Tooth DiscolorationBECTSNCT07818031
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
A study testing peroxide -based in office tooth bleaching and non-peroxide -based in office tooth bleaching in people with Tooth Discoloration and Tooth Staining, run by Minia University at 1 site in Egypt.
Trial summary
This randomized clinical trial aims to compare the effectiveness of peroxide and non-peroxide in-office tooth bleaching systems. The study will evaluate tooth whitening efficacy, color durability over time, and tooth sensitivity after treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration, Tooth Staining
- What is being tested?
- peroxide -based in office tooth bleaching and non-peroxide -based in office tooth bleaching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2026to 15 Mar 2027
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-45 years.
- Good general health.
- Presence of all maxillary anterior teeth free from restorations, caries, or structural defects.
- Baseline tooth shade suitable for bleaching assessment.
- Good oral hygiene and periodontal health.
- Willingness to comply with the study protocol and attend all follow-up visits.
- Signed informed consent.
Who cannot join
- Pregnancy or lactation.
- History of tooth hypersensitivity.
- Active caries or defective restorations in the anterior teeth.
- Intrinsic tooth discoloration (e.g., fluorosis, tetracycline staining).
- Ongoing orthodontic treatment.
- Smoking.
- Use of tooth-whitening products within the previous 6 months.
- Allergy to any component of the bleaching materials.
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, 1 recruiting
- Recruiting
Minia University Hospital
Minya, Minya Governorate
Esraa Eid, MSc, +20 1019243773, esraa.korny@nub.edu
About this study
Official title: Bleaching Efficacy, Color Durability, and Tooth Sensitivity After In-Office Bleaching With Peroxide Versus Non-Peroxide Systems: A Randomized Clinical Trial
This randomized clinical trial aims to compare the effectiveness of peroxide and non-peroxide in-office tooth bleaching systems. The study will evaluate tooth whitening efficacy, color durability over time, and tooth sensitivity after treatment. Participants will receive one of the two bleaching treatments and will be followed for six months to assess the clinical outcomes and compare the performance of both systems.
Read the detailed description
This randomized controlled clinical trial is designed to compare the clinical performance of peroxide-based and non-peroxide in-office tooth bleaching systems. Eligible participants will be randomly allocated into two treatment groups. Tooth color will be assessed using standardized clinical evaluation methods before treatment, immediately after bleaching, and during follow-up visits. The study will also evaluate color stability and tooth sensitivity over a six-month follow-up period. The findings are expected to provide evidence regarding the effectiveness and safety of both bleaching systems and to support evidence-based clinical decision-making in esthetic dentistry.
- Conditions
- Tooth Discoloration, Tooth Staining
- Being tested
- peroxide -based in office tooth bleaching, non-peroxide -based in office tooth bleaching
- Keywords
- Bleaching, Color, Sensitivity, In-Office, Peroxide, Non-Peroxide
- Medical subject headings
- Tooth Discoloration, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peroxide -based in office tooth bleachingProcedure or surgery
Participants will receive an in-office peroxide-based tooth bleaching treatment using the bleaching system according to the manufacturer's instructions.
non-peroxide -based in office tooth bleachingProcedure or surgery
Participants will receive an in-office non- peroxide-based tooth bleaching treatment using the bleaching system according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Peroxide-based in office bleaching | Experimental | Participants will receive a peroxide-based in-office tooth bleaching treatment according to the manufacturer's instructions. Receives: Procedure: peroxide -based in office tooth bleaching |
| Non-peroxide-based in office bleaching | Experimental | Participants will receive a non-peroxide-based in-office tooth bleaching treatment according to the manufacturer's instructions. Receives: Procedure: non-peroxide -based in office tooth bleaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleaching efficacy measured by Whiteness Index for Dentistry (WID)
Bleaching efficacy will be assessed using the Whiteness Index for Dentistry (WID), obtained by spectrophotometric measurement of the anterior teeth at baseline, immediately after treatment, and at 1, 3, and 6 months after treatment. The change in WID (ΔWID) from baseline will be calculated at each post-treatment time point. Higher WID values indicate greater tooth whiteness.
Measured: Baseline, immediately after treatment, 1 month, 3 months, and 6 months after treatment
Color durability measured by CIEDE2000 color difference (ΔE00)
Color durability will be evaluated using spectrophotometric measurements and the CIEDE2000 color difference formula (ΔE₀₀), a standardized method developed by the International Commission on Illumination (CIE) to quantify color differences. Color differences between the immediate post-treatment measurement and each follow-up measurement at 1, 3, and 6 months will be calculated. A ΔE₀₀ value of 0 indicates no color difference, whereas higher values indicate greater color difference from the immediate post-treatment color.
Measured: Baseline, immediately after treatment, 1 month, 3 months, and 6 months after treatment
Tooth sensitivity assessed using the Visual Analog Scale (VAS)
Tooth sensitivity will be assessed using a 0-10 Visual Analog Scale (VAS), with a minimum score of 0 indicating no pain and a maximum score of 10 indicating the worst possible pain. Higher scores indicate greater tooth sensitivity and pain.
