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Tooth DiscolorationNCT07870317

450 nm Blue Diode Laser Versus Blue LED for In-Office Tooth Bleaching

A study testing 450 nm Blue Diode Laser, Blue Light-Emitting Diode Lamp and 35% Hydrogen Peroxide Dental Bleaching Gel in people with Tooth Discoloration, run by Misr University for Science and Technology at 1 site in Egypt.

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

Tooth discoloration is commonly managed using in-office dental bleaching. This randomized clinical trial compared the efficacy and safety of activating the same 35% hydrogen peroxide bleaching gel with either a 450 nm blue diode laser or a conventional blue light-emitting diode lamp. Read more about this study

Who is it for?
Ages 18 to 25 years
Conditions the study is for
Tooth Discoloration
What is being tested?
450 nm Blue Diode Laser, Blue Light-Emitting Diode Lamp and 35% Hydrogen Peroxide Dental Bleaching Gel
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
4 Sep 2024to 21 Apr 2025
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 25 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adults aged 18 to 25 years.
  • Male or female.
  • Medically healthy.
  • Fair oral hygiene.
  • Able and willing to cooperate with treatment and follow-up instructions.
  • No previous tooth-bleaching treatment.
Show all 10Show fewer
  • Natural maxillary and mandibular teeth extending from the right second premolar to the left second premolar.
  • No restorations involving the teeth evaluated in the study.
  • Baseline tooth shade A2 or darker according to the VITA Classical shade guide.
  • Willing to maintain a consistent pattern of consuming chromogenic foods and beverages during follow-up.

Who cannot join

  • Multiple crowns or fixed dental prostheses involving the evaluated teeth.
  • Multiple composite restorations involving the evaluated teeth.
  • Excessive alcohol or coffee intake.
  • Chronic heavy smoking.
  • Severe periodontal disease.
  • Developmental or post-eruptive enamel abnormalities, including amelogenesis imperfecta.
Show all 11Show fewer
  • Endodontically treated teeth within the treatment area.
  • Pre-existing tooth hypersensitivity.
  • Active infection at the planned bleaching site.
  • Known allergy to any component of the bleaching products.
  • Pregnancy or lactation.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Dentistry, Misr University for Science and Technology

    Giza, Giza Governorate

Other trials in Egypt

About this study

Official title: The 450 nm Blue Diode Laser Versus Blue LED in Dental Bleaching Therapy: A Double-Blind Randomized Clinical Trial

Tooth discoloration is commonly managed using in-office dental bleaching. This randomized clinical trial compared the efficacy and safety of activating the same 35% hydrogen peroxide bleaching gel with either a 450 nm blue diode laser or a conventional blue light-emitting diode lamp. Forty participants aged 18 to 25 years were randomly assigned in a 1:1 ratio to one of the two interventions. The primary outcome was postoperative tooth hypersensitivity immediately after treatment. Secondary outcomes included immediate tooth-color change, color stability at 4 weeks, 8 weeks, and 6 months, gingival irritation, and patient satisfaction. Participants and outcome assessors were blinded to group allocation, whereas the treating operator could not be blinded because the devices were visibly different.

Read the detailed description

This participant- and outcome-assessor-blinded, parallel-group randomized clinical trial evaluated two methods of photoactivating an in-office dental bleaching agent. Participants underwent medical and dental assessment and professional gingival decontamination one week before bleaching.

Participants were assigned to either a 450 nm blue diode laser group or a blue LED group. Both groups received a 35% hydrogen peroxide bleaching gel. In the laser group, the gel was activated using a TRIPLO 450 nm blue diode laser operated at 1.5 W in continuous-wave mode with an 8 mm handpiece tip for 30 seconds per tooth. Three bleaching cycles were performed, with the gel removed after each cycle. In the comparator group, the same bleaching gel was activated using the BlancOne ARCUS blue LED lamp according to the manufacturer's protocol.

Tooth color was assessed before treatment, immediately after treatment, and at 4 weeks, 8 weeks, and 6 months. Postoperative hypersensitivity was assessed immediately after treatment using a visual analogue scale. Gingival irritation and participant satisfaction were assessed using verbal rating measures. Participants, questionnaire collectors, tooth-color assessors, and the statistical analyst were blinded to group allocation. The operator administering the interventions was not blinded.

Being tested
450 nm Blue Diode Laser, Blue Light-Emitting Diode Lamp, 35% Hydrogen Peroxide Dental Bleaching Gel
Keywords
Dental bleaching, Tooth whitening, 450 nm blue diode laser, Blue light-emitting diode, Tooth hypersensitivity, Color stability
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.

