classic/bleached guide) and objective methods (spectrophotometry) before treatment and immediately, 48h, 1 week, 1, 6, 9 months after. Tooth-sensitivity and gingival- irritation will be assessed by visual analogue scale (VAS) and Gingival Index.
Read the detailed description
Objective: The aim of this split-mouth, randomized clinical study is to evaluate the effect of LED or Diode laser-activated bleaching applications on colour change, tooth sensitivity, gingival irritation and temperature variation with 35% hydrogen peroxide bleaching gel after 9 months. Material and Methods: Thirty-five patients with anterior teeth without caries and no restoration will be included in this study. In a split-mouth design, a bleaching agent containing 35% HP (Whiteness HP, FGM) will be used, one side of each jaw will be activated by a diode laser (Epic X, Biolase) and the other side will be activated by an LED (Radii Plus, SDI) light source. During the bleaching treatments, the temperature variations will be recorded using a thermocouple (DT-3891G K type Thermometer datalogger, CEM Instruments) from the buccal surface of canine teeth. Tooth sensitivity will be assessed by Visual Analogue Scale (VAS) before the treatment and during, immediately, 48 hours, 1 week, 1, 6 and 9 months after. Color change will be evaluated by subjective (Vita Classic and Vita 3D Master Bleachguide) and objective methods (Vita Easy Shade, spectrophotometer) before the treatment and immediately, 48 hours, 1 week, 1, 6 and 9 months after. Color change (ΔE and ΔSGU) will be performed by analysis of variance in repeated measurements. Multiple comparisons will be evaluated by Bonferroni test. Temperature variation will be evaluated by t-test in dependent groups. Tooth sensitivity will be analyzed using Friedman test. Wilcoxon test will be used to compare two light sources (Diode Laser/ LED) in each time period (p< 0.05).
- Conditions
- Color; Change Teeth, Posteruptive
- Being tested
- bleaching device
- Keywords
- In-office tooth bleaching, Diode laser, LED, color change, tooth-sensitivity, temperature
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bleaching deviceDevice
Also called whitness hp, FGM, Radii plus LED,SDI, Epic X, Biolase
activated bleaching
| Study group | Role | What they receive |
|---|---|---|
| clinician | Experimental | Comparison of LED and diode laser Receives: Device: bleaching device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colour change
Colour change will be evaluated by subjective (Vita Classic and Vita 3D Master Bleachguide) and objective methods (Vita Easy Shade, spectrophotometer).
Measured: Baseline (before the treatment) and 48 hours, 1 week, 1, 6 and 9 months after.
temperature
During the bleaching treatments, the temperature variations will be recorded using a thermocouple (DT-3891G K type Thermometer datalogger, CEM Instruments) from the buccal surface of canine teeth.
Measured: Procedure (During the bleaching treatments)
Tooth sensitivity
Tooth sensitivity will be assessed by Visual Analogue Scale (VAS).
Measured: Baseline (before the treatment) and 48 hours, 1 week, 1, 6 and 9 months after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start19 Jun 2018
- Primary completion15 Oct 2018
- Study completion5 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Color; Change Teeth, PosteruptiveStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aybuke Uslu, Hacettepe University
- Investigators
- A. Ruya Yazici, Prof., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537754
- Sponsor's protocol ID
- AUslu
- Status last verified
- Sep 2020
- First submitted
- 8 Jul 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of LED- and Diode Laser-activated Bleaching
- ClinicalTrials.gov ID
- NCT04537754
- Acronym / sponsor ID
- AUslu
- Conditions
- Color; Change Teeth, Posteruptive
- Keywords
- In-office tooth bleaching, Diode laser, LED, color change, tooth-sensitivity, temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 5 May 2019 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To clinically compare the effects of LED- or Diode laser-activated bleaching on colour change, tooth-sensitivity, gingival-irritation and temperature variation over 9-months.
