Tooth DiscolorationNCT06904118
Clinical Efficacy of Novel Titanium Oxide Nanoparticle Enriched Bleaching Gel
A study testing Nano-reinforced Novel Hydrogen peroxide gel and Conventional Hydrogen peroxide gel without nanoparicles in people with Tooth Discoloration and Tooth Sensitivity, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn the effect of Nano-fortified Bleaching on whitening and sensitivity of teeth.The main questions it aims to answer are: Does Nano-fortified Bleaching gel is more effective in enhancing the whitening in comparison to conventional bleaching gel ? Does Nano-fortified Bleaching… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration, Tooth Sensitivity
- What is being tested?
- Nano-reinforced Novel Hydrogen peroxide gel and Conventional Hydrogen peroxide gel without nanoparicles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jun 2024to 27 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria:Patients enrolled in the current trial ranged between 20- 40 years old with good general and oral health. Participants selected without any caries, restorations or periodontal disease in anterior teeth. The selected participants possessed maxillary incisors having shade A3 or darker after checking with Vita Classical Shade Guide
Exclusion Criteria:The patients having poor oral hygiene; caries, restorations, periodontal disease, root canal treatment, fractures, gingival recessions, cervical lesions, bruxism, severe internal discoloration, dental prosthesis, cracks and spontaneous TS, in anterior teeth shall be excluded from this study. Moreover, pregnant, lactating women, smokers, patients taking medications, those having fixed orthodontic appliances and undergone tooth whitening will be also excluded
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
School of Dentistry, Pakistan Institute of Medical Sciences
Islamabad, Punjab Province, 44080
About this study
Official title: Clinical Efficacy of Novel Titanium Oxide Nanoparticle Enriched Bleaching Gel on Tooth Whitening and Hypersensitivity: A Randamized Clinical Trial.
The goal of this clinical trial is to learn the effect of Nano-fortified Bleaching on whitening and sensitivity of teeth.The main questions it aims to answer are:
Does Nano-fortified Bleaching gel is more effective in enhancing the whitening in comparison to conventional bleaching gel ? Does Nano-fortified Bleaching gel is more effective in declining the sensitivity in comparison to conventional bleaching gel ?
Participants will be divided into 2 groups i.e Group A where Nano-fortified Bleaching agent will be employed and Group B where Conventional Bleaching agent without nanoparticles will be used. Two application of bleaching for 16 minutes twice with total of thirty two minutes in a single session will be carried out . Tooth sensitivity will be measured by VAS Scale having "No Pain" at one-end and "Worst Pain" at opposite-end .Color change will be measured with spectrophotometer.
Read the detailed description
This triple blinded randomized clinical trial will be performed where Participants without any caries, restorations or periodontal disease in anterior teeth having shade A3 or darker will be included in this trial. Those having poor oral hygiene; caries, restorations, periodontal disease, root canal treatment, fractures, gingival recessions, cervical lesions, bruxism, severe internal discoloration, dental prosthesis, cracks and spontaneous TS, in anterior teeth will be excluded. Consecutive non probability sampling technique will be used where total participants (n=60) will be randomly allocated into two groups 'A' and 'B' (n= 30). After informed consent, bleaching protocol will be carried out in both the groups 'A' and 'B'with conventional and novel bleaching gel. The color change (ΔE) and post bleaching hypersensitivity scores will be recorded by Visual analogue scale (VAS). In group A; Nano-fortified Novel TiHP gel (Titanium Dioxide nanoparticles and 25 % Hydrogen Peroxide ) will be used for the participants of Group-A and Conventional bleaching gel (25 % Hydrogen Peroxide) will be utilized for participants of Group-B. The color change (ΔE) will be investigated via spectrophotometer and VAS score will be calculated by participants who will be instructed to rate their hypersensitivity scores after 1st session, 2nd session, 3rd session and post-bleaching after 1 week and 1 month
- Conditions
- Tooth Discoloration, Tooth Sensitivity
- Being tested
- Nano-reinforced Novel Hydrogen peroxide gel, Conventional Hydrogen peroxide gel without nanoparicles
- Keywords
- Biowaste,, Hypersensitivity, Silky Corn Hair Fiber, Titanium oxide nanoparticles (TiO2 Nps), whitening
- Medical subject headings
- Tooth Discoloration, Dentin Sensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-reinforced Novel Hydrogen peroxide gelDrug
Group A (Novel Nano-enriched Hydrogen peroxide bleaching gel with Silky Corn hair fiber derived- titania nanoparticles)
Conventional Hydrogen peroxide gel without nanopariclesDrug
Drug: Hydrogen peroxide without nanoparicles Group B ( Conventional Hydrogen peroxide gel without nanoparticles)
| Study group | Role | What they receive |
|---|---|---|
| Group-A | Experimental | Experimental: Group A (Nano-reinforced Hydrtogen peroxide ) Nano-reinforced hydrogen peroxide bleaching gel Receives: Drug: Nano-reinforced Novel Hydrogen peroxide gel |
| Group-B | Experimental | Group-B (Conventional Hydrogen peroxide) Conventional Hydrogen peroxide gel without nanoparticles Receives: Drug: Conventional Hydrogen peroxide gel without nanoparicles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-bleaching sensitivity
Pain scores assessed by Visual Analogue Scale (VAS) score after 4hr, 24hrs, 48hrs, 72hrs, 96hrs. The minimum score is O (None) and the maximum score is 10 (Severe)
Measured: 3 months
Secondary outcomes (1)
Post-bleaching whitening
Color change shall be measured with spectrophotometer; and calculated through formula; ΔE = [(ΔL*)2 + (Δa*)2 + (Δb*)2 ] 1/2 with different readings taken by two calibrated evaluators.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start13 Jun 2024
- Primary completion27 Dec 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional Study Model: Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Afsheen Mansoor, Pakistan Institute of Medical Sciences
- Investigators
- Afsheen Mansoor, PhD, Principal investigator, School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904118
- Sponsor's protocol ID
- SOD/ ERB/2023/31-01
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coppla FM, Rezende M, de Paula E, Farago PV, Loguercio AD, Kossatz S, Reis A. Combination of Acetaminophen/Codeine Analgesics Does Not Avoid Bleaching-Induced Tooth Sensitivity: A Randomized, Triple-Blind Two-Center Clinical Trial. Oper Dent. 2018 Mar/Apr;43(2):E53-E63. doi: 10.2341/17-092-C.
