NCT07870317|Completed
450 nm Blue Diode Laser Versus Blue LED for In-Office Tooth Bleaching
The 450 nm Blue Diode Laser Versus Blue LED in Dental Bleaching Therapy: A Double-Blind Randomized Clinical Trial
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The 450 nm Blue Diode Laser Versus Blue LED in Dental Bleaching Therapy: A Double-Blind Randomized Clinical Trial
Sponsor study identifier
Secondary identifiers
OTHER · Misr University for Science and Technology
interventional
40
1 country
1
Study Start
September 4, 2024
Actual (reported)Primary Completion
October 21, 2024
Actual (reported)Study Completion
April 21, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 21, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 4, 2024
Actual (reported)October 21, 2024
Actual (reported)April 21, 2025
Actual (reported)October 6, 2026
Actual (reported)October 13, 2026
Actual (reported)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.
Immediately after completion of the in-office bleaching session.
Change From Baseline in Visual Tooth Shade Immediately After Bleaching
Tooth color assessments were conducted at baseline, immediately post-bleaching treatment.
Spectrophotometric Tooth Color Change Immediately After Bleaching
Baseline and immediately after the bleaching session.
Tooth Color Stability During the Six-Month Follow-Up
Immediately after treatment and at 4 weeks, 8 weeks, and 6 months.
Spectrophotometric Color Stability During Follow-Up
Immediately after treatment and at 4 weeks, 8 weeks, and 6 months.
Participant Satisfaction With the Bleaching Treatment
At the end of follow-up, 6 months after treatment.
Participants 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.
Participants 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.
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.
Faculty of Dentistry, Misr University for Science and Technology
Giza, Giza Governorate, Egypt
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.
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.
Shahd A ElHadidy, BDS
Misr University for Science and Technology
40 participants (actual enrollment reported by the registry).
First Submitted
October 6, 2026
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.
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.
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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.
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.
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.
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.
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.
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.
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.
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.
Haywood VB, Heymann HO. Nightguard vital bleaching: how safe is it? Quintessence Int. 1991 Jul;22(7):515-23.
Tooth whitening/bleaching: treatment considerations for dentists and their patients. ADA Council on Scientific Affairs. Sept 2009 (revised Nov 2010), p. 1-12.
First Posted
October 13, 2026
Study Start
September 4, 2024
Actual (reported)Primary Completion
October 21, 2024
Actual (reported)Study Completion
April 21, 2025
Actual (reported)Last Updated
October 13, 2026
Record last verified: 2026-10
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