Thirty-five patients with tooth colour A2 or higher will be included in the study. In a split-mouth design, using a 35% HP bleaching agent (Whiteness HP); one side of each mouth will be randomly activated by a diode laser (Epic X) and the other side by an LED (Radii Plus) light-source. During bleaching, the temperature variations will be recorded using a thermocouple from the buccal surface of canine teeth. Colour change (ΔSGU, ΔE) will be evaluated by subjective (Vita classic/bleached guide) and objective methods (spectrophotometry) before treatment and immediately, 48h, 1 week, 1, 6, 9 months after. Tooth-sensitivity and gingival- irritation will be assessed by visual analogue scale (VAS) and Gingival Index.
Detailed description
Objective: The aim of this split-mouth, randomized clinical study is to evaluate the effect of LED or Diode laser-activated bleaching applications on colour change, tooth sensitivity, gingival irritation and temperature variation with 35% hydrogen peroxide bleaching gel after 9 months. Material and Methods: Thirty-five patients with anterior teeth without caries and no restoration will be included in this study. In a split-mouth design, a bleaching agent containing 35% HP (Whiteness HP, FGM) will be used, one side of each jaw will be activated by a diode laser (Epic X, Biolase) and the other side will be activated by an LED (Radii Plus, SDI) light source. During the bleaching treatments, the temperature variations will be recorded using a thermocouple (DT-3891G K type Thermometer datalogger, CEM Instruments) from the buccal surface of canine teeth. Tooth sensitivity will be assessed by Visual Analogue Scale (VAS) before the treatment and during, immediately, 48 hours, 1 week, 1, 6 and 9 months after. Color change will be evaluated by subjective (Vita Classic and Vita 3D Master Bleachguide) and objective methods (Vita Easy Shade, spectrophotometer) before the treatment and immediately, 48 hours, 1 week, 1, 6 and 9 months after. Color change (ΔE and ΔSGU) will be performed by analysis of variance in repeated measurements. Multiple comparisons will be evaluated by Bonferroni test. Temperature variation will be evaluated by t-test in dependent groups. Tooth sensitivity will be analyzed using Friedman test. Wilcoxon test will be used to compare two light sources (Diode Laser/ LED) in each time period (p< 0.05).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clinician | Experimental | Device: bleaching deviceComparison of LED and diode laser |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy vital anterior teeth without restorations which have A2 or darker tooth shade on Vita Classical Scale (Vita Classical Scale, VITA Zahnfabrik, Bad Säckingen, Germany).
Key exclusion criteria (1 listed)
- Pregnant or lactating woman smokers Participants with periodontal diseases, tooth sensitivity internal tooth discoloration (tetracycline/ fluorosis stains), exposed engine, peroxides allergy malpositioned teeth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bleaching deviceAlso: whitness hp, FGM, Radii plus LED,SDI, Epic X, Biolaseactivated bleaching | Device | clinician |
Primary outcome
Colour change
Time frame: Baseline (before the treatment) and 48 hours, 1 week, 1, 6 and 9 months after.
Colour change will be evaluated by subjective (Vita Classic and Vita 3D Master Bleachguide) and objective methods (Vita Easy Shade, spectrophotometer).
temperature
Time frame: Procedure (During the bleaching treatments)
During the bleaching treatments, the temperature variations will be recorded using a thermocouple (DT-3891G K type Thermometer datalogger, CEM Instruments) from the buccal surface of canine teeth.
Tooth sensitivity
Time frame: Baseline (before the treatment) and 48 hours, 1 week, 1, 6 and 9 months after.
Tooth sensitivity will be assessed by Visual Analogue Scale (VAS).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. Ruya Yazici, Prof. study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bleaching device in people with Color; Change Teeth, Posteruptive, run by Hacettepe 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 1 inclusion and 1 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 4 Sep 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?
Colour change (time frame: Baseline (before the treatment) and 48 hours, 1 week, 1, 6 and 9 months after.). The study lists 3 primary outcomes in all. 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 4 Sep 2020.