Tooth DiscolorationPhase 1NCT06782087
A Comparative Study Between the Efficacy of Diode Laser and Nano-chitosan Gel on Activation of Non-vital in- Office Bleaching Agent
A Phase 1 study testing nano chitosan in people with Tooth Discoloration, run by Misr University for Science and Technology at 1 site in Egypt.
Trial summary
The growing demand for white smile between patients has increased over recent years, the development of techniques and improvement of materials permits searching for beautiful natural smile. The discoloration of teeth might be intrinsic, extrinsic, or combined. A variety of commercial bleaching agents is available. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- nano chitosan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2025to 30 Oct 2025
- Phase
- Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- discolored crown, non-vital or endodontically treated upper central and lateral incisors
- previous endodontic treatment performed two or more years earlier.
Who cannot join
- caries on upper central and lateral incisors, inadequate fillings, and progressive periodontal disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Comparative Study Between the Efficacy of Diode Laser and Nano-chitosan Gel on Activation of Non-vital in- Office Bleaching Agent :A Controlled Clinical Trial
The growing demand for white smile between patients has increased over recent years, the development of techniques and improvement of materials permits searching for beautiful natural smile.
The discoloration of teeth might be intrinsic, extrinsic, or combined. A variety of commercial bleaching agents is available. The most common substances used are carbamide peroxide or hydrogen peroxide or a mixture of sodium perborate and hydrogen peroxide.
Read the detailed description
The aim of the study is to assess the effectiveness of two different in-office bleaching materials carbamide peroxide alone and carbamide peroxide with Chitosan nanoparticles Using diode laser as an activator Regarding tooth whitening and color stability 1 Day , 1 weeks, 1 month after treatment using Vita easy shade.
- Conditions
- Tooth Discoloration
- Being tested
- nano chitosan
- Keywords
- chitosan nanoparticles, Diode laser, carbamide peroxide, nonvital teeth bleaching
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nano chitosanDrug
nano chitosan
| Study group | Role | What they receive |
|---|---|---|
| peroxides and sodium perborate and 980nm diode laser. | Other | peroxides and sodium perborate + 980nm diode laser. Receives: Drug: nano chitosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color change
these assessments were performed for 1 day, 1 week, and 1 month after treatment with Vita easy shade obtaining difference ∆E* values using colorcoordinates CIE L*, a* and b*
Measured: these assessments were performed for 1 day, 1 week, and 1 month after treatment with Vita easy shade.
color change using digital vita easy shade guide
color change using digital vita easy shade guide
Measured: 1 day , 1 week , 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start15 Oct 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Sabry, Misr University for Science and Technology
- Investigators
- Manal abd el baky A dr, phd, Study director, Lecturer in conservative surgery departement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782087
- Sponsor's protocol ID
- 2022/0037
- Status last verified
- May 2025
- First submitted
- 23 Dec 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between the Efficacy of Diode Laser and Nano-chitosan Gel on Activation of Non-vital in- Office Bleaching Agent :A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06782087
- Acronym / sponsor ID
- 2022/0037
- Conditions
- Tooth Discoloration
- Keywords
- chitosan nanoparticles, Diode laser, carbamide peroxide, nonvital teeth bleaching
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 17 Jan 2025 (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 growing demand for white smile between patients has increased over recent years, the development of techniques and improvement of materials permits searching for beautiful natural smile.
The discoloration of teeth might be intrinsic, extrinsic, or combined. A variety of commercial bleaching agents is available. The most common substances used are carbamide peroxide or hydrogen peroxide or a mixture of sodium perborate and hydrogen peroxide.
Detailed description
The aim of the study is to assess the effectiveness of two different in-office bleaching materials carbamide peroxide alone and carbamide peroxide with Chitosan nanoparticles Using diode laser as an activator Regarding tooth whitening and color stability 1 Day , 1 weeks, 1 month after treatment using Vita easy shade.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peroxides and sodium perborate and 980nm diode laser. | Other | Drug: nano chitosanperoxides and sodium perborate + 980nm diode laser. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- discolored crown, non-vital or endodontically treated upper central and lateral incisors
- previous endodontic treatment performed two or more years earlier.
Key exclusion criteria (1 listed)
- caries on upper central and lateral incisors, inadequate fillings, and progressive periodontal disease.
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 |
|---|---|---|
| nano chitosannano chitosan | Drug | peroxides and sodium perborate and 980nm diode laser. |
Primary outcome
Color change
Time frame: these assessments were performed for 1 day, 1 week, and 1 month after treatment with Vita easy shade.
these assessments were performed for 1 day, 1 week, and 1 month after treatment with Vita easy shade obtaining difference ∆E* values using colorcoordinates CIE L*, a* and b*
color change using digital vita easy shade guide
Time frame: 1 day , 1 week , 1 month
color change using digital vita easy shade guide
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 25 Sep 2025.
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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.
Manal abd el baky A dr, phd study director
Lecturer in conservative surgery departement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing nano chitosan in people with Tooth Discoloration, run by Misr University for Science and Technology 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 2 inclusion and 1 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 25 Sep 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: these assessments were performed for 1 day, 1 week, and 1 month after treatment with Vita easy shade.). The study lists 2 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 25 Sep 2025.