  • 450 nm Blue Diode LaserDevice

    Also called TRIPLO, Medency

    A 450 nm blue diode laser was used to activate the dental bleaching gel. The device was operated at 1.5 W in continuous-wave mode using a therapy handpiece with an 8 mm tip connected to an optical fiber. Irradiation was delivered for 30 seconds per tooth. Three bleaching cycles were performed.

  • Blue Light-Emitting Diode LampDevice

    Also called BlancOne ARCUS

    A blue light-emitting diode lamp was used to activate the dental bleaching gel. The device was operated according to the manufacturer's recommended protocol, The lamp was oriented perpendicularly to the teeth at a distance of 5-10 cm from the mouth to guarantee adequate airflow. The bleaching session consisted of three cycles. The gel was photoactivated for 8 minutes during each cycle.

  • 35% Hydrogen Peroxide Dental Bleaching GelDrug

    Also called BlancOne ULTRA+

    The same 35% hydrogen peroxide dental bleaching gel was applied in both study arms. The bleaching session consisted of three cycles. The gel was photoactivated for 8 minutes during each cycle.

Study groups in NCT07870317
Study groupRoleWhat they receive
450 nm Blue Diode Laser ActivationExperimentalParticipants underwent in-office tooth bleaching with 35% hydrogen peroxide gel activated using a 450 nm blue diode laser. The laser was operated at 1.5 W in continuous-wave mode through an 8 mm handpiece tip for 30 seconds per tooth. Three bleaching cycles were performed, with the gel removed after each cycle.
Receives: Device: 450 nm Blue Diode Laser; Drug: 35% Hydrogen Peroxide Dental Bleaching Gel
Blue LED ActivationActive comparatorParticipants underwent in-office tooth bleaching with the same 35% hydrogen peroxide gel activated using a blue LED lamp according to the manufacturer's recommended protocol. The LED was placed at 5-10cm from the mouth for a period of 24 minutes. The bleaching gel was simultaneously activated on both arches, including the sides, without any operator intervention. The bleaching session consisted of three cycles. The gel was photoactivated for 8 minutes during each cycle.
Receives: Device: Blue Light-Emitting Diode Lamp; Drug: 35% Hydrogen Peroxide Dental Bleaching Gel

What is being measured

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

  1. Postoperative Tooth Hypersensitivity Assessed Using a Visual Analogue Scale

    Participants rated tooth hypersensitivity using a visual analogue scale. The VAS outlines six The patients were asked to select the option that most accurately reflects their amount of discomfort or pain experienced. The scores of 0 (no pain), 1(little), 2 (mild), 3 (moderate), 4 (severe), 5 (very severe), and 6 (unbearable) were sequentially awarded to each face, representing an increasing level of pain.

    Measured: Immediately after completion of the in-office bleaching session.

Secondary outcomes (5)
  1. Change From Baseline in Visual Tooth Shade Immediately After Bleaching

    Tooth shade was assessed using the VITA Bleachedguide 3D-Master® classic guide. Shade tabs were converted into ordered numerical shade units. The change from baseline to immediately after treatment was calculated, with a greater reduction in shade units indicating greater whitening.

    Measured: Tooth color assessments were conducted at baseline, immediately post-bleaching treatment.

  2. Spectrophotometric Tooth Color Change Immediately After Bleaching

    Tooth color was measured using a spectrophotometer at baseline and immediately after treatment. Color difference was calculated using the metric ΔE*ab, ΔE00. Higher values indicated a greater color difference from baseline.

    Measured: Baseline and immediately after the bleaching session.

  3. Tooth Color Stability During the Six-Month Follow-Up

    Tooth shade was assessed immediately after treatment and at 4 weeks, 8 weeks, and 6 months. Shade regression was calculated as the change between the immediate post-treatment shade and each follow-up measurement. Greater shade regression indicated greater loss of the whitening effect.

    Measured: Immediately after treatment and at 4 weeks, 8 weeks, and 6 months.

  4. Spectrophotometric Color Stability During Follow-Up

    Spectrophotometric tooth-color measurements were obtained immediately after treatment and at 4 weeks, 8 weeks, and 6 months. Color stability was assessed by calculating the change in spectrophotometric shade scores between successive assessment periods. Greater positive changes during follow-up indicated greater shade regression and loss of the whitening effect.

    Measured: Immediately after treatment and at 4 weeks, 8 weeks, and 6 months.

  5. Participant Satisfaction With the Bleaching Treatment

    Participants rated their overall satisfaction using a verbal rating scale with the following scores: 1 for extremely satisfied, 2 for satisfied, 3 not satisfied.

    Measured: At the end of follow-up, 6 months after treatment.