Measured: Daily during the 14-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start15 Aug 2026
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiscolorationStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomly assigned to one of two parallel groups. One group will receive a peroxide-based in-office tooth bleaching treatment, and the other group will receive a non-peroxide in-office tooth bleaching treatment. Clinical outcomes will be evaluated and compared over a six-month follow-up period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Eid Qurany, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818031
- Sponsor's protocol ID
- MU-1301-2026
- Other IDs
- 1301/2026
- Acronym
- BECTS
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be shared because there is no plan for public data sharing beyond the analyses and results reported in the study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleaching Efficacy, Color Durability, and Tooth Sensitivity After In-Office Bleaching With Peroxide Versus Non-Peroxide Systems: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07818031
- Acronym / sponsor ID
- BECTS / MU-1301-2026
- Conditions
- Tooth Discoloration, Tooth Staining
- Keywords
- Bleaching, Color, Sensitivity, In-Office, Peroxide, Non-Peroxide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 14 Sep 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.
This randomized clinical trial aims to compare the effectiveness of peroxide and non-peroxide in-office tooth bleaching systems. The study will evaluate tooth whitening efficacy, color durability over time, and tooth sensitivity after treatment. Participants will receive one of the two bleaching treatments and will be followed for six months to assess the clinical outcomes and compare the performance of both systems.
Detailed description
This randomized controlled clinical trial is designed to compare the clinical performance of peroxide-based and non-peroxide in-office tooth bleaching systems. Eligible participants will be randomly allocated into two treatment groups. Tooth color will be assessed using standardized clinical evaluation methods before treatment, immediately after bleaching, and during follow-up visits. The study will also evaluate color stability and tooth sensitivity over a six-month follow-up period. The findings are expected to provide evidence regarding the effectiveness and safety of both bleaching systems and to support evidence-based clinical decision-making in esthetic dentistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. One group will receive a peroxide-based in-office tooth bleaching treatment, and the other group will receive a non-peroxide in-office tooth bleaching treatment. Clinical outcomes will be evaluated and compared over a six-month follow-up period.
| Arm | Type | Receives |
|---|---|---|
| Peroxide-based in office bleaching | Experimental | Procedure: peroxide -based in office tooth bleachingParticipants will receive a peroxide-based in-office tooth bleaching treatment according to the manufacturer's instructions. |
| Non-peroxide-based in office bleaching | Experimental | Procedure: non-peroxide -based in office tooth bleachingParticipants will receive a non-peroxide-based in-office tooth bleaching treatment according to the manufacturer's instructions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults aged 18-45 years.
- Good general health.
- Presence of all maxillary anterior teeth free from restorations, caries, or structural defects.
- Baseline tooth shade suitable for bleaching assessment.
- Good oral hygiene and periodontal health.
Key exclusion criteria (8 listed)
- Pregnancy or lactation.
- History of tooth hypersensitivity.
- Active caries or defective restorations in the anterior teeth.
- Intrinsic tooth discoloration (e.g., fluorosis, tetracycline staining).
- Ongoing orthodontic treatment.
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 |
|---|---|---|
| peroxide -based in office tooth bleachingParticipants will receive an in-office peroxide-based tooth bleaching treatment using the bleaching system according to the manufacturer's instructions. | Procedure or surgery | Peroxide-based in office bleaching |
| non-peroxide -based in office tooth bleachingParticipants will receive an in-office non- peroxide-based tooth bleaching treatment using the bleaching system according to the manufacturer's instructions. | Procedure or surgery | Non-peroxide-based in office bleaching |
Primary outcome
Bleaching efficacy measured by Whiteness Index for Dentistry (WID)
Time frame: Baseline, immediately after treatment, 1 month, 3 months, and 6 months after treatment
Bleaching efficacy will be assessed using the Whiteness Index for Dentistry (WID), obtained by spectrophotometric measurement of the anterior teeth at baseline, immediately after treatment, and at 1, 3, and 6 months after treatment. The change in WID (ΔWID) from baseline will be calculated at each post-treatment time point. Higher WID values indicate greater tooth whiteness.
Color durability measured by CIEDE2000 color difference (ΔE00)
Time frame: Baseline, immediately after treatment, 1 month, 3 months, and 6 months after treatment
Color durability will be evaluated using spectrophotometric measurements and the CIEDE2000 color difference formula (ΔE₀₀), a standardized method developed by the International Commission on Illumination (CIE) to quantify color differences. Color differences between the immediate post-treatment measurement and each follow-up measurement at 1, 3, and 6 months will be calculated. A ΔE₀₀ value of 0 indicates no color difference, whereas higher values indicate greater color difference from the immediate post-treatment color.
Tooth sensitivity assessed using the Visual Analog Scale (VAS)
Time frame: Daily during the 14-day treatment period
Tooth sensitivity will be assessed using a 0-10 Visual Analog Scale (VAS), with a minimum score of 0 indicating no pain and a maximum score of 10 indicating the worst possible pain. Higher scores indicate greater tooth sensitivity and pain.
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 15 Oct 2026.
- Individual participant dataSharing planned: No. individual participant data will not be shared because there is no plan for public data sharing beyond the analyses and results reported in the study.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peroxide -based in office tooth bleaching and non-peroxide -based in office tooth bleaching in people with Tooth Discoloration and Tooth Staining, run by Minia 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 15 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?
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?
Contact Esraa Eid, MSc (+20 1019243773, esraa.korny@nub.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleaching efficacy measured by Whiteness Index for Dentistry (WID) (time frame: Baseline, immediately after treatment, 1 month, 3 months, and 6 months after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.