Bleaching; SatisfactoryNCT07493941
Effect of Bleaching Regimen With Different Activation Modes on Color Stability, Surface Roughness, Tooth Sensitivity and Patient Satisfaction
A study testing 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with Laser Activation, 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with LED/Light Activation and 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) - Chemical Activation Only in people with Bleaching; Satisfactory and Bleaching Sensitivity, run by Tanta University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Bleaching; Satisfactory, Bleaching Sensitivity, Bleaching Efficacy
- What is being tested?
- 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with Laser Activation, 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with LED/Light Activation and 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) - Chemical Activation Only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 3 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Teeth with caries, cracks, hypersensitivity, restorations, veneers, or crowns in the anterior region
- Pregnant or lactating women
- Smoking or use of tobacco products
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Restorative Department, Faculty of Dentistry, Tanta University
Tanta, Tanta, 31527
About this study
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.
- Being tested
- 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with Laser Activation, 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with LED/Light Activation, 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) - Chemical Activation Only
- Keywords
- Bleaching, Color Stability, Tooth Sensitivity, Surface Roughness
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with Laser ActivationOther
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
35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with LED/Light ActivationOther
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.
35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) - Chemical Activation OnlyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Laser-Activated In-Office Bleaching | Experimental | Participants receive in-office bleaching using 35% hydrogen peroxide activated by a dental laser system. Receives: Other: 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with Laser Activation |
| Light-Activated In-Office Bleaching | Experimental | Participants receive in-office bleaching using 35% hydrogen peroxide activated by a visible light source Receives: Other: 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with LED/Light Activation |
| Chemically Activated In-Office Bleaching (Control) | Active comparator | Participants receive in-office bleaching using 35% hydrogen peroxide without any external activation. Receives: Other: 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) - Chemical Activation Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-bleaching), immediately post-bleaching, 1 month, and 3 months post-treatment
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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
Measured: Immediately after treatment and at 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jan 2026
- Primary completion2 Jul 2026 (estimated)
- Study completion3 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bleaching; SatisfactoryStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abd El Ghany Mohammed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493941
- Sponsor's protocol ID
- Dental Bleaching
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 35976497Atay 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 41340117Alkhuzaie 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 40375839Jiang 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 38303586Kurucu 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bleaching Regimen With Different Activation Modes on Color Stability, Surface Roughness, Tooth Sensitivity and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT07493941
- Acronym / sponsor ID
- Dental Bleaching
- Keywords
- Bleaching, Color Stability, Tooth Sensitivity, Surface Roughness
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 2 Jul 2026 (estimated)
- Study completion
- 3 Jul 2026 (estimated)
- First posted
- 27 Mar 2026 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laser-Activated In-Office Bleaching | Experimental | Other: 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with Laser ActivationParticipants receive in-office bleaching using 35% hydrogen peroxide activated by a dental laser system. |
| Light-Activated In-Office Bleaching | Experimental | Other: 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with LED/Light ActivationParticipants receive in-office bleaching using 35% hydrogen peroxide activated by a visible light source |
| Chemically Activated In-Office Bleaching (Control) | Active comparator | Other: 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) - Chemical Activation OnlyParticipants receive in-office bleaching using 35% hydrogen peroxide without any external activation. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Teeth with caries, cracks, hypersensitivity, restorations, veneers, or crowns in the anterior region
- Pregnant or lactating women
- Smoking or use of tobacco products
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 |
|---|---|---|
| 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with Laser ActivationApplication 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 | Other | Laser-Activated In-Office Bleaching |
| 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with LED/Light ActivationApplication 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. | Other | Light-Activated In-Office Bleaching |
| 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) - Chemical Activation OnlyApplication 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. | Other | Chemically Activated In-Office Bleaching (Control) |
Primary outcome
Color Change (ΔE)
Time frame: Baseline (pre-bleaching), immediately post-bleaching, 1 month, and 3 months post-treatment
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.
3 secondary outcomes
Enamel Surface Roughness (Ra, µm)
Time frame: Baseline and immediately after bleaching procedure
Tooth Sensitivity
Time frame: Immediately after bleaching, 24 hours post-treatment, and up to 7 days post-treatment
Patient Satisfaction
Time frame: Immediately after treatment and at 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Results publication: PubMed 35976497Pereira 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.
- Results publication: PubMed 41340117Atay 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.
- Results publication: PubMed 40375839Alkhuzaie 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.
- Results publication: PubMed 38303586Jiang 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.
- Results publication: PubMed 41387842Kurucu 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.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with Laser Activation, 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) with LED/Light Activation and 35% Hydrogen Peroxide Bleaching Gel (Bleach 'n Smile®, Schutz Dental, Germany) - Chemical Activation Only in people with Bleaching; Satisfactory and Bleaching Sensitivity, run by Tanta University 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 4 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 29 Jun 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?
This study is still under way. Results are not available in the source record yet.
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?
Color Change (ΔE) (time frame: Baseline (pre-bleaching), immediately post-bleaching, 1 month, and 3 months post-treatment). 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 NCT07493941, which also lists 5 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 29 Jun 2026.