Timeline

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

  1. First posted13 Oct 2026
  2. Study start4 Sep 2024
  3. Primary completion21 Oct 2024
  4. Study completion21 Apr 2025

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
Randomised
Intervention model
Parallel groups
Model description
Participants were randomly assigned in a 1:1 ratio to receive in-office dental bleaching activated by either a 450 nm blue diode laser or a blue LED lamp. Each participant remained in the assigned treatment arm for the duration of the study.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07870317
Sponsor's protocol ID
MUST-BLEACH-450-01
Other IDs
2024/0025
Status last verified
Oct 2026
First submitted
6 Oct 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Goldberg M, Grootveld M, Lynch E. Undesirable and adverse effects of tooth-whitening products: a review. Clin Oral Investig. 2010 Feb;14(1):1-10. doi: 10.1007/s00784-009-0302-4. Epub 2009 Jun 20.

    PubMed 19543926
  • Gottenbos B, de Witz C, Heintzmann S, Born M, Hotzl S. Insights into blue light accelerated tooth whitening. Heliyon. 2021 Feb 10;7(2):e05913. doi: 10.1016/j.heliyon.2021.e05913. eCollection 2021 Feb.

    PubMed 33615002
  • Saberi S, Rouzsaz M, Shafie F, Einizadeh S, Kharazifard MJ, Shahabi S. The effect of laser-activated bleaching with 445 nm and 915 nm diode lasers on enamel micro-hardness; an in vitro study. Photodiagnosis Photodyn Ther. 2020 Sep;31:101952. doi: 10.1016/j.pdpdt.2020.101952. Epub 2020 Aug 18.

    PubMed 32818641
  • Drost T, Reimann S, Frentzen M, Meister J. Effectiveness of photopolymerization in composite resins using a novel 445-nm diode laser in comparison to LED and halogen bulb technology. Lasers Med Sci. 2019 Jun;34(4):729-736. doi: 10.1007/s10103-018-2651-1. Epub 2018 Oct 6.

    PubMed 30291465
  • Katalinic I, Budimir A, Bosnjak Z, Jakovljevic S, Anic I. The photo-activated and photo-thermal effect of the 445/970 nm diode laser on the mixed biofilm inside root canals of human teeth in vitro: A pilot study. Photodiagnosis Photodyn Ther. 2019 Jun;26:277-283. doi: 10.1016/j.pdpdt.2019.04.014. Epub 2019 Apr 14.

    PubMed 30995521
  • Al-Maliky MA, Frentzen M, Meister J. Artificial Caries Resistance in Enamel after Topical Fluoride Treatment and 445 nm Laser Irradiation. Biomed Res Int. 2019 Nov 3;2019:9101642. doi: 10.1155/2019/9101642. eCollection 2019.

    PubMed 31781651
  • De Moor RJ, Verheyen J, Verheyen P, Diachuk A, Meire MA, De Coster PJ, De Bruyne M, Keulemans F. Laser teeth bleaching: evaluation of eventual side effects on enamel and the pulp and the efficiency in vitro and in vivo. ScientificWorldJournal. 2015;2015:835405. doi: 10.1155/2015/835405. Epub 2015 Mar 22.

    PubMed 25874258
  • Buchalla W, Attin T. External bleaching therapy with activation by heat, light or laser--a systematic review. Dent Mater. 2007 May;23(5):586-96. doi: 10.1016/j.dental.2006.03.018. Epub 2006 Jul 3.

    PubMed 16820199
  • Fekrazad R, Alimazandarani S, Kalhori KA, Assadian H, Mirmohammadi SM. Comparison of laser and power bleaching techniques in tooth color change. J Clin Exp Dent. 2017 Apr 1;9(4):e511-e515. doi: 10.4317/jced.53435. eCollection 2017 Apr.

    PubMed 28469814
  • Joiner A. The bleaching of teeth: a review of the literature. J Dent. 2006 Aug;34(7):412-9. doi: 10.1016/j.jdent.2006.02.002. Epub 2006 Mar 29.

    PubMed 16569473
  • Haywood VB, Heymann HO. Nightguard vital bleaching: how safe is it? Quintessence Int. 1991 Jul;22(7):515-23.

    PubMed 1882044
  • Tooth whitening/bleaching: treatment considerations for dentists and their patients. ADA Council on Scientific Affairs. Sept 2009 (revised Nov 2010), p. 1-12.

Questions about this trial

What is this clinical trial studying?

A study testing 450 nm Blue Diode Laser, Blue Light-Emitting Diode Lamp and 35% Hydrogen Peroxide Dental Bleaching Gel in people with Tooth Discoloration, run by Misr University for Science and Technology at 1 site in Egypt.

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 10 inclusion and 11 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 13 Oct 2026. 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 Egypt. 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?

Postoperative Tooth Hypersensitivity Assessed Using a Visual Analogue Scale (time frame: Immediately after completion of the in-office bleaching session.). 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 NCT07870317, which also lists 12 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 13 Oct 2026.

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