Discolored TeethNCT07770373
Effect of Prophylaxis Pastes With and Without Desensitizing Agents Prior to In-office Bleaching
A study testing Treatment in people with Discolored Teeth, run by Cairo University.
Trial summary
To evaluate the effect of prophylaxis pastes with and without desensitizing agents prior to in-office bleaching on color change and tooth sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Discolored Teeth
- What is being tested?
- Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Aug 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who have discolored teeth, minimum of 20 natural teeth, good oral hygiene, do not have any systemic disease.
Who cannot join
- Patients who have extensive prosthesis or restoration, tetracycline discoloration or fluorosis, endodontically treated teeth or gingival recession, smokers, periodontal disease, pregnant or lactating.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Prophylaxis Pastes With and Without Desensitizing Agents Prior to In-office Bleaching on Color Change and Tooth Sensitivity: Randomized Clinical Trial
To evaluate the effect of prophylaxis pastes with and without desensitizing agents prior to in-office bleaching on color change and tooth sensitivity.
- Conditions
- Discolored Teeth
- Being tested
- Treatment
- Keywords
- bleaching, desensitizing agents, discoloration
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentOther
Prophylaxis paste will be applied to all tooth surfaces using a prophy cup attached to a low-speed contra-angle handpiece. The paste will remain on the teeth for the duration specified in the manufacturer's instructions for use before being rinsed away.
| Study group | Role | What they receive |
|---|---|---|
| Prophylaxis paste with desensitizing agent | Experimental | Prophylaxis paste with desensitizing agent Receives: Other: Treatment |
| Prophylaxis paste without desensitizing agent | Placebo comparator | Prophylaxis paste without desensitizing agent Receives: Other: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color change
Tooth color will be measured using the VITA Easyshade V spectrophotometer. Color measurements will be recorded in the CIE L*, a*, and b* color space, and the color difference will be calculated using the CIEDE2000 color-difference formula (ΔE00).
Measured: Baseline, Immediate after bleaching
Secondary outcomes (1)
Tooth sensitivity
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable). Patients will be asked to place a mark on the 10-cm VAS corresponding to the intensity of their pain.
Measured: Baseline, Immediate after bleaching
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discolored TeethStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Omar Tolba, Cairo University
- Investigators
- Zeinab O Tolba, Associate Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770373
- Sponsor's protocol ID
- Dental desensitizing agent
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prophylaxis Pastes With and Without Desensitizing Agents Prior to In-office Bleaching on Color Change and Tooth Sensitivity: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07770373
- Acronym / sponsor ID
- Dental desensitizing agent
- Conditions
- Discolored Teeth
- Keywords
- bleaching, desensitizing agents, discoloration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 18 Aug 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.
To evaluate the effect of prophylaxis pastes with and without desensitizing agents prior to in-office bleaching on color change and tooth sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylaxis paste with desensitizing agent | Experimental | Other: TreatmentProphylaxis paste with desensitizing agent |
| Prophylaxis paste without desensitizing agent | Placebo comparator | Other: TreatmentProphylaxis paste without desensitizing agent |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who have discolored teeth, minimum of 20 natural teeth, good oral hygiene, do not have any systemic disease.
Key exclusion criteria (1 listed)
- Patients who have extensive prosthesis or restoration, tetracycline discoloration or fluorosis, endodontically treated teeth or gingival recession, smokers, periodontal disease, pregnant or lactating.
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 |
|---|---|---|
| TreatmentProphylaxis paste will be applied to all tooth surfaces using a prophy cup attached to a low-speed contra-angle handpiece. The paste will remain on the teeth for the duration specified in the manufacturer's instructions for use before being rinsed away. | Other | Prophylaxis paste with desensitizing agent, Prophylaxis paste without desensitizing agent |
Primary outcome
Color change
Time frame: Baseline, Immediate after bleaching
Tooth color will be measured using the VITA Easyshade V spectrophotometer. Color measurements will be recorded in the CIE L*, a*, and b* color space, and the color difference will be calculated using the CIEDE2000 color-difference formula (ΔE00).
1 secondary outcome
Tooth sensitivity
Time frame: Baseline, Immediate after bleaching
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 18 Aug 2026.
- 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.
Zeinab O Tolba, Associate Professor principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Discolored Teeth, run by Cairo University.
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 1 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: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Zeinab O Tolba, Associate Professor (+2 01222308738, zeinab.omar@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color change (time frame: Baseline, Immediate after bleaching). 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 18 Aug 2026.