PubMed 29504880
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Novel Titanium Oxide Nanoparticle Enriched Bleaching Gel on Tooth Whitening and Hypersensitivity: A Randamized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06904118
- Acronym / sponsor ID
- SOD/ ERB/2023/31-01
- Conditions
- Tooth Discoloration, Tooth Sensitivity
- Keywords
- Biowaste,, Hypersensitivity, Silky Corn Hair Fiber, Titanium oxide nanoparticles (TiO2 Nps), whitening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 1 Apr 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 goal of this clinical trial is to learn the effect of Nano-fortified Bleaching on whitening and sensitivity of teeth.The main questions it aims to answer are:
Does Nano-fortified Bleaching gel is more effective in enhancing the whitening in comparison to conventional bleaching gel ? Does Nano-fortified Bleaching gel is more effective in declining the sensitivity in comparison to conventional bleaching gel ?
Participants will be divided into 2 groups i.e Group A where Nano-fortified Bleaching agent will be employed and Group B where Conventional Bleaching agent without nanoparticles will be used. Two application of bleaching for 16 minutes twice with total of thirty two minutes in a single session will be carried out . Tooth sensitivity will be measured by VAS Scale having "No Pain" at one-end and "Worst Pain" at opposite-end .Color change will be measured with spectrophotometer.
Detailed description
This triple blinded randomized clinical trial will be performed where Participants without any caries, restorations or periodontal disease in anterior teeth having shade A3 or darker will be included in this trial. Those having poor oral hygiene; caries, restorations, periodontal disease, root canal treatment, fractures, gingival recessions, cervical lesions, bruxism, severe internal discoloration, dental prosthesis, cracks and spontaneous TS, in anterior teeth will be excluded. Consecutive non probability sampling technique will be used where total participants (n=60) will be randomly allocated into two groups 'A' and 'B' (n= 30). After informed consent, bleaching protocol will be carried out in both the groups 'A' and 'B'with conventional and novel bleaching gel. The color change (ΔE) and post bleaching hypersensitivity scores will be recorded by Visual analogue scale (VAS). In group A; Nano-fortified Novel TiHP gel (Titanium Dioxide nanoparticles and 25 % Hydrogen Peroxide ) will be used for the participants of Group-A and Conventional bleaching gel (25 % Hydrogen Peroxide) will be utilized for participants of Group-B. The color change (ΔE) will be investigated via spectrophotometer and VAS score will be calculated by participants who will be instructed to rate their hypersensitivity scores after 1st session, 2nd session, 3rd session and post-bleaching after 1 week and 1 month
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional Study Model: Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Group-A | Experimental | Drug: Nano-reinforced Novel Hydrogen peroxide gelExperimental: Group A (Nano-reinforced Hydrtogen peroxide ) Nano-reinforced hydrogen peroxide bleaching gel |
| Group-B | Experimental | Drug: Conventional Hydrogen peroxide gel without nanopariclesGroup-B (Conventional Hydrogen peroxide) Conventional Hydrogen peroxide gel without nanoparticles |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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-reinforced Novel Hydrogen peroxide gelGroup A (Novel Nano-enriched Hydrogen peroxide bleaching gel with Silky Corn hair fiber derived- titania nanoparticles) | Drug | Group-A |
| Conventional Hydrogen peroxide gel without nanopariclesDrug: Hydrogen peroxide without nanoparicles Group B ( Conventional Hydrogen peroxide gel without nanoparticles) | Drug | Group-B |
Primary outcome
Post-bleaching sensitivity
Time frame: 3 months
Pain scores assessed by Visual Analogue Scale (VAS) score after 4hr, 24hrs, 48hrs, 72hrs, 96hrs. The minimum score is O (None) and the maximum score is 10 (Severe)
1 secondary outcome
Post-bleaching whitening
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Results publication: PubMed 29504880Coppla FM, Rezende M, de Paula E, Farago PV, Loguercio AD, Kossatz S, Reis A. Combination of Acetaminophen/Codeine Analgesics Does Not Avoid Bleaching-Induced Tooth Sensitivity: A Randomized, Triple-Blind Two-Center Clinical Trial. Oper Dent. 2018 Mar/Apr;43(2):E53-E63. doi: 10.2341/17-092-C.
- Coppla, F. M., Rezende, M., de Paula, E., Farago, P. V., Loguercio, A. D., Kossatz, S., \& Reis, A. (2018). Combination of Acetaminophen/Codeine Analgesics Does Not Avoid Bleaching-Induced Tooth Sensitivity: A Randomized, Triple-Blind Two-Center ClinicalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Afsheen Mansoor, PhD principal investigator
School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nano-reinforced Novel Hydrogen peroxide gel and Conventional Hydrogen peroxide gel without nanoparicles in people with Tooth Discoloration and Tooth Sensitivity, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 31 Aug 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-bleaching sensitivity (time frame: 3 months). 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 NCT06904118, which also lists 1 linked publication.
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 31 Aug 2026.