ClinicalTrials.gg
Enrolling by invitationNCT07493941Updated Jun 29, 2026

Effect of Bleaching Regimen With Different Activation Modes on Color Stability, Surface Roughness, Tooth Sensitivity and Patient Satisfaction

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

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 33 studies in Dentin Sensitivity with a site in Egypt — 6 open to participants now, 8 under way, 1 of them phase 3. Dentin Sensitivity · Egypt.

Planned enrollment
19th of 32
45 · median 48
Started
2026
with 1 other
No phase
24 of 33
5 open now
Registered
30th of 33
by date
Lead sponsor
2 of 33
Tanta University

Among the 33 studies in Dentin Sensitivity with a site in Egypt, this one is the 19th largest by planned enrollment of the 32 interventional ones that give a count, is one of 2 that started in 2026, is one of 24 with no phase, and was the 30th registered.

Dentin Sensitivity

288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.

Browse Dentin Sensitivity studies →

Open to participants now

6 of the 33 studies in Dentin Sensitivity with a site in Egypt are open now. Recruiting first, the newest first:

All 6 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 18 Dentin Sensitivity studies recruiting now, 6 (33%) set no upper age limit and 11 (61%) stop at 75 or younger; 1 take children under 18; 11 take healthy volunteers.

This study: 20 Years to 35 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 33 studies in Dentin Sensitivity with a site in Egypt, or all of them as a file.
02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Bleaching; Satisfactory
  • Bleaching Sensitivity
  • Bleaching Efficacy

Browse trials for

Keywords

  • Bleaching
  • Color Stability
  • Tooth Sensitivity
  • Surface Roughness
04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 20-35 years
  • Individuals seeking esthetic improvement through tooth bleaching
  • Good general and oral health, with no active periodontal disease
  • Normal vital teeth (confirmed by clinical examination)

Exclusion criteria

Exclusion Criteria:

  • Teeth with caries, cracks, , restorations, veneers, or crowns in the anterior region
  • Pregnant or lactating women
  • Smoking or use of tobacco products
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Laser-Activated In-Office Bleaching

    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

  • Experimental
    Light-Activated In-Office Bleaching

    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

  • Active comparator
    Chemically Activated In-Office Bleaching (Control)

    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

Interventions

  • Other35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with Laser Activation

    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

  • Other35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with LED/Light Activation

    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.

  • Other35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) - Chemical Activation Only

    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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

1 site
08

References and documents

Publications

  • Pereira R, Silveira J, Dias S, Cardoso A, Mata A, Marques D. Bleaching efficacy and quality of life of different bleaching techniques - randomized controlled trial. Clin Oral Investig. 2022 Dec;26(12):7167-7177. doi: 10.1007/s00784-022-04678-5. Epub 2022 Aug 17. PubMed 35976497 ↗
  • Atay A, Canpolat D, Sismanoglu S, Usumez A. Comparative evaluation of different bleaching agents on the color stability, hardness and surface roughness of indirect esthetic restorative materials with different manufacturing methods. BMC Oral Health. 2025 Dec 4;26(1):36. doi: 10.1186/s12903-025-07355-7. PubMed 41340117 ↗
  • Alkhuzaie AI, Elawsya ME, Elkholany NR. Impact of Different Bleaching Methods on Surface Roughness, Microhardness, and Tooth-Restoration Interface of Ormocer- and Methacrylate-based Restorative Systems. J Clin Exp Dent. 2025 Apr 1;17(4):e422-e431. doi: 10.4317/jced.62614. eCollection 2025 Apr. PubMed 40375839 ↗
  • Jiang NW, Cheng YL, Huang HL, Zhong BJ, Bi W, Yu H. Correlation between patient satisfaction and color changes after tooth bleaching. J Esthet Restor Dent. 2024 Mar;36(3):437-444. doi: 10.1111/jerd.13200. Epub 2024 Feb 1. PubMed 38303586 ↗
  • Kurucu Karadeniz BK. Effects of different bleaching methods on the color stability, microhardness, and surface roughness of single-shade composites. BMC Oral Health. 2025 Dec 12;25(1):1895. doi: 10.1186/s12903-025-07147-z. PubMed 41387842 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Jul 2026, 6 months after the start.

Of 111 non-industry interventional studies with no phase under Dentin Sensitivity, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 12. This study's planned 6 months is below that.

Counting every sponsor, half of 144 studies reached it within 6 months; a quarter within 3 and three quarters within 10.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2026
First posted
Mar 27, 2026
StartActual
Jan 1, 2026
Primary completionEst.
Jul 2, 2026
CompletionEst.
Jul 3, 2026
Last update
Jun 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07493941
Lead sponsor
Tanta University
Responsible party
Mohammed Abd El Ghany Mohammed (Principal Investigator, Tanta University) — Principal investigator
First posted
Mar 27, 2026
Start date
Jan 1, 2026
Primary completion
Jul 2, 2026 (estimated)
Completion
Jul 3, 2026 (estimated)
Last update
Jun 29, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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