An interventional study of 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with Laser Activation and 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with LED/Light Activation in Bleaching; Satisfactory, Bleaching Sensitivity and Bleaching Efficacy, sponsored by Tanta University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
The purpose of this study was to conduct a randomized double-blind clinical trial to examine the efficacy of an in-office bleaching regimen with varied activation modes on color stability, surface roughness, tooth sensitivity, and patient satisfaction.
Tooth discoloration is a common esthetic concern that can negatively impact patients' self-confidence and quality of life. Contemporary restorative dentistry increasingly emphasizes minimally invasive approaches, with vital tooth bleaching emerging as a widely accepted, conservative treatment for managing extrinsic and intrinsic discoloration. The effectiveness of bleaching procedures primarily depends on the oxidative degradation of chromogenic compounds within dental hard tissues, leading to improved tooth color.
In-office bleaching techniques often incorporate various activation modes intended to enhance the efficacy of bleaching agents, accelerate treatment time, and improve clinical outcomes. These activation methods may include light-emitting diode (LED) systems, laser activation, or purely chemical activation without external energy sources. Despite their widespread use, the actual benefit of these activation modalities remains controversial, with conflicting evidence regarding their influence on bleaching effectiveness and associated adverse effects.
288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.
This study's planned enrollment of 45 is below the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.
Browse Dentin Sensitivity studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive in-office bleaching using 35% hydrogen peroxide activated by a dental laser system.
Other: 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with Laser Activation
Participants receive in-office bleaching using 35% hydrogen peroxide activated by a visible light source
Other: 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with LED/Light Activation
Participants receive in-office bleaching using 35% hydrogen peroxide without any external activation.
Other: 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) - Chemical Activation Only
Application of a 35% hydrogen peroxide bleaching agent (Bleach 'n Smile®) to the labial tooth surfaces, followed by activation using a dental laser according to the manufacturer's recommended parameters. The bleaching procedure is performed in a single clinical session under standardized conditions
Application of a 35% hydrogen peroxide bleaching agent (Bleach 'n Smile®) followed by activation using a dental light-curing unit or LED-based bleaching system, according to manufacturer instructions.
Application of 35% hydrogen peroxide bleaching agent (Bleach 'n Smile®) without the use of external energy sources, allowing the material to act chemically according to manufacturer instructions.
Color Change (ΔE)
Assessment of tooth color change using a digital spectrophotometer (VITA Easyshade® V, Vita Zahnfabrik, Germany). Color measurements will be recorded in the CIE L\*a\*b\* color space, and the overall color difference (ΔE) will be calculated between baseline and subsequent time points.
Time frame: Baseline (pre-bleaching), immediately post-bleaching, 1 month, and 3 months post-treatment
Enamel Surface Roughness (Ra, µm)
Evaluation of changes in enamel surface roughness following bleaching procedures. A profilometer used to record average surface roughness (Ra) values in micrometers (µm)
Time frame: Baseline and immediately after bleaching procedure
Tooth Sensitivity
Assessment of patient-reported tooth sensitivity associated with bleaching procedures. Visual Analog Scale (VAS) ranging from 0 (no sensitivity) to 10 (maximum unbearable sensitivity)
Time frame: Immediately after bleaching, 24 hours post-treatment, and up to 7 days post-treatment
Patient Satisfaction
Evaluation of patient satisfaction regarding esthetic outcomes and overall treatment experience. Validated questionnaire using a Likert scale (e.g., 1 = very dissatisfied to 5 = very satisfied), covering aspects such as perceived color improvement, comfort, and willingness to undergo the procedure again
Time frame: Immediately after treatment and at 3-month follow-up
Plan to share: No
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